What is osteoporosis?

The word “osteoporosis” means “porous bone.” It is a bone-weakening disease, and if you have it, you are at increased risk of sudden and unexpected bone fractures. Osteoporosis means you have less bone mass and strength. The disease often develops without symptoms or pain and is usually not discovered until weakened bones cause painful fractures. Most of these are fractures of the hip, wrist, and spine.

Who gets osteoporosis?

It is estimated that around 200 million people have osteoporosis worldwide. In the US, the figure is about 54 million people. Although osteoporosis occurs in both men and women, women are four times more likely to develop the disease than men. Currently, there are about two million men in the US who have osteoporosis and about 12 million more who are at risk of developing the condition.

After age 50, one in two women and one in four men will have an osteoporosis-related fracture at some point in their lives. Another 30% have low bone density that puts them at risk of developing osteoporosis. This condition is called osteopenia. Osteoporosis is responsible for more than two million fractures each year, and this number continues to grow. There are steps you can take to prevent osteoporosis from occurring. Treatments can also slow the rate of bone loss if you have osteoporosis.

What causes osteoporosis?

Researchers understand how osteoporosis develops even without knowing the exact cause of why it develops. Your bones are made of living, growing tissue. The inside of a healthy bone looks like a sponge. This area is called trabecular bone. An outer layer of dense bone surrounds the cancellous bone. This hard layer is called cortical bone.

When osteoporosis occurs, the “holes” in the “sponge” get larger and more numerous, weakening the inside of the bone. Bones support the body and protect vital organs. Bones also store calcium and other minerals. When the body needs calcium, it breaks down and rebuilds bones. This process, called bone remodelling, provides the body with needed calcium while keeping bones strong.

Until about age 30, you typically build more bone than you lose. After age 35, bone breakdown occurs faster than bone buildup, leading to a gradual loss of bone mass. If you have osteoporosis, you lose bone mass at a higher rate. After menopause, the rate of bone breakdown occurs even more rapidly.

What are the symptoms of osteoporosis?

There are usually no symptoms of osteoporosis. That is why it is sometimes called a silent disease. However, you should be careful about the following things:

  • Height loss (shortening of an inch or more).
  • Change of posture (bend over or lean forward).
  • Difficulty breathing (decreased lung capacity due to compressed discs).
  • bone fractures
  • Lower back pain.

Who is at risk of developing osteoporosis?

There are many risk factors that increase the possibility of developing osteoporosis, two of the most important being gender and age.

1. Everyone’s risk of osteoporotic fractures increases with age. However, women over the age of 50 or postmenopausal are at the highest risk of developing osteoporosis. Women experience rapid bone loss in the first 10 years after entering menopause, because menopause slows the production of estrogen, a hormone that protects against excessive bone loss.

Age and osteoporosis also affect men. You may be surprised to learn that men over the age of 50 are more likely to have an osteoporosis-induced bone fracture than to develop prostate cancer. About 80,000 men a year are expected to break their hip, and men are more likely than women to die in the year after a hip fracture.

2. Your risk of developing osteoporosis is also related to ethnicity. Caucasian and Asian women are more likely to develop osteoporosis. However, African American and Hispanic women are still at risk. In fact, African-American women are more likely than white women to die after a hip fracture.

3. Another factor is bone structure and body weight. Small, thin people are at higher risk of developing osteoporosis because they have less bone to lose than people with more body weight and larger frames.

4. Family history also plays a role in the risk of osteoporosis. If your parents or grandparents have had signs of osteoporosis, such as a hip fracture after a minor fall, you may be at higher risk of developing the disease.

5. Finally, some medical conditions and medications increase your risk. If you have or have had any of the following conditions, some of which are related to irregular hormone levels, you and your health care provider might consider early detection of osteoporosis.

  • An overactive thyroid, parathyroid, or adrenal glands.
  • History of bariatric surgery (weight loss) or organ transplant.
  • Hormonal treatment for breast or prostate cancer or a history of missed periods.
  • Celiac disease or inflammatory bowel disease.
  • Blood diseases such as multiple myeloma.

Some medications cause side effects that can damage bones and lead to osteoporosis. These include steroids, breast cancer treatments, and medications to treat seizures. You should talk to your health care provider or pharmacist about the effect of your medications on your bones.

It may seem like every risk factor is related to something out of your control, but that’s not true. You have control over some of the risk factors for osteoporosis. You can discuss medication problems with your health care provider. AND—you are in charge of your:

  • Eating habits: You are more likely to develop osteoporosis if your body does not have enough calcium and vitamin D. Although eating disorders such as bulimia or anorexia are risk factors, they can be treated.
  • Lifestyle: People who lead sedentary (inactive) lifestyles have a higher risk of osteoporosis.
  • Tobacco use: Smoking increases the risk of fractures.
  • Alcohol consumption: Drinking two drinks a day (or more) increases the risk of osteoporosis.

How is osteoporosis diagnosed?

Your health care provider may order a test to give you information about your bone health before problems start. Bone mineral density (BMD) tests are also known as dual-energy X-ray absorptiometry (DEXA or DXA) scans. These x-rays use very small amounts of radiation to determine how strong the bones of the spine, hip, or wrist are.

Regular X-rays will only show osteoporosis when the disease is very advanced. All women over the age of 65 should have a bone density test. DEXA scanning may be done earlier in women who have risk factors for osteoporosis. Men over the age of 70 or younger men with risk factors should also consider having a bone density test.

How is osteoporosis treated?

Treatments for established osteoporosis may include exercise, vitamin and mineral supplements, and medications. Exercise and supplementation are often suggested to help prevent osteoporosis. Loading, resistance and balance exercises are all important.

What medications are used to treat osteoporosis?

There are several classes of drugs used to treat osteoporosis. Your health care provider will work with you to find the best option. It is really not possible to say that there is a better medicine to treat osteoporosis. The “best” treatment is the one that is best for you.

  • Hormonal and hormone-related therapy

This class includes estrogen, testosterone, and the selective estrogen receptor modulator raloxifene (Evista®). Due to the potential for blood clots, certain cancers, and heart disease, estrogen therapy is likely to be used in women who need to treat menopausal symptoms and in younger women. Testosterone may be prescribed to increase bone density if you are a man with low levels of this hormone.

Raloxifene acts like estrogen in the bones. The drug is available in tablet form and is taken every day. In addition to treating osteoporosis, raloxifene might be used to reduce the risk of breast cancer in some women. For osteoporosis, raloxifene is usually used for five years.

Salmon-calcitonin (Fortical® and Miacalcin®) is a synthetic hormone. It reduces the chance of spinal fractures, but not necessarily hip fractures or other types of fractures. It can be injected or inhaled through the nose. Side effects include runny or nosebleeds and headaches for the inhaled form. Side effects include rashes and redness from the injected form. It is not recommended as a first option. More serious side effects are possible, including a weak link to cancer.

  • Bisphosphonates

Treatments for osteoporosis with bisphosphonates are considered antiresorptive drugs. They prevent the body from reabsorbing bone tissue. There are several formulations with various dosage schedules (monthly, daily, weekly and even yearly) and different brands:

Alendronate: Fosamax®, Fosamax Plus D®, Binosto®.
Ibandronate: Boniva®.
Risedronate: Actonel®, Atelvia®.
Zoledronic acid: Reclast®.

You may be able to stop taking bisphosphonates after three to five years and still get benefits after you stop taking them. Also, these drugs are available as generic drugs. Of these products, Boniva and Atelvia are recommended only for women, while the others can be used by both women and men.

Possible side effects of bisphosphonates include flu-like symptoms (fever, headache), heartburn, and impaired kidney function. There are also potentially serious side effects, such as the rare occurrence of jaw bone damage (osteonecrosis of the jaw) or atypical femur fractures (mild trauma thigh fractures). The risk of these rare events increases with prolonged use of the drug (>5 years).

  • Biological products

Denosumab (Prolia®) is a product that is available as an injection given every six months to women and men. It is often used when other treatments have failed. Denosumab can even be used in some cases of reduced kidney function. Its long-term effects are not yet known, but there are potentially serious side effects. These include possible problems with the thigh or jawbones and serious infections.

  • Anabolic agents

These products strengthen bones in people who have osteoporosis. There are three of these products currently approved:

1. Romososumab-aqua (Evenity®) has been approved for postmenopausal women who are at high risk of fracture.

2. The product allows the formation of new bone and decreases the breakdown of bone. You will receive two injections, one after the other, once a month. The time limit is one year for these injections.

3. Teriparatide (Forteo®) and Abaloparatide (Tymlos®) are injectable medications that are given daily for 2 years. They are parathyroid hormones, or products similar in many ways to hormones.

Neuromuscular Junction


The neuromuscular junction (NMJ) is a synaptic connection between the terminal end of a motor nerve and a muscle (skeletal/smooth/cardiac). It is the site for the transmission of the action potential from the nerve to the muscle. It is also a site for many diseases and a site of action for many pharmacological drugs. In this article, the UNM of skeletal muscle will be discussed.

Matters of interest

NMJ diseases produce muscle weakness through different mechanisms that can affect the presynaptic, synaptic, or postsynaptic portions of the NMJ. The three main diseases involving the NMJ are myasthenia gravis (MG), Lambert-Eaton syndrome (SLE), and botulism.

Physiologic Anatomy of the Neuromuscular Junction

For convenience and understanding, the structure of the Neuromuscular Junction (NMJ) can be divided into three main parts: a presynaptic part (nerve terminal), a postsynaptic part (motor endplate), and an area between the nerve terminal and the motor endplate (synaptic cleft). ).

Nerve Terminal:

A myelinated motor neuron, upon reaching the target muscle, loses its myelin sheath to form a complex of 100-200 branching nerve endings. These nerve endings are called nerve endings or terminal buttons. The nerve terminal membrane has areas of membrane thickening called active zones. The active zones have a family of SNAP proteins (syntaxins and synaptosome-associated protein 25) and rows of voltage-gated calcium (Ca) channels. A nerve terminal also has potassium channels in its membrane and contains mitochondria, endoplasmic reticulum, and synaptic vesicles (SV).

Each SV stores about 5,000-10,000 molecules of acetylcholine (ACh), the neurotransmitter in NMJ. The SVs are concentrated around the active zone. The SV membrane has synaptotagmin and synaptobrevin proteins. These proteins are essential for SV fusion and docking at active sites. Upon the arrival of an action potential at the nerve ending, Ca channels open to cause inflow. The increase in Ca within the nerve terminal causes a series of events that lead to docking of SVs at active sites and exocytosis of ACh from synaptic vesicles into the synaptic cleft.

Synaptic cleft/junctional cleft:

The space between the nerve terminal and the muscle plasma membrane is called the synaptic/junctional cleft and measures approximately 50 nm. It is the site where the presynaptic neurotransmitter ACh is released before it interacts with nicotinic ACh receptors on the motor endplate. The synaptic cleft of the NMJ contains the enzyme acetylcholinesterase, responsible for the catabolism of the released ACh so that its effect on postsynaptic receptors is not prolonged.

Motor End Plate forms the postsynaptic part of NMJ. It is the thickened portion of the muscle’s plasma membrane (sarcolemma) that folds to form depressions called junctional folds. The terminal nerve endings do not penetrate the motor endplate but fit into the junctional folds. The junctional folds have nicotinic ACh receptors concentrated at the top. These receptors are ACh-gated ion channels. The binding of ACh to these receptors opens the channels that allow sodium ions to enter the muscle membrane from the extracellular fluid. This creates an endplate potential and generates and transmits AP to the muscle membrane.


ACh is synthesized at the presynaptic terminal using choline and acetyl-CoA and the enzyme choline acetyltransferase. It then goes through a series of modifications before being packaged in vesicles. Upon depolarization, an action potential travels down the axon, causing voltage-gated calcium channels to open, resulting in an influx of calcium ions into the nerve terminal. This causes the vesicles to migrate towards the nerve terminal membrane and fuse with the active zones.

Different vesicular proteins (SNAP-25, syntaxin) and nerve terminal membrane proteins (synaptobrevin and synaptotagmin) play a role in the fusion of SV to active zones and the exocytosis of ACh in the synaptic cleft. The released ACh subsequently binds to nicotinic ACh receptors at the junctional folds of the motor endplate. The binding of ACh to receptors triggers the opening of ACh-gated ion channels that allow sodium ions to enter the muscle.

Sodium influx changes the postsynaptic membrane potential from -90 mV to -45 mV. This decrease in membrane potential is called the endplate potential. At the NMJ, the endplate potential is strong enough to propagate the action potential over the skeletal muscle membrane surface that ultimately resulting in muscle contraction. To prevent sustained depolarization and muscle contraction, as well as to allow repolarization, acetylcholinesterase metabolizes ACh into its subunits, choline and acetate. Choline can then be reused for ACh synthesis.

Clinical significance

Some of the pharmacology related to the NUM was previously mentioned in the pathophysiology section. The rest will be covered here. There are some chemicals that cause irreversible inhibition of ACh esterase, the enzyme responsible for breaking down ACh into choline and acetic acid in the synaptic cleft. This results in the accumulation of ACh throughout the nervous system, resulting in overstimulation of muscarinic and nicotinic receptors. Irreversible inhibitors of ACh esterase include Malathion and Parathion. These are commonly used as insecticides. The effects of organophosphates are reversed using a competitive inhibitor such as atropine and/or pralidoxime, which regenerates ACh esterase if administered early enough before enzyme ageing occurs through hydrolysis of the R group.

Others include the central-acting type, such as rivastigmine, galantamine, tacrine, and donepezil. These are used to treat Alzheimer’s dementia. Another pharmacological importance involves the use of NMJ blockers to induce muscle paralysis in anesthesiology. Neuromuscular blockers can be classified as depolarizing (succinylcholine) and non-depolarizing (tubocurarine, atracurium, mivacurium, pancuronium, vecuronium, rocuronium). Depolarizing agents function as an agonist of the ACh receptor at the NMJ, producing a sustained depolarization that prevents depolarization of the motor endplate, resulting in ACh receptors becoming desensitized and inactivated.

Nondepolarizing agents behave as competitive antagonists and compete with ACh for receptors. In addition, nondepolarizing neuromuscular blockers are the alternative when the patient is a poor metabolizer of pseudocholinesterase (the enzyme that breaks down succinylcholine) or has a mutation in the ryanodine receptor, both of which prolong the action of succinylcholine and can lead to death. a complication of malignant hyperthermia due to sustained muscle contraction.

Direct ACh agonists that bind directly to ACh receptors include bethanechol (used to treat postoperative ileus, urinary retention), carbachol and pilocarpine (both used to treat pupillary muscle constriction glaucoma), and methacholine (Used for a provocation test to diagnose asthma in a patient who is asymptomatic). Lastly, botulinum toxin can be administered medically to relieve sustained muscle contraction in cases of blepharospasm, dystonia, and achalasia.

Oocyte Development During the Reproductive Cycle

An oocyte is an immature ovum (an immature ovum). Oocytes develop to maturity from within a follicle. These follicles are found in the outer layer of the ovaries. During each reproductive cycle, several follicles begin to develop. Usually, only one oocyte in each cycle will develop into a mature egg and ovulate from its follicle. This process is known as ovulation. A woman is born with all the oocytes she will ever have. This number naturally decreases with age. Age also reduces the quality and genetic stability of oocytes. This is why it is more difficult to get pregnant after 35.

The full maturation of the Follicule and Oocyte ovum is visible to the human eye and measures 0.1 mm. It is about the size of the period at the end of this sentence. Medications known as fertility drugs can stimulate the ovaries to release multiple oocytes during a menstrual cycle. used to stimulate the ovaries to produce multiple oocytes instead of ovulating as mature eggs. This is the cause of the increased risk of multiple pregnancies when taking fertility drugs. For every ovulated egg, there is a chance that it will be fertilized by a sperm. These fertilized eggs can develop into embryos (and eventually, if all goes well, babies).

During fertility treatments, the doctor will perform ultrasound scans to monitor the growth of the follicles. Oocyte maturation is also taking place, but oocyte maturation is not visible on ultrasound. This is why the growth of follicles and not of oocytes is observed. If too many follicles grow, your treatment cycle may be cancelled to prevent the risk of multiple pregnancies or ovarian hyperstimulation syndrome (OHSS). During in vitro fertilization (IVF), if ultrasound monitoring does not show sufficient follicle growth, meaning not enough oocytes are maturing, the cycle can be cancelled to prevent treatment failure.

Oocyte stages

Oogenesis is what an oocyte goes through as it develops into a mature egg cell. You can assume that oogenesis occurs over the course of a month since that is how often you ovulate. But you would be wrong! While it is true that any egg that ovulates completes the process of oogenesis in the month that it is released from the ovary, oocyte development began long before you were born. In fact, it started when you were a very young embryo.

Primordial germ cell

The “seed” cell of each oocyte is the primordial germ cell. These are embryonic cells that will eventually become sperm or oocytes. In the developing embryo, these cells move into the area that will eventually become the testicles or ovaries (also known as the gonads).

(Interesting side note: Research published in 2012 found that some of these stem cells from early oocytes are present in the ovaries of adult women. There may be away in the future to take these stem cells and create new oocytes. This would mean that women will no longer be limited to the eggs they were born with).


Once the primordial germ cell reaches the gonads, it is influenced by surrounding cells to become an oogonium (plural, oogonia). Oogonia are diploid cells. This means that they have two (di) complete sets of chromosomes. In the human cell, this is 23 pairs or a total of 46. This is important to know because the oocyte will eventually have only half or 23 chromosomes. (During fertilization, you’ll get the other 23 of the sperm to have a complete set once again.)

During the first five months of prenatal development, the oogonium increases in number through a process known as mitotic cell division. Meiosis is exclusive to germ cells. It only occurs in young eggs and sperm. In a more typical cell division, known as meiosis, cells duplicate by creating clones of themselves, each with a complete set of chromosomes. For example, a skin cell that goes through mitosis will eventually lead to two skin cells, with similar genetic codes.

During mitotic cell division, the oogonium divides into two separate cells containing:

  • Only half of a chromosome set: In other words, they only have 23 chromosomes. (These are known as haploid cells).
  • Unique Chromosomal Sets: Each oogonium that divides creates unique sister cells. This means that no oogonium shares the same chromosome composition as another.

This mitotic division is the reason that each new life has a unique genetic makeup that is unlike any other. However, it is not completely random. Everything is based on the original genetic material that the embryo received from its father and mother. These cells continue to multiply until they reach their peak. The peak occurs when the developing fetus is about five months old. At this point, the girl fetus has 7 million oocytes. This number will start to decrease after this point. At birth, a girl has only 2 million oocytes left.

Primary oocyte

Each oocyte will go through two separate meiotic cell divisions before becoming a mature ovum. Meiotic cell division leads to the growth and maturity of the oocyte, not additional oocytes. Towards the end of prenatal development, the oocytes stop multiplying and begin to mature individually. At this stage, they go through the first meiotic cell division. This cell division leads to the growth of oocytes, not more oocytes, as occurs with the oogonium. But they don’t just accelerate development to maturity right now. Primary oocytes are frozen in their development and remain frozen until reproductive hormones trigger the next stage. Oogenesis will continue at the age of puberty.

Secondary oocyte

Puberty initiates the next stage of oocyte maturity. Of course, not all oocytes will go through these later stages of oocyte development together. They more or less take turns during a woman’s reproductive years. Each month, a new set of primary oocytes begins to mature.

Once a primary oocyte is affected by reproductive hormones, it completes Stage I of meiotic cell division. This is known as oocyte maturation. At the end of this first stage of meiotic cell division, the cell divides into two separate cells: a small polar body and a large secondary oocyte. The small polar body eventually decays. The secondary oocyte begins the next stage of maturation.


The oocyte now begins the second phase of meiotic cell division. Eventually, the secondary oocyte will divide again into two separate cells: another small polar body cell and a larger mature cell. This larger mature cell is known as the ootide. As before, the smaller polar body cell will eventually deteriorate. Ovulation occurs when the oocyte has reached the ootid stage of development.


At the time of ovulation, and outside is released from the follicle. Human eggs cannot move on their own. Instead, the finger-like projections draw the oocyte toward and into the fallopian tube. Once inside the fallopian tube, small hair-like projections known as cilia continue to drag the ootide.

In the fallopian tube, if a pregnancy occurs, the egg is fertilized by a sperm. Once this fertilization takes place, the ovum goes through its final stage of maturation and becomes an ovum, a fully mature human ovum. So is; the oocyte cannot actually complete its full development without fertilization.

From oocyte to ovum to zygote

During fertilization, the egg and sperm combine, each with 23 chromosomes. Quite quickly (but not at the exact time of fertilization), these chromosomes fuse together, creating a new cell with a complete set of chromosomes. This new cell is called a zygote. The zygote will develop into an embryo and, about nine months later, into a newborn baby.

Scientists Identify Corona virus Strain

Scientists Identify Corona virus Strain In Cyprus-‘Deltacron’-That Blends Delta And Omicron

Scientists in Cyprus have found 25 cases of a strain of the coronavirus that they say combines elements of the delta and omicron variants, dubbing it “deltacron,” with a high proportion of the variant found in patients hospitalized for Covid-19

People at the Larnaca International Airport in Cyprus (Photo by CHRISTINA ASSI/AFP via Getty Images)


  • The discovery was made by Leondios Kostrikis, professor of biological sciences at the University of Cyprus and head of the Laboratory of Biotechnology and Molecular Virology, and his team, Bloomberg reported
  • The new strain has “omicron-like genetic signatures within the delta genomes,” according to Bloomberg
  • Deltacron cases were found in 25 samples taken in Cyprus, of which 11 were from patients hospitalized with Covid and 14 from the general public, according to Cyprus Maila local English daily.

Analysis shows deltacron is more often found in patients hospitalized with Covid-19 than those with Covid-19 who are not hospitalized, Kostrikis said.

It is “quite possible” that the new strain has not been found elsewhere, and the sequences of the cases have been sent to GISAID, a Germany-based international database that tracks developments in the coronavirus, the Cyprus Mail reported.

Australia’s Last Zero‑CovidHoldout Cancels Border Reopening Plans As Omicron Surges Across Country


In December 2021, Paul Burton, Moderna’s chief medical officer, told the U.K.’s House of Commons that the co-existence of delta and omicron increased the chances of a new variant as a result of them trading genes, the Daily Mail reported. Such recombination is common in coronaviruses, according to the New York TimesSeveral studies have suggested recombination could cause the virus to change in “dangerous ways,” but could help researchers develop drugs to treat the virus.

Some experts suggest omicron variant

Some experts suggest omicron variant may have evolved in an animal host

When COVID-19 variants arise, the accepted wisdom is that the constellation of mutations they contain developed in an immunocompromised person who contracted the virus and couldn’t shake the infection. But some scientists have an alternative theory for where the latest variant of concern, omicron, may have acquired the unusual mutations that stud its spike protein.

They speculate the virus could have evolved in another animal species.

The theory goes that some type of animal, potentially rodents, was infected with the SARS-CoV-2 virus sometime in mid-2020. In this new species, the virus evolved, accumulating roughly 50 mutations on the spike protein before spilling back over into people.

Kristian Andersen, an immunologist at the Scripps Research Institute, is among those who has been raising the idea that Omicron may have emerged from a reverse zoonotic event.

(A zoonotic event is when an animal pathogen starts to infect and spread among people. A reverse zoonosis is when such a virus passes back into an animal species.)

“I know that most people think that these [come from] immunocompromised individuals, and I do think that that’s plausible, but to be perfectly honest, I actually think this reverse zoonosis followed by new zoonosis seems more likely to me given just the available evidence of the really deep branch, and then the mutations themselves, because some of them are quite unusual,” Andersen told STAT.

  • “I don’t think we should dismiss that possibility, because I think it’s definitely on the table.”
  • A number of other scientists who study the evolution of viruses have told STAT they think the idea isn’t out of the question. Some place more weight on the theory that variants develop in immunocompromised people, while others feel there isn’t enough evidence at this point to favor one option over the other.
  • “Personally, I think it’s probably more likely it was circulating undetected, in an immunocompromised individual,” Emma Hodcroft, a molecular epidemiologist at the Institute of Social and Preventive Medicine in Bern, Switzerland, said via email. Having said that, though, Hodcroft insisted that it is important to explore the hypothesis.
  • “I would certainly consider it a plausible alternative hypothesis to the evolution during a persistent infection in a human,” said Andrew Rambaut, a professor of molecular evolution at the Institute of Evolutionary Biology in Edinburgh. He cautioned that coming up with a definitive answer won’t be quick.
  • “I am not sure we will be in a position to say for sure for a while,” Rambaut wrote in an email.

One of the peculiar traits of SARS-2 underpins this thinking. It is what virologists describe as a promiscuous virus; it is capable of infecting a number of species. Dogs and house cats. Large cats. MinkWhite-tailed deer. Given how easily the virus seems to jump from species to species, people studying it assume this list will grow.

The original virus that came out of Wuhan, China, in early 2020 did not infect rodents. But as variants — Alpha, Beta, Delta — started to emerge, those viruses could infect rodents.

Robert Garry, a professor of microbiology and immunology at Tulane Medical School, has been tracking the SARS-2 mutations that have arisen. Seven are associated with rodent adaptation — the changes that seemed to allow the virus to infect mice, rats, and related species. All seven of those mutations are in omicron, Garry noted. He believes it’s a toss-up whether the variant developed in an animal or a human host, but if it’s the former, his bet would be on rodents.

Getting a firm answer might require enormous luck. Scientists are looking at various animal species to see if they can be infected with SARS-2; were they to find viruses like omicron in any, that would swing the needle.

But Michael Worobey, a professor of evolutionary biology at the University of Arizona, thinks one could do some experiments on selected species of wild animals to see if they can be infected and if, when infected, similar patterns of viral evolution occur.

Studying the molecular clock of viruses that spread in animals — looking at the speed at which they evolve and comparing it to SARS-2 evolution in humans — could also provide some clues, said Worobey, who initially thought Andersen’s idea was not impossible, but not the likeliest of explanations for omicron. After hearing details of the explosive outbreak in white-tailed deer, he’s rethinking the idea.

For Worobey, the question is whether any animal species can become chronically infected with SARS-2 — in effect, whether there are animal species in which SARS-2 lingers in the way it does in immunocompromised people. That could put positive selective pressure on the virus — in other words give it an incentive to mutate to stay ahead of the animal’s immune response.

“It does move my thinking in terms of omicron possibly having come from a reservoir, if there are [animal] reservoirs that do chronic infections,” he said.

Part of what leads Andersen to wonder about an animal source is the fact that the variant traces back to viruses that were spreading over a year ago. “That in itself you need to be able to explain,” he said.

Angela Rasmussen, a coronavirus virologist at the University of Saskatchewan’s Vaccine and Infectious Disease Organization, agreed.

“I think it’s pretty obvious to everybody … that this virus has been on an independent evolutionary track for quite some time and it’s very surprising, which to me just kind of goes back to say well, the idea that this could be … plausible,” she said.

Regardless of whether this variant emerged in another species or not, given SARS-2’s ability to jump species, it is possible the world will face animal-derived variants in the future, Garry warned. The upshot of that? “We’re going to have to keep tweaking the vaccines.”

Worldwide Suppliers

Gentaur distributes Laboratory Research reagents from the folliwing sources

Lab suppliers


Aaron Medical Industries, Inc., subsidiary of Bovie Medical
Abbott Laborories – Product List
ABgene® (Advanced Biotechnologies Ltd.)
AbioMed, Inc.
Acambis plc
Access Pharmaceuticals, Inc.
AccuTech, LLC
Ackrad Laboratories, Inc.
ACMI [American Cystoscope Makers Inc.] Corporation, wholly owned subsidiary of Maxxim Medical
ACON Laboratories
Acorn Cardiovascular, Inc.
AcroMed Corporation (see DePuy AcroMed, Inc.)
Actelion Ltd. (Switzerland)
AcroMetrix Corporation
AcryMed Inc.
Acuson Corp.
Adams Laboratories
A-Dec, Inc.
ADM Tronics, Inc.
Adolor Corporation
Advanced Bionics
Advanced Biotechnologies Ltd. (a.k.a. ABgene®)
Advanced Bio-Technologies, Inc.
Advanced Magnetics, Inc.
Advanced Neuromodulation Systems, Inc.
Advanced Stent Technologies, Inc. (AST)
Advanced Surgical Concepts
Advanced Tissue Sciences
Advanced UroScience, Inc.
AEterna Laboratories Inc.
Afferon Corporation
Agilent Technologies
Agouron Pharmaceuticals, Inc.
Aircast, Inc.
Akorn Ophthalmics, Inc.
Akzo Nobel N.V.
Alaris Medical Systems, Inc. – Product information
Alcon Laboratories, Inc.
Alexion Pharmaceuticals
Alfacell Corporation
Allegiance Healthcare Corporation
Alliance Pharmaceutical Corp.
Alpharma Inc.
Alphatec Manufacturing, Inc.
Alteon, Inc.
Amarillo Biosciences
Amarin Pharmaceuticals, Inc.
AMDL, Inc.
A-Med® Systems, Inc.
American Dental Technologies, Inc.
American Home Products [AHP] (see Wyeth)
American Medical Systems (AMS), Inc.
Amgen, Inc.
Amylin Pharmaceuticals
Anamed Inc.
Andaris Ltd. (see Quadrant Healthcare)
Andrx Corp.
Andwin Scientific
Anergen, Inc. (see Corixa Corp.)
Anesta Corp.
AnorMED Inc. (Canada)
Antares Pharma AG (planned merger: Medi-Ject & three Permatec subsidiaries)
Antex Biologics Inc.
Antigenics, LLC
Apdyne Medical Company
Aphton Corporation
Applied Medical
Aradigm Corporation
Arco Medic, Ltd
Aronex Pharmaceuticals
Arris Pharmaceutical Corp. (see Axys Pharmaceuticals)
Arrow International, Inc.
ArteriA Medical Sciences, Inc.
Arthrex Inc.
ArthroCare Corp.
ASAC Pharmaceutical International, AIE
Ascension Orthopedics, Inc.
AstraZeneca PLC (U.S.) – Product List
Athena Neurosciences, Inc., wholly owned subsidiary of Elan Corporation
Atrium Medical Corporation
Atrix Laboratories Inc.
AutoCyte, Inc. (see TriPath Imaging)
AutoImmune, Inc.
Avanir Pharmaceuticals
Avant Immunotherapeutics, Inc.
AVAX Technologies, Inc.
Avecor Cardiovascular (see Medtronic® Perfusion Systems)
Aventis Behring, div. of Aventis S.A.
Aventis Pasteur, div. of Aventis S.A.
Aventis Pharmaceuticals (U.S.)
Aventis S.A.
AVI BioPharma
Avigen Inc.
Avitar, Inc.
Avocet Medical
Axcan Pharma, Inc.
Axcan Scandipharm, Inc.
Axonyx Inc.


Bacchus Vascular, Inc.
Bard Access Systems, div. of C. R. Bard
Bard Medical, div. of C. R. Bard
Barr Laboratories
BASF Pharma
Bausch & Lomb
Bausch & Lomb Surgical
Baxter International Inc.
Bayer AG
Bayer Diagnostics
BD (Becton, Dickinson and Company)
Bayer USA
Beckman Coulter
Beckman Instruments, Inc.
BEI Medical Systems (see Boston Scientific Corporation)
Berlex Laboratories, subsidiary of Schering AG
Binax, Inc.
BioEnterics, an Inamed company
Biofield Corp
Biogen, Inc.
Bioglan Pharma Inc.
Bioject Medical Technologies, Inc.
Biolase Technology, Inc.
Bio-logic Systems Corp.
Bio Med Sciences Inc.
Biomerica, Inc.
Biomet, Inc.
Biomira Inc.
Bioniche Life Sciences Inc.
Biopure Biopharmaceuticals
Biora AB
Biosense Webster, a Johnson & Johnson company
Biosound Esoate, Inc.
BioSpecifics Technologies Corp.
BioStar, Inc.
Biostar Inc. (Canada)
BioStratum Inc.
Biosyn, Inc.
Biota Holdings Ltd.
Bio-Technology General Corp. (BTGC)
Biotherapies Inc.
BioTime, Inc.
BioTransplant Incorporated
Biotronik Biomedical
Blansett Pharmacal Co., Inc.
Block Drug Company
Boehringer Ingelheim
Boehringer Mannheim (merger: see Roche)
Bone Care International
Bonutti Research
Boston Medical Technologies, Inc.
Boston Scientific
Bovie Medical
Bracco Diagnostics Inc.
Bradley Pharmaceuticals, Inc.
Braintree Laboratories, Inc.
Bristol-Myers Squibb
British Biotech
Bryan Corporation
Buckley – W.K. Buckley Ltd.
Byron Medical


Calypte Biomedical
Cantab Pharmaceuticals
Cambridge Heart, Inc.
CancerVax™ Corporation
Candela Corporation – Product list
Caraco Pharmaceutical Laboratories, Ltd.
Cardeon Corporation
Card Guard Scientific Survival Ltd. [Card Gard]
Cardiac Control Systems
Cardiac Pathways
Cardiac Science
Cardinal Health, Inc.
CardioGenesis Corp. (see Eclipse Surgical)
CardioMed Catalogue
Cardio Medical Solutions, Inc.
CardioTech International, Inc.
CardioVations, div. of Ethicon, Inc.
CardioThoracic Systems, Inc. (see Guidant Corporation)
Cares Built, Inc.
Carrington Laboratories
Celgene Corporation
Cellegy Pharmaceuticals, Inc. (being remodeled)
Cellestis Limited
Cell Genesys, Inc.
Cell Pathways, Inc.
Cell Robotics
Celltech Chiroscience
Celltech Medeva
Cell Therapeutics
CEL-SCI Corporation
CeNeS Pharmaceuticals
Centeon LLC (see Aventis Behring)
Centocor, Inc.
Cephalon, Inc.
Cerus Corporation
ChemTrak Inc. (see AccuTech, LLC)
Chiron Corporation
Chiron Vision (see Bausch & Lomb Surgical)
Chiroscience Group PLC (see Celltech Chiroscience)
CHAD Therapeutics
Chronimed Inc.
Ciba-Geigy AG (see Novartis)
CIBA Vision
CIBA Vision Ophthalmics (see Novartis Ophthalmics)
Cima Labs, Inc.
Circon Corp. (see ACMI Corporation [a.k.a. AMCI Circon], wholly owned subsidiary of Maxxim Medical)
Clarus Medical
Cleveland Medical Devices Inc.
Closure Medical
COBE BCT (see Gambro BCT)
COBE Cardiovascular, Inc., div. of Sorin Biomedica
CoCensys, Inc. (see Purdue Pharma L.P.)
Cochlear Corporation
Coherent, Inc. (see Lumenis)
Cohesion Technologies
Colin Medical Instruments
Collagen Aesthetics
CollaGenex Pharmaceuticals
Collateral Therapeutics, Inc.
ColorMax Technologies, Inc.
CompuCyte Corporation
Computerized Thermal Imaging, Inc.
Computer Motion
Conceptus Inc.
Confluent Surgical, Inc.
Connetics Corporation
Conway Stuart Medical [CSM], Inc. (see Curon Medical, Inc.)
Cook Group Incorporated
Cook Urological
CooperSurgical, div. of The Cooper Companies, Inc.
Copley Pharmaceutical, Inc. (see Teva USA a.k.a. Teva Pharmaceuticals USA)
Cordis Corporation, a Johnson & Johnson company
Cordis Webster (see Biosense Webster)
Core Dynamics, Products
Corixa Corporation
Corning Besselaar (see Covance, Inc.)
Corning Pharmaceutical Services (see Covance, Inc.)
Coronado Industries, Inc.
Corporate Technology Development, Inc.
Cortecs International
Cortex Pharmaceuticals, Inc.
Covance, Inc.
C. R. Bard
Creative BioMolecules [CBM] (see Curis, Inc.)
CryoCath Technologies
Cubist Pharmaceuticals, Inc.
Curative Health Services
Curis, Inc.
Curon Medical, Inc.
CV Therapeutics
Cypress Bioscience, Inc.
Cypress Pharmaceutical, Inc.
Cypros Pharmaceutical Corporation (see Questcor Pharmaceuticals, Inc.)
CytRx Corporation
Cytosol Ophthalmics Inc.
CytoTherapeutics (see StemCells, Inc.)
Cytyc Corporation
Cytogen Corporation


Dade Behring
Daiichi Pharmaceutical Co., Ltd.
Data Critical
Davol Inc., div. of C. R. Bard
Dendreon Corporation
Deltec – Product Catalog
Dental/Medical Diagnostic [DMD] Systems, Inc.
Dentsply International, Inc.
Denver® Biomedical
DepoMed, Inc.
DepoTech Corporation, wholly owned subsidiary of SkyePharma PLC
DePuy, Inc., a Johnson & Johnson company
DePuy AcroMed, Inc., a Johnson & Johnson company
Derma Sciences, Inc.
Dermik Laboratories
DeRoyal Industries, Inc.
DesChutes Medical Products, Inc.
Dexide (see U.S. Surgical)
Dexterity Surgical, Inc.
Dey, Inc.
Diagnostic Monitoring, div. of Advanced Biosensor
Diagnostic Products Corp. [DPC]
Diagnostic Ultrasound Corp.
Diametrics Medical
Diatide, Inc.
Digene Corp.
Digital Medical Systems
Dimethaid Research Inc.
DIPRO [Diagnostic Products Inc.] – DIPRO product listing
Discovery Laboratories, Inc.
dj Orthopedics [DonJoy]
DonJoy (see dj Orthopedics)
Doak Dermatologics, div. of Bradley Pharmaceuticals
Dornier Medical Systems, Inc.
Dovetail Technologies, Inc.
Dow Hickam Pharmaceuticals Inc. (see Bertek Pharmaceuticals Inc.)
Draximage Inc., subsidiary of Draxis Health Inc.
Draxis Health Inc.
Dumex Medical Surgical Products Ltd.
DuPont Merck Pharmaceuticals (see DuPont Pharmaceuticals, Inc. [DuPont Pharma])
DuPont Pharmaceuticals, Inc. [Dupont Pharma] (see Bristol-Myers Squibb)
Dura Pharmaceuticals, Inc.
Duramed Pharmaceuticals, Inc.
Durect Corporation
DUSA Pharmaceuticals
Dymedix Corp.
Dynamic Healthcare Technologies


Eagle Laboratories, Inc. Home Page
Eclipse Surgical
EDAP Technomed, Inc.
Edwards Lifesciences Corporation
EG&G Inc.
Elan Corporation
ELAST Technologies, Inc.
ElectroRegenesis Inc.
Elekta AB
Eli Lilly
E.M. Parker Co., Inc.
Embolic Protection, Inc., div. of Boston Scientific Corporation
Embryotech Laboratories, Inc.
Empi, Inc.
Encore Medical
Endicor Medical, Inc.
Endius Incorporated
Endo Pharmaceuticals Holdings, Inc. (merger: Endo Pharmaceuticals, Inc.; Algos Pharmaceuticals)
Endo Pharmaceuticals, Inc. (see Endo Pharmaceuticals Holdings, Inc.)
Endorex Corporation
Endovasc Ltd., Inc.
Enraf-Nonius, wholly owned subsidiary of Henley Healthcare Inc.
Enteron Pharmaceuticals, Inc., majority-owned subsidiary of Corporate Technology Development, Inc.
Entropin, Inc.
Enzon Inc.
Epitope, Inc.
Epix Medical, Inc.
Ergo Science Corporation
ESC Medical Systems Ltd. (see Lumenis)
ESC Sharplan (see Lumenis)
Ethicon, Inc., a Johnson & Johnson company
Ethex Corporation, subsidiary of KV Pharmaceutical Company
Evans Enterprise
Everest Medical Corporation
Eximas Pharmaceutical Corporation
Exocell, Inc.
E-Z-EM Inc.



Femcare Ltd. (UK)
FemRx Inc. (see Ethicon, Inc.)
Ferring Pharmaceuticals
Fielding Pharmaceutical Company
Fischer Imaging
Fleming & Company
FlexSite Diagnostics, Inc.
Florence Medical, Inc.
Focal, Inc.
FONAR Magnetic Resonance Imaging
Forbes Medi-Tech Inc.
Forest Laboratories, Inc.
Fougera® (E. Fougera & Co.)
Friatec Medical Technology (see Friadent)
Fujisawa Healthcare, Inc. (USA)
Furon Company (see Saint-Gobain Performance Plastics)
Fusion Medical Technologies
FzioMed Inc. (under construction)


Galen Holdings, plc.
Galderma Laboratories
Gambro AB
Gambro BCT, div. of Gambro AB
Gambro Renal Products, Inc., div. of Gambro AB
Gamma Biologicals, Inc.
G.D. Searle & Co., div. of Monsanto Company (see Pharmacia Corporation)
GelTex Pharmaceuticals, Inc.
GE Lunar, subsidiary of GE Medical Systems
GE Medical Systems
Genaissance Pharmaceuticals
Genelabs Technologies, Inc.
Genentech, Inc.
General Surgical Innovations, Inc. (see U.S. Surgical)
Generex Biotechnology Corporation
Genetics Institute
Genetronics Biomedical Ltd.
GenSci Regenerative Sciences Inc.
Gensia Sicor Inc. (see Sicor Inc.)
Gensia Sicor Pharmaceuticals, a subsidiary of Sicor Inc.
Genta Incorporated
Gentive Health Services
GenVec, Inc.
Genzyme Corporation – Products and Services
Gilead Sciences
Gillette’s Children’s Specialty Healthcare
Given Imaging Ltd.
GlaxoSmithKline [Gateway]
GlaxoSmithKline [U.S.]
Glaxo Wellcome (U.S.) (see GlaxoSmithKline)
Gliatech Inc.
Goodwin Biotechnology
Grams American Suture, Inc.
Guidant Corporation
Guilford Pharmaceuticals
G&W Laboratories, Inc. (800-922-1038)
Gynecare, div. of Ethicon, Inc.


Harvest Technologies Corp.
Harvard Scientific Corp. (775-323-6751)
Hawthorn Pharmaceuticals, div. of Cypress Pharmaceutical, Inc.
Hayes Medical, Inc.
Healthdyne Technologies (see Respironics, Inc.)
Health Hero Network
Healthpoint, Ltd.
HealthTronics, Inc.
Hearing Innovations Inc.
Heartstream, Inc. (see Agilent Technologies)
Helsinn Healthcare S.A.
Hemagen Diagnostics, Inc.
Hema Metrics
Hemispherx BioPharma, Inc.
Hemosol Inc.
HemoTherapies, Inc.
Henley Healthcare Inc.
Hewlett-Packard Medical Products Group (see Agilent Technologies)
Hill Dermaceuticals
Hitachi Medical Systems
Hoechst AG (see Aventis S.A.)
Hoechst Marion Roussel (see Aventis Pharmaceuticals [U.S.])
Hoffmann-La Roche, U.S. prescription drug unit of the Roche Group
Hollis Eden Pharmaceuticals
Hologic, Inc.
Home Access Health Corporation
HomMed LLC
Horizon Medical Products, Inc.
Horus Global HealthNet
Howmedica Osteonics, div. of Stryker Corporation
Human Genome Sciences, Inc.
Hutchinson Technology, Inc.
Hybridon Inc.
Hydrogiene Corporation (to be renamed Synergie Holdings Corporation)
HydroMed Sciences
Hypertension Diagnostics Inc.


IBEX Technologies
ICN Pharmaceuticals
ICOS Corporation
ID Biomedical Corporation
I-Flow Corporation
IGT Pharma (Canada)
ILEX Oncology, Inc.
Imaging Dynamics
Imagyn Medical Technologies Inc.
ImClone Systems, Inc.
Immune Response Corporation
Immunex Corporation (see Amgen, Inc.)
Immunomedics, Inc.
IMPAX Laboratories, Inc.
Impra, Inc., subsidiary of C.R. Bard
Imutec Pharma Inc. (see Lorus Therapeutics Inc.)
IMX Pharmaceuticals
Inamed Corporation
Incara Pharmaceuticals Corporation
Indigo Medical
Inex Pharmaceutical Corporation
Infinitech, Inc.
Influence Medical, Inc. (see American Medical Systems [AMS], Inc.)
Infusion Dynamics, Inc.
Inhale Therapeutic Systems, Inc.
InKine Pharmaceutical Company, Inc.
Inlet Medical
In-Line Diagnostics Corporation
Promega Corporation
InnerDyne Inc.
Innomed Technologies Inc.
Innovative Tracking Solutions (being remodeled)
Instromedix®, div. of Alaris Medical Systems, Inc.
Instrumentarium Imaging Inc.
Instrumentation Laboratory Company\
Instrument Makar, Inc. (acquired 2/27/02 by Smith & Nephew Endoscopy)
Integra LifeSciences Corporation
Integra NeuroSciences, div. Integra LifeSciences Corporation
Intercardia, Inc. (see Incara Pharmaceuticals Corporation)
Interferon Sciences, Inc.
InterMune Pharmaceuticals, Inc.
International Medical Innovations, Inc. (IMI)
International Murex Technologies Corporation (see Abbott Laboratories)
Interneuron Pharmaceuticals, Inc.
Interpore Cross International
Interventional Technologies
Intracel Corporation
IntraEAR, div. of Durect Corporation
IntraTherapeutics, Inc.
Intuitive Surgical
Inverness Medical Technology
Iridex Corp.
Irvine Biomedical, Inc.
Ischemia Technologies
Isis Pharmaceuticals
Itamar Medical Ltd.
Isomedix, Inc. (see Steris Corporation)
IVAC Medical Systems [IVAC] (see Alaris Medical Systems, Inc.)
IVAX Corporation
IVP Pharmaceutical Care, Inc., d.b.a. ivpcare


Jacobson Resonance Enterprises, Inc.
Janssen Pharmaceutica
Johnson & Johnson
Johnson & Johnson Gateway


Kaire Nutraceuticals
Karl Storz
The Kendall Company, L.P.
Kensey Nash Corporation
Kerr, a div. of Sybron Dental Specialties, Inc.
Keryx Biopharmaceuticals, Inc.
Kinesis Medical, Inc. (to be acquired by Orthofix, Inc.)
Kinetic Concepts, Inc. [KCI]
King Pharmaceuticals, Inc.
Knoll AG/BASF Pharma
Knoll Pharmaceutical Company, U.S. subsidiary of Knoll AG/BASF Pharma
Konan Medical Inc. (Japan)
Konsyl Pharmaceuticals Inc.
Kos Pharmaceuticals Inc.
KV Pharmaceutical Company


LAM Pharmaceutical Corp.
Landec Technologies
La Jolla Diagnostics Inc. (see NatureWell, Inc.)
Lane Labs, Inc.
Lancer Orthodontics
LaserSight Technologies, Inc.
Layton BioScience, Inc.
Laser Industries Ltd./Sharplan Lasers Inc. (see ESC Sharplan)
LeukoSite, Inc. (see Millennium Pharmaceuticals, Inc.)
Lidak Pharmaceuticals (see Avanir Pharmaceuticals)
LifeCell Corporation
Lifecore Biomedical, Inc.
LifeLine BioTechnologies, Inc.
Life Medical Sciences Inc.
Life Plus® International
LifeQuest Medical, Inc. (see Dexterity Surgical, Inc.)
Lifescan, a Johnson & Johnson company
LifeSleep Systems
Lifestream Technologies
Ligand Pharmaceuticals
LMA North America, Inc., subsidiary of Laryngeal Mask Company Ltd.
LMS Medical Systems Limited
Lone Star Medical Products
Longport Inc.
LORAD, div. of Hologic, Inc.
Lorus Therapeutics Inc.
Lunar Corporation (see GE Lunar)
Luxar, subsidiary of ESC Medical Systems Ltd./ESC Sharplan
LXR Biotechnology Inc.


MacroChem Corporation
MacroMed, Inc.
MacroPore, Inc.
Magainin Pharmaceuticals Inc.
Makoff R&D Laboratories Inc. (see Watson Pharmaceuticals, Inc.)
• Imaging Group
• Pharmaceuticals Group
• Respiratory Group
Mallinckrodt Sensor Systems, Inc. (see Instrumentation Laboratory Company)
Masimo Corporation
Matrix Pharmaceuticals
Maxim Pharmaceuticals
Maxxim Medical
McGhan Medical Corporation, an Inamed company
McNeil Consumer Healthcare (see Johnson & Johnson)
MD Systems, Inc.
MD Tech™ (Medical Device Technologies Inc.)
Mead Johnson Nutritionals, div. of Bristol-Myers Squibb
Medarex, Inc.
MedCam Technology, Inc.
Medco Research, Inc. (see King Pharmaceuticals, Inc.)
Med-Design Corporation
Medeva PLC (see Celltech Medeva)
Medex, div. of Saint-Gobain Performance Plastics
MedicalCV, Inc.
Medical Device Technologies Inc. (a.k.a. MD Tech™)
Medical Diagnostic Laboratories
Medical Dynamics
Medicis Pharmaceutical Corp.
Medi-Flex Hospital Products, Inc.
MediGene AG
MedImmune, Inc.
Medisan Pharmaceuticals (see BioPhausia)
Medispec Ltd.
Medisys Technologies Inc.
MedLogic Global Corporation
Medrad, Inc.
MedSlant, LLC
Medtox Scientific, Inc.
Medtronic® Perfusion Systems
MEHL/Biophile International Corp. (508-481-9495)
Mentor Corporation
Merck & Co., Inc.
Merit Medical Systems
Merz + Co.
Metabolic Technologies Inc. [MTI BioTech]
Metabolic Solutions, Inc.
Metra Biosystems, Inc. (see Quidel Corporation)
Metrika Inc.
MGI Pharma, Inc.
Micromedics (USA) Inc.
MicroMed Technology, Inc.
MicroMedical Industries
Micro Therapeutics, Inc.
Milestone Scientific Inc.
Millennium Dental Technologies
Millennium Pharmaceuticals, Inc.
Miravant Medical Technologies
Misonix, Inc.
Monarch Pharmaceuticals, wholly owned subsidiary of King Pharmaceuticals, Inc.
MTD Inc.
Mova Pharmaceutical Corporation
Muro Pharmaceutical, Inc.
Murray Electronics
MW Medical
Mylan Laboratories Inc.
Myriad Genetics, Inc.


Nastech Pharmaceutical Company Inc.
National Genetics Institute
NatureWell Inc.
Natural Science Corporation
NAVION™ Biomedical
NeedleAid Ltd.
Nellcor Puritan-Bennett (see Mallinckrodt Respiratory Group)
NeoPath Inc. (see TriPath Imaging)
NeoRx Corporation
NeoTherapeutics, Inc.
Neotonus, Inc.
Network Concepts, Inc.
Neurex Corporation (see Elan Corporation)
Neurobiological Technologies, Inc.
Neurochem Inc.
NeuroMotion Inc.
Neuron Therapeutics, Inc.
NeuroVasx, Inc.
Nexell Therapeutics, Inc.
NeXstar Pharmaceuticals, Inc. (see Gilead Sciences, Inc.)
Niche Pharmaceuticals
Nycomed Amersham Imaging (see Amersham Health)
Nitinol Medical Technologies, Inc. (see NMT Medical, Inc.)
NMT Medical, Inc.
Norland Medical Systems, Inc.
North American Scientific, Inc.
North American Vaccine, Inc.
Northern Research Laboratories
Northfield Laboratories
Northrop Grumman
Novacept, Inc.
Nova Factor Inc.
NovaMed Inc.
Novartis Ophthalmics (U.S.)
Novartis Pharmaceuticals
Novartis Pharmaceuticals (U.S. site)
Novavax, Inc.
Noven Pharmaceuticals, Inc.
Novitron International
Novogen Limited
Novogyne Pharmaceuticals
Novo Nordisk
Novopharm USA (see Teva USA a.k.a. Teva Pharmaceutical USA)
Novoste Corp.
NPS Pharmaceuticals
Nucletron BV
Nutrica USA
Nutricept, Inc.
Nycomed Amersham (U.K.; corporate)
Nycomed Amersham (U.S.)


Obagi Medical Products
Oculex Pharmaceuticals
(Datex) Ohmeda
Olympus America, Inc.
Omron Healthcare, Inc.
Oncor Inc.
Onux Medical, Inc.
Ophthalmic Imaging Systems, Inc.
Optical Sensors Incorporated
Optima Worldwide, Ltd.
Optimize, Inc.
Optivus Technology, Inc.
Optomedic Medical Technologies
Oratec Interventions, Inc.
Oravax, Inc., a subsidiary of Peptide Therapeutics Group (see Acambis plc)
Orbus Medical Technologies
O.R. Direct
Organogenesis, Inc.
Organon Inc.
Organon Teknika (see bioMérieux, Inc.)
Oridion Systems, Ltd.
Orion Pharma
Orphan Medical
Orphan Pharmaceuticals USA
Ortec International, Inc.
Ortho Development Corporation
Ortho-McNeil Pharmaceutical, Inc.
Orthopaedic Biosystems Ltd. (OBL), Inc.
Orthosoft Inc.
OSI Pharmaceuticals
Osiris Therapeutics, Inc.
Osteonics (see Howmedica Osteonics, div. of Stryker Corporation)
Otsuka America Pharmaceutical, Inc.
Oxford BioMedica plc
Oxford GlycoSciences
Oxigene, Inc.
OXO Chemie AG
Ozelle Pharmaceuticals, Inc.


Pacesetter, Inc.
Pacific Pharmaceuticals Inc.
Pacific Surgical Innovations, Inc.
Packard BioScience Company
Paddock Laboratories, Inc.
Pain Therapeutics, Inc.
Palatin Technologies, Inc.
Palco Laboratories
Pall Corporation
Palomar Medical Technologies, Inc.
Pan Americal Laboratories, Inc. (Pamlab®)
Paradigm Medical Industries, Inc.
Parke-Davis, div. of Warner Lambert (see Pfizer Inc.)
Pasteur Mérieux Connaught (see Aventis Pasteur)
PathoGenesis Corp. (to be acquired by Chiron Corporation)
PBN Medicals
Penederm, Inc. (see Bertek Pharmaceuticals, Inc.)
Peptide Therapeutics Group (see Acambis plc)
Perclose, Inc.
PercuSurge, Inc.(see Medtronic)
Peregrine Pharmaceuticals, Inc. (formerly Techniclone Corporation)
PerImmune (see Intracel Corporation)
Pfizer 1995 Annual Report
Pharmacia and Upjohn (see Pharmacia Corp.)
Pharmacia Corp.
Pharmacyclics, Inc.
Pharmaton Natural Health Products
Pharmos Corporation
Pheromone Sciences Corp.
Physio-Control Corp.
Physiometrix, Inc.
Picker International, Inc.
Plainview LLC
Point of Care Technologies
Polydex Pharmaceuticals Ltd.
Polymedco, Inc.
Polymer Technology Systems
Praecis Pharmaceuticals
Precision Instruments
Precision Vascular, Inc.
Premier Laser Systems
Presby Corp.
Procter & Gamble Pharmaceuticals
Procyon BioPharma
ProCyte Corporation
Progenics Pharmaceuticals
Prographarm Group
Protherics PLC
Promega Corporation
Prometheus Labs
Prosurg, Inc.
Protarga, Inc.
Protein Design Labs, Inc.
Protein Polymer Technologies, Inc.
Provalis plc
Proxima Therapeutics, Inc.
Purdue Pharma L.P.
Pyng Technologies


QLT, Inc.
QLT PhotoTherapeutics (see QLT, Inc.)
Q-Med Laboratories
QRS Diagnostic, LLC
Quadrant Healthcare plc.
Quantech Ltd.
Quest Medical, Inc.
Questcor Pharmaceuticals, Inc.
Quidel Corporation


R&D Laboratories Inc./Makoff R&D Laboratories (see Watson Pharmaceuticals, Inc.)
Radiance Medical Systems, Inc.
Radiancy, Inc.
Radiant Medical, Inc.
Radionics Online
Ramus Medical Technologies
RayMedica, Inc.
R&D Laboratories, Inc.
Reckitt & Colman Inc.
Refractec, Inc.
Regam Medical Systems International
Regeneron Pharmaceuticals, Inc.
Reliant Technologies, Inc.
RenalTech™ International
Reprogenesis, Inc. (see Curis, Inc.)
Respironics, Inc.
Rexall Sundown, Inc.
Rhone-Poulenc S.A. (see Aventis S.A.)
Rhone-Poulenc Rorer (see Aventis Pharmaceuticals (US))
Rhythm Technologies Inc.
Ribozyme Pharmaceuticals Inc. (RPI)
R-Med, Inc./Products
Roberts Pharmaceutical Corporation (see Shire Pharmaceuticals Group)
Roche Laboratories
Roche Laboratories (USA)
Rochester Medical Corporation
Romark Laboratories
Ross Products, div. of Abbott Laboratories
Rossmax International Ltd
Roxane Laboratories, Inc
R.P. Scherer Corporation, a Cardinal Health company
Rusch Inc.
R. W. Johnson Pharmaceutical Research Institute


Sabratek Corp.
Saint-Gobain Performance Plastics
Samaritan Pharmaceuticals
Sanarus Medical, Inc.
Sandoz Ltd. (see Novartis)
Sankyo Company, Ltd.
Sankyo Parke Davis
San-Mar Laboratories, Inc.
Sanofi-Synthelabo Inc.
Santa Barbara Medco, Inc.
Santen Inc., a subsidiary of Santen Pharmaceutical Co., Ltd. (Japan)
Savage Laboratories, a division of Altana Inc.
Scandipharm, Inc. (see Axcan Scandipharm, Inc.)
Schein Pharmaceutical, Inc. (see Watson Pharmaceuticals, Inc.)
Schering-Plough Research Institute
Schick Technologies
Schwarz Pharma
Schwarz Pharma (USA)
SciClone Pharmaceuticals, Inc.
SCIMED Life Systems, Inc.
Scios Inc.
Sciton, Inc.
Searle (see Pharmacia Corporation)
Sicor Inc.
Select Medical Systems, Inc.
Senetek PLC
Sequus Pharmaceuticals, Inc. (see Alza Corporation)
Seradyn, Inc.
Serono Laboratories, Inc. (U.S.)
Serral, S.A. de C.V.
Shaman Pharmaceuticals/Shaman Botanicals
Sharplan Lasers Inc. (see ESC Sharplan)
Sherwood-Davis & Geck
Shire Pharmaceuticals Group plc (U.K.)
Siemens Medical Systems, Inc. USA
Siemens Nuclear Medicine
Sigma-Tau Pharmaceuticals, Inc
SIMS Deltec, Inc. (a.k.a. Deltec)
SIRTeX Medical
Situs Corporation
SkyePharma plc
SleepNet Corporation
SmithKline Beecham (U.S.) (see GlaxoSmithKline [U.S.])
Smith & Nephew
Smith & Nephew Wound Management Division (U.S.)
Sofamor Danek Group, Inc.
SOLA Optical/USA
Solvay Pharmaceuticals, Inc.
Somerset Pharmaceuticals
Somnus Medical Technologies
Sonus Pharmaceuticals, Inc.
SpaceLabs Medical
Sparta Pharmaceuticals, Inc. (see SuperGen, Inc.)
Speciality UltraVision
SpectRx, Inc.
Spenco Medical Corporation
The Spineology Group
Spire Biomedical, Inc., div. of Spire Corporation
St. Croix Medical
St. Jude Medical
STAAR Surgical
STC Technologies
StemCells, Inc.
Steris Corporation
Sterling Diagnostic Imaging
Sterling Medivations, Inc. (see SpectRx, Inc.)
Steroidogenesis Inhibitors International, Inc. (see Samaritan Pharmaceuticals)
Stöckert Instrumente GmbH, div. of Sorin Biomedica
Storz Instrument (see Bausch & Lomb Surgical)
Stryker Corp.
Sulzer Intermedics (see Guidant Corporation)
Sulzer Medica
Sulzer Orthopedics
Sulzer Spine-Tech
Summit Autonomous
Summit Technologies
Sunlight Medical
Sunrise Technologies, Inc.
SuperGen, Inc.
Surgical Dynamics
Surgical Sense, Inc. (see Davol, Inc.)
SurgiLight Inc.
Surgin Inc.
Surgi-Vision, Inc.
SwissRay International Inc.
Sybron Dental Specialties, Inc.
Synthon Pharmaceuticals, Ltd.
Symphonix Devices, Inc.
SynSorb Biotech


Takeda Pharmaceuticals America, Inc.
TAP Holdings (see TAP Pharmaceutical Products, Inc.)
TAP Pharmaceutical Products, Inc.
Taro Pharmaceuticals, Inc.
Technical Chemicals & Products, Inc.
Techniclone Corporation (see Peregrine Pharmaceuticals, Inc.)
TEI Biosciences Inc.
Teva Pharmaceutical Industries Ltd.
Teva Pharmaceuticals USA
Texas Biotechnology
TFX Medical
The Gillette Company
The Liposome Company, wholly owned subsidiary of Elan Corporation
The Medicines Company
Theken Surgical
TheraCom, Inc.
Therapeutic Antibodies (TAb®) Inc. (see Protherics PLC)
TheraSense, Inc.
Therion Biologics
Thermo BioAnalysis Corporation
Thermo Cardiosystems
ThermoLase Corporation
ThermaTrex Corporation
Ther-Rx Corporation, a subsidiary of KV Pharmaceutical Company
Theseus Imaging Corp. (to be acquired by North American Scientific, Inc.)
Thoratec Laboratories
Tianrong (TNRG)
Tishcon Corporation
Tissue Science Laboratories, PLC
Titan Pharmaceuticals Inc.
TMJ Concepts
TNRG (Tianrong)
3M Pharmaceuticals
Tokuyama America (under construction)
Toshiba America Medical Systems
Transkaryotic Therapies, Inc.
TransVascular, Inc.
Triangle Pharmaceuticals, Inc.
Tri-Ject International Corp.
Trimeris, Inc.
Tri-Med Specialties, Inc., subsidiary of Kimberly-Clark Corporation
Trinity Biotech
TriPath Imaging
Trylon Corp.
Tulip Company Home Page
Tutogen Medical, Inc.


UCB Pharma
UltraTouch Corporation
(Speciality) UltraVision
Unicare Biomedical, Inc.
Unimed Pharmaceuticals
United Therapeutics Corp.
Universal Medical Systems
Upsher-Smith Laboratories
Uroplasty, Inc.
UroSurge, Inc
US Bioscience Inc.
USMS, Inc.
U.S. Pharmaceutical Corporation
U.S. Surgical (United States Surgical Corporation), a Tyco Healthcare company


Valleylab, Inc.
Varian Associates Inc.
Vascular Architects
Vascular Solutions, Inc.
Vascular Therapeutics, Inc.
Vasomedical, Inc.
Venritex, Inc. (see St. Jude Medical [SJM])
Veos plc.
Versicor, Inc.
Vertex Pharmaceuticals
Vical Incorporated
VidaMed TUNA Procedure
VIMRX Pharmaceuticals (see Nexell Therapeutics, Inc.)
Vion Pharmaceuticals, Inc.
ViroPharma Inc.
Vista Medical Technologies
VISX Buyers Page
Vital Images, Inc.
Vitro Diagnostics, Inc.
Vysis, Inc.


W.K. Buckley Ltd.
Wallace Laboratories, div. of Carter-Wallace
Walter Lorenz Surgical, Inc.
Warner Chilcott, plc., wholly owned subsidiary of Galen Holdings, plc.
Warner-Lambert (see Pfizer Inc.)
Watson Pharmaceuticals, Inc.
Welch Allyn, Inc.
(The) Westaim Corp.
Weston Medical Group
Westwood-Squibb Pharmaceuticals (under construction)
Whitehall-Robins Healthcare (see Wyeth Consumer Healthcare)
W. L. Gore
Wolf Industries, Inc.
World Heart Corporation
Worldwide Medical Corp.
Wright Medical Technology, Inc.
Wyeth Consumer Healthcare
Wyeth Pharmaceuticals
Wyndgate Technologies, div. of Global Med Technologies


Xillix Technologies Corporation
Xomed Surgical Products


YM BioSciences, Inc.
York Medical, Inc. (see YM BioSciences, Inc.)


Zanfel Laboratories
Zarix, Inc. ( (see “http://www.eximiaspharm.com/”>Eximas Pharmaceutical Corporation)
Zeneca Group PLC (see AstraZeneca PLC)
Zenith Medical, Inc.
Zila Pharmaceuticals, Inc.
Zonagen Inc.
ZymeTx Inc.

Microplate based CLIA and magnetic particles

The In vitro diagnostic products POCT(Point of Care Test), Microbiology and Biochemistry are ISO9001 and EN ISO13485 CE certrified.

SARS-CoV-2 CLIA Microparticles


  1. Anti-SARS-CoV-2 RBD
  2. SARS-CoV-2 Neutralization Antibody (Qualitative)
  3. SARS-CoV-2 NAb Q (Quantitative)
  4. SARS-CoV-2 IgA
  5. CMU0402 SARS-CoV-2 IgM Ⅱ 100T/kit
  6. CMU0302 SARS-CoV-2 IgG Ⅱ 100T/kit


  1. E1701 SARS-CoV-2 IgM 96T/kit
  2. E1601 SARS-CoV-2 IgG 96T/kit
  3. E1501 Anti-SARS-CoV-2 RBD 96T/kit
  4. E1401 SARS-CoV-2 NAb 96T/kit

Rapid Test (Colloidal Gold)


  1. Anti-SARS-CoV-2
  2. SARS-CoV-2 Ag
  3. Anti-SARS-CoV-2 RBD
  4. SARS-CoV-2 IgA
  5. SARS-CoV-2 NAb
  6. Influenza/SARS-CoV-2 Ag Combo

Biochemistry Markers CLIA

  1. AFP
  2. CEA
  3. tPSA
  4. CA50
  5. fPSA
  6. CA125
  7. CA15-3
  8. CA19-9
  9. Ferritin
  10. ¤32-Microglobulin
  11. NSE
  12. CYFRA 21-1
  13. SCCA
  14. CA72-4
  15. Tumor Markers
  16. CMC0602
  17. CMC0702
  18. CMC1002
  19. CMC1102
  20. CMJ0102
  21. Anti-HCV
  22. HAV IgM
  23. HEV IgM
  24. HEV IgG
  25. Anti-HIV


  • CMJ0202 Anti-TP 100T
  • CMJ0103 HIV Ag/Ab Combo 100T

Infectious Diseases

  1. Hypertension
  2. Aldosterone
  3. ACTH
  4. Cortisol
  5. Renin
  6. Angiotensin II

Autobio CLIA Microparticles Product List

Bone Metabolism

  1. Osteocalcin
  2. Calcitonin
  3. Pepsinogen I
  4. Pepsinogen II
  5. T3
  6. T4
  7. TSH
  8. FT3
  9. FT4
  10. Anti-TG
  11. Anti-TPO
  12. TG
  13. PTH
  14. rT3*
  15. Thyroid
  16. HBsAg
  17. Anti-HBs
  18. HBeAg
  19. Anti-HBe
  20. Anti-HBc
  21. HBV PreS1-Ag
  22. Anti-HBc IgM
  23. Endocrine Hormone
  24. LH
  25. FSH
  26. PRL
  27. Testosterone
  28. E2
  29. PRG
  30. DHEA-S
  31. SHBG
  32. 17α-OHP
  33. AMH
  34. TORCH
  35. Toxo IgM
  36. CMV IgM
  37. Rubella IgM
  38. HSV-1 IgM
  39. HSV-2 IgM
  40. Toxo IgG
  41. CMV IgG
  42. Rubella IgG
  43. HSV-1 IgG
  44. HSV-2 IgG
  45. Chemiluminisent Substrate
  46. Diluent Universal
  47. System Wash
  48. Sample Cup
  49. Reaction Vessel
  50. Pre-natal
  51. Free ¤-HCG
  52. P–AFP
  53. ¤- HCG
  54. uE3
  55. PAPP-A
  56. MYO
  57. cTnI
  58. CK-MB
  59. NT-proBNP
  60. BNP*
  61. HS-cTnI*
  62. Diabetes
  63. CMG0102
  64. CMG0202
  65. Insulin
  66. C-Peptide
  67. IGF-1
  68. HGH
  69. Growth Hormone
  70. Hepato Fibrosis
  71. PIIINP
  72. Col 5
  73. LN
  74. HA
  75. CG*

Inflammation Monitoring

CMR0102 hs-CRP 100T

Coming Soon

Anemia CMS0302 Vitamin B12 100T Anemia CL0212-2 Ferritin 96T 96T 96T 96T 96T Hepato Fibrosis CL0315-2 CL0316-2 CL0317-2 CL0318-2 HA LN PⅢ Col Ⅳ CLIA Microplate Autobio Product List Thyroid 96T 96T 96T 96T 96T 96T 96T T3 T4 TSH FT3 FT4 Anti-TG Anti-TPO CL1001-2 CL1002-2 CL1003-2 CL1004-2 CL1005-2 CL1006-2 CL1007-2 96T 96T 96T 96T 96T 96T 96T 96T HBsAg Anti-HBs HBeAg Anti-HBe Anti-HBc Anti-HIV Anti-HCV Anti-TP CL0310-2 CL0311-2 CL0312-2 CL0313-2 CL0314-2 CLK0101 CLK0201 CLK0301 Tumor Markers 96T 96T 96T 96T 96T 96T 96T 96T AFP CEA tPSA CA50 fPSA CA125 CA15-3 CA19-9 CL0203-2 CL0205-2 CL0206-2 CL0207-2 CL0208-2 CL0209-2 CL0210-2 CL0211-2 ELISA Infectious Diseases HAV IgM HBsAg ELISA Version 1 HBsAg (High Sensitivity 0.1IU) HBsAg (High Sensitivity 0.1IU) Anti-HBs HBeAg Anti-HBe Anti-HBc Anti-HIV Anti-HTLV I&II ELISA 96T 96T 96T 192T 96T 96T 96T 96T 96T 96T E0314 E0315 EC0203 EC0207 E0316 E0317 E0318 E0319 E0321 E1303 Thyroid 96T 96T 96T 96T 96T T3 T4 TSH FT3 FT4 E1001 E1002 E1003 E1004 E1005 Tumor Markers EB04 EB05 EB01 E0203-2 E0205-2 E0106-2 96T 96T 96T 96T 96T 96T EBV EA-IgG EBV VCA-IgA EBV NA1-IgA AFP CEA HCG TORCH 96T 96T 96T 96T 96T 96T 96T 96T 96T 96T Toxo IgM CMV IgM Rubella IgM HSV-1 IgM HSV-2 IgM Toxo IgG CMV IgG Rubella IgG HSV-1 IgG HSV-2 IgG E0901 E0902 E0903 E0904 E0905 E0906 E0907 E0908 E0909 E0910 Autobio Product List Infectious Diseases 04 05 Microbiology Autobio Product List MC0304 Aerobic Culture Bottle SA 20T/Standard Aerobic MC0305 Aerobic Culture Bottle SP 20T/Standard Pediatric MC0306 Anaerobic Culture Bottle SN 20T/Standard Anaerobic MC0401 Mycobacterial Culture Bottle 20T Chlamydia Trachomatis Mycoplasma (UU-MH) Mycoplasma IES Mycoplasma TIES 25T 20T 20T 20T B0102 M0204 M0205 M0206 MA06 Mycoplasma IES Plus 30T M0602 Anaerobic Blood Culture Bottle 20T M0601 Bi-state Blood Culture Bottle 20T MC0301 MC0302 MC0303 Aerobic Culture Bottle FA Anaerobic Culture Bottle FN Aerobic Culture Bottle PF 20T/Resin Aerobic 20T/Resin Anaerobic 20T/Resin Pediatric Amikacin Amoxicillin and clavulanic acid Ampicillin Aztreonam Oxacillin Voriconazole Fluconazole Erythromycin Ciprofloxacin Caspofungin Clindamycin Linezolid Amphotericin B Chloromycetin ME01 ME02 ME03 ME04 ME05 ME06 ME07 ME08 ME09 ME10 ME11 ME12 ME13 ME14 256-0.016 256-0.016 256-0.016 256-0.016 256-0.016 32-0.002 256-0.016 256-0.016 32-0.002 32-0.002 256-0.016 256-0.016 32-0.002 256-0.016 Susceptibility Test Strip ME15 ME16 ME17 ME18 ME19 Meropenem Norfloxacin Penicillin Gentamicin Tetracycline 32-0.002 256-0.016 32-0.002 256-0.016 256-0.016 ME20 Cefuroxime 256-0.016 ME21 ME22 ME23 ME24 ME25 Cefoperazone sulbactam Ceftriaxone Ceftazidine Cefazolin Vancomycin 256-0.016 32-0.002 256-0.016 256-0.016 256-0.016 ME26 Imipenem 32-0.002 ME27 Itraconazole 32-0.002 ME28 Levofloxacin 32-0.002 ME29 Azithromycin 256-0.016 ME30 Ampicillin-Sulbactam 256-0.016 ME31 Polymyxin B 256-0.016 ME32 Trimethoprim-sulfamethoxazole 32-0.002 ME33 Metronidazole 256-0.016 ME34 Rifampicin 32-0.002 ME35 Minocycline 256-0.016 ME36 Piperacillin 256-0.016 ME37 Piperacillin-tazobactam 256-0.016 ME38 Tigecycline 256-0.016 Teicoplanin Cefepime Cefoperazone ME39 ME40 ME41 256-0.016 256-0.016 256-0.016 ME42 Cefotaxime 256-0.016 ME43 ME44 Cefoxitin Ofloxacin 256-0.016 256-0.016 Instruments Autobio Product List Endocrine Control II Endocrine Control II Level 1 Endocrine Control II Level 2 Endocrine Control II Level 3 ZKE0101 ZKE0201 ZKE0301 63.0 mL

Lieven Gevaert Bio-ir.

AutoLumo A2000 PLUS

  1. BC120
  2. Automated Blood Culture System
  3. Autof MS1000 Maldi Tof
  4. LUmo Microplate Luminometer
  5. PHOmo Microplate Reader
  6. iWO Microplate Washer (96-way manifold 8/12 wells per strip)
  7. iWO-960 Microplate Washer (96-way manifold 8/12 wells per strip)
  8. AutoMimo 1200
  9. Automated Sample Preparation System

Automatic Chemiluminescence Immunoassay Analyzer

Panbio Abbott Covid test

Panbio Abbott Covid test

About the Test


The Coronavirus disease (COVID-19) is an infectious disease caused
by a newly discovered coronavirus.

Other Microorganism
Staphylococcus aureus 1.0 X 106.0 CFU/ml No cross reaction
2 Staphylococcus saprophyticus 1.0 X 106.0 CFU/ml No cross reaction
3 Neisseria sp.(Neisseria lactamica) 1.0 X 106.0 CFU/ml No cross reaction
4 Escherichia coli 1.0 X 106.0 CFU/ml No cross reaction
5 Staphylococcus haemolyticus 1.0 X 106.0 CFU/ml No cross reaction
6 Streptococcus pyogenes 1.0 X 106.0 CFU/ml No cross reaction
7 Streptococcus salivarius 1.0 X 106.0 CFU/ml No cross reaction
8 Hemophilus parahaemolyticus 1.0 X 106.0 CFU/ml No cross reaction
9 Proteus vulgaris 1.0 X 106.0 CFU/ml No cross reaction
10 Moraxella catarrhalis 1.0 X 106.0 CFU/ml No cross reaction
11 Klebsiella pneumoniae 1.0 X 106.0 CFU/ml No cross reaction
12 Fusobacterium necrophorum 1.0 X 106.0 CFU/ml No cross reaction

Interfering Substances

The following 28 potentially interfering substances have no impact on Panbio™ COVID-19 Ag Rapid Test Device. The final test
concentrations of the interfering substances are documented in the Table below.

Endogenous Substance

  • Mucin 0.5% No Interferenc
  • 2 Hemoglobin 100 mg/L No Interference
  • 3 Triglycerides 1.5 mg/L No Interference
  • 4 Icteric (Bilirubin) 40 mg/dL No Interference
  • 5 Rheumatoid factor 200 IU/ml No Interference
  • 6 Anti-nuclear antibody >1:40 No Interference
  • 7 Pregnant 10-fold dilution No Interference

Exogenous Substance

  • Guaiacol glyceryl ether 1 μg/ml No Interference
  • 9 Albuterol 0.005 mg/dL No Interference
  • 10 Ephedrine 0.1 mg/ml No Interference
  • 11 Chlorpheniramine 0.08 mg/dL No Interference
  • 12 Diphenhydramine 0.08 mg/dL No Interference
  • 13 Ribavirin 26.7 μg /ml No Interference
  • 14 Oseltamivir 0.04 mg/dL No Interference
  • 15 Zanamivir 17.3 μg /ml No Interference
  • 16 Phenylephrine hydrochloride 15% v/v No Interference
  • 17 Oxymetazolin hydrochloride 15% v/v No Interference
  • 18 Amoxicillin 5.4 mg/dL No Interference
  • 19 Acetylsalicylic acid 3 mg/dL No Interference
  • 20 Ibuprofen 21.9 mg/dL No Interference
  • 21 Chlorothiazide 2.7 mg/dL No Interference
  • 22 Indapamide 140 ng/ml No Interference
  • 23 Glimepiride (Sulfonylureas) 0.164 mg/dL No Interference
  • 24 Acarbose 0.03 mg/dL No Interference
  • 25 Ivermectin 4.4 mg/L No Interference
  • 26 Lopinavir 16.4 μg/L No Interference
  • 27 Ritonavir 16.4 μg/L No Interference
  • 28 Chloroquine phosphate 0.99 mg/L No Interference

Repeatability & Reproducibility

Repeatability & Reproducibility of Panbio™ COVID-19 Ag Rapid Test Device was established using in-house reference panels containing
negative specimens and a range of positive specimens. There were no differences observed within-run, between-run, between-lots,
between-sites, and between-days.

  1. Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. J
    Autoimmun. 2020; Feb 26:102433. doi: 10.1016/j.jaut.2020.102433.
  2. Guo YR, Cao QD, Hong ZS, et al. The origin, transmission and clinical therapies on coronavirus disease 2019 (COVID-19)
    outbreak-an update on the status. Mil Med Res. 2020; Mar 13; 7(1):11.doi:10.1186/s40779-020-00240-0.
  3. Lai CC, Shih TP, Ko WC, et al. Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) and coronavirus
    disease-2019 (COVID-19): The epidemic and the challenges. Int J Antimicrob Agents. 2020; Mar 55(3): 105924.doi:

  • Carefully read these instructions prior to using
    Panbio™ COVID-19 Ag Rapid Test Device kit.
  • Lisez attentivement ces instructions avant
    d’utiliser le kit de Panbio™ COVID-19 Ag Rapid
    Test Device.

  • Перед использованием Экспресс-теста
    Panbio™ COVID-19 Ag (Panbio™ COVID-19
    Ag Rapid Test Device) внимательно
    прочитайте данные инструкции.
    Lesen Sie diese Anleitung vor Verwendung des

  • Panbio™ COVID-19 Ag Rapid Test Device
    sorgfältig durch.

  • Leggere attentamente queste istruzioni prima
    di utilizzare il kit Panbio™ COVID-19 Ag Rapid
    Test Device.
    Lea cuidadosamente estas instrucciones de uso
    antes de usar Panbio™ COVID-19 Ag Rapid
    Test Device kit.
    Leia atentamente estas instruções antes de usar
    o kit Panbio™ COVID-19 Ag Rapid Test Device.
    Look at the expiration date of the kit box. If the
    expiration date has passed, use another kit.
    Regardez la date d’expiration de la boîte du kit.
    Si la date d’expiration est dépassée, utilisez un
    autre kit.
    Проверьте срок годности набора. Если
    срок годности прошел, используйте
    другой набор.
    Beachten Sie das Verfallsdatum der KitBox. Wenn das Verfallsdatum abgelaufen ist,
    verwenden Sie einen anderen Kit
    Guarda la data di scadenza della scatola del kit.
    Se la data di scadenza è trascorsa, usa un altro
    Revise la fecha de vencimiento de la caja del kit.
    Si la fecha de vencimiento ha pasado, use otro
    Observe a data de validade da caixa do kit. Se a
    data de validade já passou, use outro kit.

Open the foil pouch and look for the following:

Result window

Specimen well
Then, label the device with the patient identifier.
Ouvrez la pochette en aluminium et recherchez
les éléments suivants:

Fenêtre de résultats

Échantillon bien
Ensuite, étiquetez l’appareil avec l’identifiant du
Откройте индивидуальную упаковку тесткассеты и проверьте комплектность:

Окно результата

Ячейка для образца
Затем наклейте на тест-кассету
идентификатор пациента.
Öffnen Sie den Folienbeutel und schauen Sie nach


Beschriften Sie die Testkassette mit der Patient-ID.
Aprire la busta di alluminio e cercare quanto

Finestra dei risultati

Pozzetto del campione
Quindi, etichettare il dispositivo con l’identificatore
del paziente.
Abra la bolsa de aluminio y revise lo siguiente:

Ventana de resultados

Pocillo de muestra
Luego, rotule el dispositivo con el identificador del
Abra a bolsa de alumínio e observe o seguinte:

Janela de resultados

Cavidade de amostra
Em seguida, rotule o dispositivo com o
identificador do paciente.
: 5 drops of the extracted specimen / 5 Tropfen der extrahierten Probe / 5 gotas de la muestra extraída
/ 5 gouttes de l’échantillon extrait / 5 gocce del campione estratto / 5 gotas da amostra extraída
/ 5 капель раствора из экстракционной пробирки
1 2
The presence of the test line (T) and the control
line (C) within the result window, regardless
of which line appears first, indicates a positive
Caution: The presence of any test line (T),
no matter how faint, indicates a positive result.
La présence de la ligne de test (T) et de la ligne
de contrôle (C) dans la fenêtre de résultat,
quelle que soit la ligne qui apparaît en premier,
indique un résultat positif.
Attention: la présence d’une ligne de test
(T), aussi faible soit-elle, indique un résultat
Положительный результат: Наличие
тестовой (T) и контрольной (C) линии в
окне результата, независимо от того, какая
линия появляется первой, указывает на
положительный результат.
Предупреждение: Наличие тестовой
линии (Т), какой бы слабой она ни была,
свидетельствует о положительном
Erscheinen eine Kontrolllinie (C) und eine Testlinie
(T) innerhalb des Testergebnislesefensters,
unabhängig davon, welche Linie zuerst erscheint,
ist das Ergebnis positiv.
Achtung: Jede Testlinie (T), unabhängig
davon, wie schwach diese Linie ist, ist als positives
Testergebnis zu bewerten.
La presenza della linea di test (T) e della
linea di controllo (C) all’interno della finestra
dei risultati, indipendentemente dalla linea
visualizzata per prima, indica un risultato
Attenzione: La presenza di qualsiasi linea di
test (T), non importa quanto debole, indica un
risultato positivo.
La presencia de la línea de prueba (T) y la
línea de control (C) dentro de la ventana de
resultados, independientemente de la línea que
aparezca primero, indica un resultado positivo.
Precaución: La presencia de cualquier
línea de prueba (T), no importa cuán débil sea,
indica un resultado positivo.
A presença da linha de teste (T) e da linha de
controle (C) dentro da janela de resultados,
independentemente de qual linha apareça
primeiro, indica um resultado positivo.
Cuidado: A presença de qualquer linha de
teste (T), não importa o quão tênue, indica um
resultado positivo.
If the control line (C) is not visible within the
result window after performing the test, the
result is considered invalid. Instructions may not
have been followed correctly. It is recommended
to read the IFU again before re-testing the
specimen with a new test device.
Si la ligne de contrôle (C) n’est pas visible dans
la fenêtre de résultat après l’exécution du test,
le résultat est considéré comme invalide. Les
instructions peuvent ne pas avoir été suivies
correctement. Il est recommandé de relire la
notice d’utilisation avant de tester à nouveau
l’échantillon avec un nouveau dispositif de test.
Если контрольная линия (С) не
видна в окне результатов после
выполнения теста, результат считается
неверным. Инструкции могли быть
выполнены неправильно. В этом
случае рекомендуется снова прочитать
инструкцию по применению перед
повторным тестированием образца с
использованием новой тест-кассетой.
Date Issued : 2020.08
Ist die Kontrolllinie (C) nach der Testdurchführung
innerhalb des Testergebnislesefensters nicht
sichtbar, ist das Ergebnis ungültig.
Die Anweisungen wurden möglicherweise nicht
korrekt befolgt. Es wird empfohlen, die IFU
erneut zu lesen, bevor die Probe mit einer neuen
Testkassette erneut getestet wird.
Se la linea di controllo (C) non è visibile
all’interno della finestra dei risultati dopo
l’esecuzione del test, il risultato viene
considerato non valido. Le istruzioni potrebbero
non essere state seguite correttamente. Si
consiglia di leggere nuovamente il foglietto
illustrativo prima di testare nuovamente il
campione con un nuovo dispositivo di test.
Si la línea de control (C) no está visible dentro
de la ventana de resultados después de realizar
la prueba, el resultado se considera inválido. Es
posible que las instrucciones no se hayan seguido
correctamente. Se recomienda volver a leer las
instrucciones de uso antes de volver a analizar la
muestra con un nuevo dispositivo de prueba.
Se a linha de controle (C) não estiver visível
na janela de resultados após a realização do
teste, o resultado é considerado inválido.
As instruções podem não ter sido seguidas
corretamente. É recomendável ler o a instrução
de uso novamente antes de testar novamente a
amostra com um novo dispositivo de teste.
6 7 8 9 Open the
dropping nozzle
cap at the bottom
of the extraction
Abra la tapa de
la boquilla de
goteo en la parte
inferior del tubo
de extracción.
Aprire il tappo
posizionato nella
parte inferiore
della provetta di
Откройте крышку
колпачка –
капельницы в
нижней части
Öffnen Sie die Kappe
der Dosieröffnung
am Boden des
Ouvrez le
capuchon de la
buse à goutte
au bas du tube
Abra a tampa
do bico de
gotejamento na
parte inferior do
tubo de extração.
Start timer. Read
result at 15 minutes.
Do not read results
after 20 minutes.
De inicio al
temporizador. Leer
resultado a los 15
minutos. No lea los
resultados después
de 20 minutos.
Avviare il timer.
Leggere il risultato
a 15 minuti. Non
leggere i risultati
dopo 20 minuti.
Запустите таймер.
Результат можно
считывать через 15
минут. Не считывайте
результаты, если прошло
20 минут и больше.
Starten Sie die Uhr
und lesen Sie das
Ergebnis nach 15
Minuten ab. Lesen
Sie das Ergebnis
nicht mehr nach 20
Minuten ab.
Démarrer le
minuteur, lire le
résultat à 15 minutes.
Ne pas lire le résultat
après 20 minutes.
Inicie o cronômetro.
Leia o resultado
do teste em 15
minutos. Não leia os
resultados após 20
Dispense 5 drops of extracted specimens vertically into the
specimen well (S) on the device. Do not handle or move the
test device until the test is complete and ready for reading.
Caution: Bubbles that occur in the extraction tube
can lead to inaccurate results. If you are unable to create
sufficient drops, this may be caused by clogging in the
dispensing nozzle. Shake the tube gently to release the
blockage until you observe free drop formation.
Dispense 5 gotas de las muestras extraídas verticalmente en
el pocillo de la muestra (S) en el dispositivo. No manipule
ni mueva el dispositivo de prueba hasta que la prueba esté
completa y lista para leer.
Precaución: Las burbujas que se forman en el tubo
de extracción pueden dar lugar a resultados incorrectos.
Si no puede crear suficientes gotas, esto puede deberse a
una obstrucción en la boquilla dispensadora. Agite el tubo
suavemente para liberar el bloqueo hasta que observe la
formación de gotas libres.
Dispensare 5 gocce di campione estratto verticalmente
nel pozzetto del test (S) sul dispositivo. Non maneggiare o
spostare il dispositivo fino a quando il test non è completo e
pronto per la lettura.
Attenzione: La comparsa di bolle nella provetta di
estrazione può portare a risultati imprecisi. Se non si riuscisse
ad ottenere un numero di gocce sufficienti, ciò potrebbe
essere causato dall’intasamento dell’ugello di erogazione.
Agitare delicatamente la provetta per rimuovere l’ostruzione
fino a osservare la formazione di goccia libera.
Внесите 5 капель раствора из экстракционной
пробирки вертикально в ячейку для образца (S) на
тест-кассете. Не трогайте и не перемещайте тесткассету, пока тест не будет завершен и готов к
Предупреждение: Пузырьки, возникающие
в экстракционной пробирке, могут привести к
неточным результатам. Если отмерить достаточное
количество капель не удается, это может быть
вызвано засорением колпачка-капельницы.
Осторожно встряхните пробирку, чтобы устранить
обструкцию, пока не образуются свободные капли.
Geben Sie 5 Tropfen der extrahierten Proben senkrecht
in die Probenvertiefung (S) der Testkassette. Bewegen Sie
die Testkassette nicht, bis der Test abgeschlossen und zum
Ablesen bereit ist.
Achtung: Blasen, die im Extraktionsröhrchen auftreten,
können zu ungenauen Ergebnissen führen. Wenn Sie nicht
in der Lage sind, genügend Tropfen zu erzeugen, kann dies
an einer Verstopfung der Dosieröffnung liegen. Schütteln
Sie das Röhrchen leicht, um die Verstopfung zu lösen, bis Sie
eine freie Tropfenbildung beobachten können.
Distribuer verticalement 5 gouttes d’échantillons extraits
dans le puits d’échantillon (S) de l’appareil. Ne pas manipuler
ni déplacer le dispositif de test tant que le test n’est pas
terminé et prêt pour la lecture.
Attention: les bulles qui se produisent dans le tube
d’extraction peuvent conduire à des résultats inexacts. Si
vous ne parvenez pas à créer suffisamment de gouttes,
cela peut être dû à un colmatage de la buse de distribution.
Secouez doucement le tube pour libérer le blocage jusqu’à ce
que vous observiez la formation de gouttes libres.
Dispense 5 gotas das amostras extraídas verticalmente na
cavidade da amostra (S) do dispositivo. Não manuseie ou
mova o dispositivo de teste até que o teste esteja concluído e
pronto para leitura.
Cuidado: As bolhas que ocorrem no tubo de
extração podem levar a resultados imprecisos. Se você não
conseguir criar gotas suficientes, isso pode ser causado por
entupimento no bico dispensador. Agite o tubo suavemente
para liberar o bloqueio até observar a formação livre de gotas.
5 x
Close the nozzle
and dispose of the
extraction tube
containing the used
swab according to your
local regulations and
biohazard waste disposal
Cierre la boquilla y
deseche el tubo de
extracción que contiene el
hisopo usado de acuerdo
con las regulaciones
locales y el protocolo de
eliminación de desechos
de riesgo biológico.
Chiudere l’ugello e
smaltire la provetta di
estrazione contenente
il tampone usato in
base alle normative
locali e al protocollo di
smaltimento dei rifiuti
Закройте колпачоккапельницу, и утилизируйте
пробирку, содержащую
использованный тампон в
соответствии с местными
правилами и протоколом
утилизации биологически
опасных отходов.
Schließen Sie die
Dosieröffnung und entsorgen
Sie das Extraktionsröhrchen
mit dem gebrauchten
Tupfer gemäß den örtlichen
Vorschriften und dem
Entsorgungsprotokoll für
biologisch gefährliche Abfälle.
Fermez la buse et jetez
le tube d’extraction
avec l’écouvillon usagé
conformément à
vos réglementations
locales et au protocole
d’élimination des déchets
Feche o bico e descarte
o tubo de extração
contendo o swab usado
de acordo com os
regulamentos locais e o
protocolo de descarte
de resíduos de risco

2 Open the package and look for the following:

  • Test device with desiccant in individual
    foil pouch
  • Buffer
  • Extraction tube
  • Extraction tube cap
  • Positive control swab
  • Negative control swab
  • Sterilized nasopharyngeal swabs for
    sample collection
  • Tube rack
  • Quick reference guide (Nasopharyngeal)
  • Instructions for use
    Ouvrez la boite et recherchez les éléments
  • Testeur avec déshydratant dans un sachet
    individuel en aluminium
  • Solution tampon
  • Tube d’extraction
  • Bouchon pour les tubes d’extraction
  • Écouvillon de contrôle positif
  • Écouvillon de contrôle négatif
  • Écouvillons nasopharyngés stérilisés pour
    le prélèvement d’échantillons
  • Porte tubes
  • Guide de référence rapide
  • Notice d’utilisation
    Откройте упаковку и проверьте комплектность:
  • Тест-кассета в индивидуальной вакуумной упаковке с
  • Буфер
  • Пробирка экстракционная
  • Колпачок для пробирки экстракционной
  • Положительный контрольный образец
  • Отрицательный контрольный образец
  • Стерильные назофарингеальные тампоны (тупферов) для
    сбора образцов
  • Штатив
  • Краткое руководство (назофарингеальный тампон)
  • Инструкция по применению
    Öffnen Sie die Verpackung und Entnehmen
    Sie Folgendes:
  • Testkassetten verpackt in Folienbeutel
    mit Trockenmittel
  • Puffer
  • Extraktionsröhrchen
  • Deckel für Extraktionsröhrchen
  • Positivkontrolltupfer
  • Negativkontrolltupfer
  • Sterilisierte nasopharyngeale Tupfer zur
  • Ständer für Röhrchen
  • Kurzanleitung (Nasopharyngeal)
  • Gebrauchsanweisung
    Aprire la confezione e cercare quanto segue:
  • Dispositivo di test confezionato
    singolarmente in busta di alluminio con
  • Buffer
  • Provetta di estrazione
  • Tappo della provetta di estrazione
  • Tampone di controllo positivo
  • Tampone di controllo negativo
  • Tamponi sterili nasofaringei per la
    raccolta del campione
  • Rack portaprovette
  • Guida rapida di riferimento
  • Istruzioni per l’uso
    Abra el paquete y revise los siguientes
  • Dispositivo de prueba con desecante en
    bolsa de aluminio individual
  • Solución tampón
  • Tubo de extracción
  • Tapa de tubos de extracción
  • Hisopo control positivo
  • Hisopo control negativo
  • Hisopos nasofaríngeos esterilizados para
    la recolección de muestras
  • Gradilla para tubos
  • Guía de referencia rápida (nasofaríngea)
  • Instrucciones de uso
    Abra o pacote e observe o seguinte:
  • Dispositivo de teste com dessecante em
    bolsa individual
  • Tampão
  • Tubo de extração
  • Tampa de tubos de extração
  • Swab controle positivo
  • Swab controle negativo
  • Swabs nasofaríngeos esterilizados para
    coleta de amostra
  • Suporte para tubos

Guia de referência rápida (nasofaríngea)

device according to
your local regulations
and biohazard waste
disposal protocol.
Deseche el dispositivo
usado de acuerdo
con las regulaciones
locales y el protocolo
de eliminación de
desechos de riesgo
Smaltire il dispositivo
usato in base alle
normative locali
e al protocollo di
smaltimento dei rifiuti
Использованную тесткассету утилизируют
в соответствии с
местными правилами и
протоколом утилизации
биологически опасных
Entsorgen Sie
die gebrauchte
Testkassette gemäß
den örtlichen
Vorschriften und dem
für biologisch
gefährlichen Abfall.
L’Elimination des
appareils usagés se fait
conformément à la
réglementation locale
en vigueur et selon le
protocole d’élimination
des déchets dangereux.
Descarte o dispositivo
usado de acordo com
os regulamentos
locais e o protocolo de
descarte de resíduos de
risco biológico.
Nr. Art der Probe Kreuzreaktionssubstanz Finale Testkonzentration Testergebnis
Staphylococcus aureus 1,0 X 106,0 CFU/ml Keine Kreuzreaktion
2 Staphylococcus saprophyticus 1,0 X 106,0 CFU/ml Keine Kreuzreaktion
3 Neisseria sp,(Neisseria lactamica) 1,0 X 106,0 CFU/ml Keine Kreuzreaktion
4 Escherichia coli 1,0 X 106,0 CFU/ml Keine Kreuzreaktion
5 Staphylococcus haemolyticus 1,0 X 106,0 CFU/ml Keine Kreuzreaktion
6 Streptococcus pyogenes 1,0 X 106,0 CFU/ml Keine Kreuzreaktion
7 Streptococcus salivarius 1,0 X 106,0 CFU/ml Keine Kreuzreaktion
8 Hemophilus parahaemolyticus 1,0 X 106,0 CFU/ml Keine Kreuzreaktion
9 Proteus vulgaris 1,0 X 106,0 CFU/ml Keine Kreuzreaktion
10 Moraxella catarrhalis 1,0 X 106,0 CFU/ml Keine Kreuzreaktion
11 Klebsiella pneumoniae 1,0 X 106,0 CFU/ml Keine Kreuzreaktion
12 Fusobacterium necrophorum 1,0 X 106,0 CFU/ml Keine Kreuzreaktion

  • Keine Konzentrationsangabe durch den Lieferanten. Unverdünnte Stammlösung wurde getestet.
  1. Interferierende Substanzen
    Die folgenden 28 potenziell interferierenden Substanzen haben keinen Einfluss auf Panbio™ COVID-19 Ag Rapid Test Device. Die
    endgültigen Testkonzentrationen der Störsubstanzen sind in der folgenden Tabelle dokumentiert.
    Nr. Art der Probe Interferierende Substanzen Finale Testkonzentration Testergebnis
    Endogene Substanz
    Mucin 0,5% Keine Interferenz
    2 Hämoglobin 100 mg/L Keine Interferenz
    3 Triglyceride 1,5 mg/L Keine Interferenz
    4 Icteric (Bilirubin) 40 mg/dL Keine Interferenz
    5 Rheuma-Faktor 200 IU/ml Keine Interferenz
    6 Anti-nuklearer Antikörper >1:40 Keine Interferenz
    7 Schwanger 10-fach verdünnt Keine Interferenz
    Exogene Substanz
    Guajakol-Glyceryl-Ether 1 μg/ml Keine Interferenz
    9 Albuterol 0,005 mg/dL Keine Interferenz
    10 Ephedrin 0,1 mg/ml Keine Interferenz
    11 Chlorpheniramin 0,08 mg/dL Keine Interferenz
    12 Diphenhydramin 0,08 mg/dL Keine Interferenz
    13 Ribavirin 26,7 μg /ml Keine Interferenz
    14 Oseltamivir 0,04 mg/dL Keine Interferenz
    15 Zanamivir 17,3 μg /ml Keine Interferenz
    16 Phenylephrin-Hydrochlorid 15% v/v Keine Interferenz
    17 Oxymetazolin-Hydrochlorid 15% v/v Keine Interferenz
    18 Amoxicillin 5,4 mg/dL Keine Interferenz
    19 Acetylsalicylsäure 3 mg/dL Keine Interferenz
    20 Ibuprofen 21,9 mg/dL Keine Interferenz
    21 Chlorothiazid 2,7 mg/dL Keine Interferenz
    22 Indapamid 140 ng/ml Keine Interferenz
    23 Glimepirid (Sulfonylharnstoffe) 0,164 mg/dL Keine Interferenz
    24 Acarbose 0,03 mg/dL Keine Interferenz
    25 Ivermectin 4,4 mg/L Keine Interferenz
    26 Lopinavir 16,4 μg/L Keine Interferenz
    27 Ritonavir 16,4 μg/L Keine Interferenz
    28 Chloroquinphosphat 0,99 mg/L Keine Interferenz
  2. Wiederholbarkeit & Reproduzierbarkeit
    Die Wiederholbarkeit und Reproduzierbarkeit von Panbio™ COVID-19 Ag Rapid Test Device wurde unter Verwendung eines internen
    Referenzpanels mit negativen Proben und einer Reihe positiver Proben festgestellt. Es wurden keine Unterschiede innerhalb der Testreihe,
    zwischen den Testreihen, zwischen den Chargen, zwischen den Standorten und zwischen den Tagen festgestellt.
    No, Types d’ échantillons Substance de réaction croisée Concentration finale du test Résultat du Test
    Staphylococcus aureus 1,0 X 106,0 CFU/ml Pas de réaction croisée
    2 Staphylococcus saprophyticus 1,0 X 106,0 CFU/ml Pas de réaction croisée
    3 Neisseria sp.(Neisseria lactamica) 1,0 X 106,0 CFU/ml Pas de réaction croisée
    4 Escherichia coli 1,0 X 106,0 CFU/ml Pas de réaction croisée
    5 Staphylococcus haemolyticus 1,0 X 106,0 CFU/ml Pas de réaction croisée
    6 Streptococcus pyogenes 1,0 X 106,0 CFU/ml Pas de réaction croisée
    7 Streptococcus salivarius 1,0 X 106,0 CFU/ml Pas de réaction croisée
    8 Hemophilus parahaemolyticus 1,0 X 106,0 CFU/ml Pas de réaction croisée
    9 Proteus vulgaris 1,0 X 106,0 CFU/ml Pas de réaction croisée
    10 Moraxella catarrhalis 1,0 X 106,0 CFU/ml Pas de réaction croisée
    11 Klebsiella pneumoniae 1,0 X 106,0 CFU/ml Pas de réaction croisée
    12 Fusobacterium necrophorum 1,0 X 106,0 CFU/ml Pas de réaction croisée
  • Aucune concentration fournie par le fournisseur. La solution mère non diluée a été testée.
  1. Substances interférentes
    Les 28 substances potentiellement interférentes suivantes n’ont aucun impact sur le Panbio™ COVID-19 Ag Rapid Test Device. Les
    concentrations d’essai finales des substances interférentes sont documentées dans le tableau ci-dessous.
    No, Types d’ échantillons Substances interférentes Concentration finale du test Résultat du Test
    Substance Endogène
    Mucine 0,5% Pas d’interférence
    2 Hémoglobine 100 mg/L Pas d’interférence
    3 Triglycérides 1,5 mg/L Pas d’interférence
    4 Ictère (Bilirubine) 40 mg/dL Pas d’interférence
    5 Facteur Rhumatoïde 200 IU/ml Pas d’interférence
    6 Anticorps anti-nucléaire >1:40 Pas d’interférence
    7 Enceinte Dilution au dixième Pas d’interférence
    Substance Exogène
    Éther glycérylique de guaiacol 1 μg/ml Pas d’interférence
    9 Albuterol 0,005 mg/dL Pas d’interférence
    10 Ephedrine 0,1 mg/ml Pas d’interférence
    11 Chlorpheniramine 0,08 mg/dL Pas d’interférence
    12 Diphenhydramine 0,08 mg/dL Pas d’interférence
    13 Ribavirin 26,7 μg /ml Pas d’interférence
    14 Oseltamivir 0,04 mg/dL Pas d’interférence
    15 Zanamivir 17,3 μg /ml Pas d’interférence
    16 Chlorhydrate de phényléphrine 15% v/v Pas d’interférence
    17 Chlorhydrate d’oxymétazoline 15% v/v Pas d’interférence
    18 Amoxicilline 5,4 mg/dL Pas d’interférence
    19 Acide acétylsalicylique 3 mg/dL Pas d’interférence
    20 Ibuprofène 21,9 mg/dL Pas d’interférence
    21 Chlorothiazide 2,7 mg/dL Pas d’interférence
    22 Indapamide 140 ng/ml Pas d’interférence
    23 Glimépiride (sulfonylurées) 0,164 mg/dL Pas d’interférence
    24 Acarbose 0,03 mg/dL Pas d’interférence
    25 Ivermectine 4,4 mg/L Pas d’interférence
    26 Lopinavir 16,4 μg/L Pas d’interférence
    27 Ritonavir 16,4 μg/L Pas d’interférence
    28 Phosphate de chloroquine 0,99 mg/L Pas d’interférence
  2. Répétabilité et reproductibilité
    La répétabilité et la reproductibilité du Panbio™ COVID-19 Ag Rapid Test Device ont été établies à l’aide de panels de référence internes
    contenant des échantillons négatifs et une gamme d’échantillons positifs.. Aucune différence n’a été observée à l’intérieur des séries, entre les
    séries, entre les lots, entre les sites et entre les jours.
    Nº Tipos de Espécime Substância de Reação Cruzada Concentração de Teste Final Resultado do Teste
    Outro Microrganismo
    Staphylococcus aureus 1,0 X 106,0 CFU/ml Sem reação cruzada
    2 Staphylococcus saprophyticus 1,0 X 106,0 CFU/ml Sem reação cruzada
    3 Neisseria sp,(Neisseria lactamica) 1,0 X 106,0 CFU/ml Sem reação cruzada
    4 Escherichia coli 1,0 X 106,0 CFU/ml Sem reação cruzada
    5 Staphylococcus haemolyticus 1,0 X 106,0 CFU/ml Sem reação cruzada
    6 Streptococcus pyogenes 1,0 X 106,0 CFU/ml Sem reação cruzada
    7 Streptococcus salivarius 1,0 X 106,0 CFU/ml Sem reação cruzada
    8 Hemophilus parahaemolyticus 1,0 X 106,0 CFU/ml Sem reação cruzada
    9 Proteus vulgaris 1,0 X 106,0 CFU/ml Sem reação cruzada
    10 Moraxella catarrhalis 1,0 X 106,0 CFU/ml Sem reação cruzada
    11 Klebsiella pneumoniae 1,0 X 106,0 CFU/ml Sem reação cruzada
    12 Fusobacterium necrophorum 1,0 X 106,0 CFU/ml Sem reação cruzada
    *Nenhuma concentração fornecida pelo fornecedor. A solução estoque não diluída foi testada.
  3. Substâncias Interferentes
    As seguintes 28 substâncias potencialmente interferentes não têm impacto no Panbio™ COVID-19 Ag Rapid Test Device. As
    concentrações de teste finais das substâncias interferentes estão documentadas na Tabela abaixo.
    Nº Tipos de Espécime Substâncias Interferentes Concentração de Teste Final Resultado do Teste
    Substância Endógena
    Mucina 0,5% Sem Interferências
    2 Hemoglobina 100 mg/L Sem Interferências
    3 Triglicerídeos 1,5 mg/L Sem Interferências
    4 Icterícia (bilirrubina) 40 mg/dL Sem Interferências
    5 Fatores reumatoides 200 IU/ml Sem Interferências
    6 Anticorpo antinuclear >1:40 Sem Interferências
    7 Grávida Diluição de 10 vezes Sem Interferências
    Substância Exógena
    Guaiacol gliceril éter 1 μg/ml Sem Interferências
    9 Albuterol 0,005 mg/dL Sem Interferências
    10 Efedrina 0,1 mg/ml Sem Interferências
    11 Clorfeniramina 0,08 mg/dL Sem Interferências
    12 Difenidramina 0,08 mg/dL Sem Interferências
    13 Ribavirina 26,7 μg /ml Sem Interferências
    14 Oseltamivir 0,04 mg/dL Sem Interferências
    15 Zanamivir 17,3 μg /ml Sem Interferências
    16 Cloridrato de fenilefrina 15% v/v Sem Interferências
    17 Cloridrato de oximetazolina 15% v/v Sem Interferências
    18 Amoxicilina 5,4 mg/dL Sem Interferências
    19 Ácido acetilsalicílico 3 mg/dL Sem Interferências
    20 Ibuprofeno 21,9 mg/dL Sem Interferências
    21 Clorotiazida 2,7 mg/dL Sem Interferências
    22 Indapamida 140 ng/ml Sem Interferências
    23 Glimepirida (Sulfonilureias) 0,164 mg/dL Sem Interferências
    24 Acarbose 0,03 mg/dL Sem Interferências
    25 Ivermectina 4,4 mg/L Sem Interferências
    26 Lopinavir 16,4 μg/L Sem Interferências
    27 Ritonavir 16,4 μg/L Sem Interferências
    28 Fosfato de cloroquina 0,99 mg/L Sem Interferências
  4. Repetibilidade e Reprodutibilidade
    Repetibilidade e reprodutibilidade do Panbio™ COVID-19 Ag Rapid Test Device foram estabelecidas usando painéis de referência
    internos contendo amostras negativas e uma gama de amostras positivas. Não houve diferenças observadas dentro da execução, entre
    execuções, entre lotes, entre locais e entre dias.
    No, Tipo de muestra Sustancia de reacción cruzada Concentración de prueba final Resultado de la prueba
    Staphylococcus aureus 1,0 X 106,0 CFU/mL Sin reacción cruzada
    2 Staphylococcus saprophyticus 1,0 X 106,0 CFU/mL Sin reacción cruzada
    3 Neisseria sp,(Neisseria lactamica) 1,0 X 106,0 CFU/mL Sin reacción cruzada
    4 Escherichia coli 1,0 X 106,0 CFU/mL Sin reacción cruzada
    5 Staphylococcus haemolyticus 1,0 X 106,0 CFU/mL Sin reacción cruzada
    6 Streptococcus pyogenes 1,0 X 106,0 CFU/mL Sin reacción cruzada
    7 Streptococcus salivarius 1,0 X 106,0 CFU/mL Sin reacción cruzada
    8 Hemophilus parahaemolyticus 1,0 X 106,0 CFU/mL Sin reacción cruzada
    9 Proteus vulgaris 1,0 X 106,0 CFU/mL Sin reacción cruzada
    10 Moraxella catarrhalis 1,0 X 106,0 CFU/mL Sin reacción cruzada
    11 Klebsiella pneumoniae 1,0 X 106,0 CFU/mL Sin reacción cruzada
    12 Fusobacterium necrophorum 1,0 X 106,0 CFU/mL Sin reacción cruzada
  • Sin concentración proporcionada por el proveedor. Se evaluó la solución madre sin diluir.
  1. Sustancias interferentes
    Las siguientes 28 sustancias potencialmente interferentes no tienen ningún impacto en Panbio™ COVID-19 Ag Rapid Test Device.
    Las concentraciones de prueba finales de las sustancias interferentes se documentan en la siguiente tabla.
    No, Tipo de muestra Sustancias Interferentes Concentración de prueba final Resultado de la prueba
    Sustancia Endógena
    Mucina 0,5% Sin interferencia
    2 Hemoglobina 100 mg/L Sin interferencia
    3 Triglicéridos 1,5 mg/L Sin interferencia
    4 Icterico (Bilirrubina) 40 mg/dL Sin interferencia
    5 Factor reumatoide 200 IU/mL Sin interferencia
    6 Anticuerpo antinuclear >1:40 Sin interferencia
    7 Embarazo Dilución de 10 veces Sin interferencia
    Sustancia Exógena
    Éter de glicerilo guayacol 1 μg/mL Sin interferencia
    9 Albuterol 0,005 mg/dL Sin interferencia
    10 Efedrina 0,1 mg/mL Sin interferencia
    11 Clorfeniramina 0,08 mg/dL Sin interferencia
    12 Difenhidramina 0,08 mg/dL Sin interferencia
    13 Ribavirina 26,7 μg /mL Sin interferencia
    14 Oseltamivir 0,04 mg/dL Sin interferencia
    15 Zanamivir 17,3 μg /mL Sin interferencia
    16 Clorhidrato de fenilefrina 15% v/v Sin interferencia
    17 Clorhidrato de oximetazolina 15% v/v Sin interferencia
    18 Amoxicilina 5,4 mg/dL Sin interferencia
    19 Ácido acetilsalicílico 3 mg/dL Sin interferencia
    20 Ibuprofeno 21,9 mg/dL Sin interferencia
    21 Clorotiazida 2,7 mg/dL Sin interferencia
    22 Indapamida 140 ng/mL Sin interferencia
    23 Glimepirida (sulfonilureas) 0,164 mg/dL Sin interferencia
    24 Acarbose 0,03 mg/dL Sin interferencia
    25 Ivermectina 4,4 mg/L Sin interferencia
    26 Lopinavir 16,4 μg/L Sin interferencia
    27 Ritonavir 16,4 μg/L Sin interferencia
    28 Fosfato de cloroquina 0,99 mg/L Sin interferencia
  2. Repetibilidad y reproducibilidad
    La repetibilidad y reproducibilidad de Panbio™ COVID-19 Ag Rapid Test Device se estableció utilizando paneles de referencia
    internos que contienen muestras negativas y una variedad de muestras positivas. No se observaron diferencias dentro de las
    evaluaciones, entre evaluaciones, entre lotes, entre sitios y entre días.
    No, Tipi di campione Elemento di cross-reazione Concentrazione finale di test Risultato del test
    Altro Microorganismo
    Staphylococcus aureus 1,0 X 106,0 CFU/ml Nessuna cross reazione
    2 Staphylococcus saprophyticus 1,0 X 106,0 CFU/ml Nessuna cross reazione
    3 Neisseria sp,(Neisseria lactamica) 1,0 X 106,0 CFU/ml Nessuna cross reazione
    4 Escherichia coli 1,0 X 106,0 CFU/ml Nessuna cross reazione
    5 Staphylococcus haemolyticus 1,0 X 106,0 CFU/ml Nessuna cross reazione
    6 Streptococcus pyogenes 1,0 X 106,0 CFU/ml Nessuna cross reazione
    7 Streptococcus salivarius 1,0 X 106,0 CFU/ml Nessuna cross reazione
    8 Hemophilus parahaemolyticus 1,0 X 106,0 CFU/ml Nessuna cross reazione
    9 Proteus vulgaris 1,0 X 106,0 CFU/ml Nessuna cross reazione
    10 Moraxella catarrhalis 1,0 X 106,0 CFU/ml Nessuna cross reazione
    11 Klebsiella pneumoniae 1,0 X 106,0 CFU/ml Nessuna cross reazione
    12 Fusobacterium necrophorum 1,0 X 106,0 CFU/ml Nessuna cross reazione
  • Nessuna concentrazione fornita dal fornitore. È stata testata una soluzione di stock non diluito.
  1. Sostanze interferenti
    Le seguenti 28 sostanze potenzialmente interferenti non hanno alcun impatto su Panbio™ COVID-19 Ag Rapid Test Device. La
    concentrazione finale di test delle sostanze interferenti è documentata nella tabella sotto.
    No, Tipi di campione Sostanze interferenti Concentrazione finale di test Risultato del test
    Sostanza endogena
    Mucin 0,5% Nessuna interferenza
    2 Hemoglobin 100 mg/L Nessuna interferenza
    3 Triglycerides 1,5 mg/L Nessuna interferenza
    4 Icteric (Bilirubin) 40 mg/dL Nessuna interferenza
    5 Rheumatoid factor 200 IU/ml Nessuna interferenza
    6 Anti-nuclear antibody >1:40 Nessuna interferenza
    7 Pregnant Diluizione 1:10 Nessuna interferenza
    Sostanza esogena
    Guaiacol glyceryl ether 1 μg/ml Nessuna interferenza
    9 Albuterol 0,005 mg/dL Nessuna interferenza
    10 Ephedrine 0,1 mg/ml Nessuna interferenza
    11 Chlorpheniramine 0,08 mg/dL Nessuna interferenza
    12 Diphenhydramine 0,08 mg/dL Nessuna interferenza
    13 Ribavirin 26,7 μg /ml Nessuna interferenza
    14 Oseltamivir 0,04 mg/dL Nessuna interferenza
    15 Zanamivir 17,3 μg /ml Nessuna interferenza
    16 Phenylephrine hydrochloride 15% v/v Nessuna interferenza
    17 Oxymetazolin hydrochloride 15% v/v Nessuna interferenza
    18 Amoxicillin 5,4 mg/dL Nessuna interferenza
    19 Acetylsalicylic acid 3 mg/dL Nessuna interferenza
    20 Ibuprofen 21,9 mg/dL Nessuna interferenza
    21 Chlorothiazide 2,7 mg/dL Nessuna interferenza
    22 Indapamide 140 ng/ml Nessuna interferenza
    23 Glimepiride (Sulfonylureas) 0,164 mg/dL Nessuna interferenza
    24 Acarbose 0,03 mg/dL Nessuna interferenza
    25 Ivermectin 4,4 mg/L Nessuna interferenza
    26 Lopinavir 16,4 μg/L Nessuna interferenza
    27 Ritonavir 16,4 μg/L Nessuna interferenza
    28 Chloroquine phosphate 0,99 mg/L Nessuna interferenza
  2. Ripetibilità e riproducibilità
    La ripetibilità e la riproducibilità di Panbio™ COVID-19 Ag Rapid Test Device sono state stabilite utilizzando pannelli di riferimento
    interni contenenti campioni positivi alti, positivi medi, positivi deboli e negativi. Non sono state osservate differenze all’interno della
    serie, tra le serie, tra i lotti, tra i siti e tra i giorni.
    № Типы образцов Вещество, вызывающее перекрестную реакцию Окончательная тестовая
    концентрация Результаты теста
    Staphylococcus aureus 1,0 X 106.0 КОЕ/мл Нет перекрестной реакции
    2 Staphylococcus saprophyticus 1,0 X 106.0 КОЕ/мл Нет перекрестной реакции
    3 Neisseria sp.(Neisseria lactamica) 1,0 X 106.0 КОЕ/мл Нет перекрестной реакции
    4 Escherichia coli 1,0 X 106.0 КОЕ/мл Нет перекрестной реакции
    5 Staphylococcus haemolyticus 1,0 X 106.0 КОЕ/мл Нет перекрестной реакции
    6 Streptococcus pyogenes 1,0 X 106.0 КОЕ/мл Нет перекрестной реакции
    7 Streptococcus salivarius 1,0 X 106.0 КОЕ/мл Нет перекрестной реакции
    8 Hemophilus parahaemolyticus 1,0 X 106.0 КОЕ/мл Нет перекрестной реакции
    9 Proteus vulgaris 1,0 X 106.0 КОЕ/мл Нет перекрестной реакции
    10 Moraxella catarrhalis 1,0 X 106.0 КОЕ/мл Нет перекрестной реакции
    11 Klebsiella pneumoniae 1,0 X 106.0 КОЕ/мл Нет перекрестной реакции
    12 Fusobacterium necrophorum 1,0 X 106.0 КОЕ/мл Нет перекрестной реакции
    *Поставщик не предоставил концентрации. Был протестирован неразбавленный исходный раствор.
  3. Интерферирующие вещества
    Следующие 28 потенциально интерферирующих веществ не оказывают никакого влияния на Экспресс-тест Panbio™
    COVID-19 Ag (Panbio™ COVID-19 Ag Rapid Test Device). Окончательные тестовые концентрации интерферирующих веществ
    задокументированы в нижеприведенной таблице.
    № Типы образцов Интерферирующие вещества Окончательная тестовая концентрация Результаты теста
    Эндогенная субстанция
    Муцин 0,5% Нет влияния
    2 Гемоглобин 100 мг/л Нет влияния
    3 Триглицериды 1,5 мг/л Нет влияния
    4 Билирубин 40 мг/дл Нет влияния
    5 Ревматоидный фактор 200 МЕ/мл Нет влияния
    6 Антиядерное антитело >1:40 Нет влияния
    7 Беременность 10-кратное разведение Нет влияния
    Экзогенная субстанция
    Глицериловый эфир гваяколя 1 мкг/мл Нет влияния
    9 Альбутерол 0,005 мг/дл Нет влияния
    10 Эфедрин 0,1 мг/мл Нет влияния
    11 Хлорфенирамин 0,08 мг/дл Нет влияния
    12 Дифенгидрамин 0,08 мг/дл Нет влияния
    13 Рибавирин 26,7 мкг/мл Нет влияния
    14 Осельтамивир 0,04 мг/дл Нет влияния
    15 Занамивир 17,3 мкг/мл Нет влияния
    16 Фенилэфрина гидрохлорид 15% об./об. Нет влияния
    17 Оксиметазолина гидрохлорид 15% об./об. Нет влияния
    18 Амоксициллин 5,4 мг/дл Нет влияния
    19 Ацетилсалициловая кислота 3 мг/дл Нет влияния
    20 Ибупрофен 21,9 мг/дл Нет влияния
    21 Хлортиазид 2,7 мг/дл Нет влияния
    22 Индапамид 140 нг/мл Нет влияния
    23 Глимепирид (Сульфонилмочевина) 0,164 мг/дл Нет влияния
    24 Акарбоза 0,03 мг/дл Нет влияния
    25 Ивермектин 4,4 мг/л Нет влияния
    26 Лопинавир 16,4 мкг/л Нет влияния
    27 Ритонавир 16,4 мкг/л Нет влияния
    28 Хлорохина фосфат 0,99 мг/л Нет влияния
  4. Повторяемость и воспроизводимость
    Повторяемость и воспроизводимость Экспресс-тест Panbio™ COVID-19 Ag (Panbio™ COVID-19 Ag Rapid Test Device) была
    определена с использованием собственных эталонных панелей, содержащих отрицательные образцы и ряд положительных
    образцов. Различий в внутри одной серии, между сериями, между центрами и между днями не наблюдали.

    The presence of only the control line (C) and no
    test line (T) within the result window indicates a
    negative result.
    La présence seule de la ligne de contrôle (C)
    et aucune ligne de test (T) dans la fenêtre de
    résultat indique un résultat négatif.
    Наличие только контрольной линии
    (С) и отсутствие тестовой линии (Т) в
    окошке для считывания указывает на
    отрицательный результат теста.
    Erscheinen eine Kontrolllinie (C)
    und keine Testlinie (T) innerhalb des
    Testergebnislesefensters, ist das Ergebnis negativ.
    La presenza della sola linea di controllo (C) e
    nessuna linea di test (T) all’interno della finestra
    dei risultati indica un risultato negativo.
    La presencia de solo la línea de control (C) y
    ninguna línea de prueba (T) dentro de la ventana
    de resultados indica un resultado negativo.
    A presença apenas da linha de controle (C) e
    nenhuma linha de teste (T) dentro da janela de
    resultado indica um resultado negativo.
  5. In Vitro Diagnostic Assays for COVID-19: Recent Advances and Emerging Trends (Sandeep Kumar Vashist, 2020 April
    05: diagnostics)
  6. Nano Research for COVID-19 (http://dx.doi.org/10.1021/acsnano.0c02540)
  7. Coronavirus (COVID-19) Update: FDA Authorizes First Antigen Test to Help in the Rapid Detection of the Virus that
    Causes COVID-19 in Patients (Stephen M, Hahn M.D. 2020 May 09: Commisioner of Food and Drugs
  8. Current Intelligence Bulletin 13: Explosive Azide Hazard DHHS (NIOSH) Publication Number 78-127 August 16, 1976
  9. CDC. Discontinuation of Transmission-Based Precautions and Disposition of Patients with COVID-19 in Healthcare
    Settings (Interim Guidance). (2020).
  10. CDC. Duration of Isolation and Precautions for Adults with COVID-19. (2020).
    Europe & Middle East / Europa & Mittlerer Osten / Europa y Medio Oriente / Europe & Moyen Orient
    / Europe & Middle East / Europa e Oriente Médio / Европа, Ближний Восток
    +44 161 483 9032 | EMEproductsupport@abbott.com
    Africa, Russia & CIS / Afrika, Russland & CIS / África, Rusia y CEI / Afrique, Russie & CIS
    / Africa, Russia & CIS / África, Rússia e CEI / Африка, Россия и СНГ
    +27 10 500 9700 | ARCISproductsupport@abbott.com
    Asia Pacific / Asien Pazifik / Asia Pacífico / Asie Pacifique / Asia Pacific / Ásia-Pacífico / Азия, Океания +61 7 3363 7711 | APproductsupport@abbott.com
    Latin America / Lateinamerika / America Latina / Amérique Latine / Latin America / América Latina
    / Латинская Америка
    +57 2 661 8797 | LAproductsupport@abbott.com
    1 2 3 4 5 Hold the buffer bottle vertically and
    fill the extraction tube with buffer
    fluid until it flows up to the Fill-line
    of the extraction tube (300μl).
    Caution: If the amount of
    buffer is excessive or insufficient, an
    improper test result may occur.
    Sostenga el frasco de tampón
    verticalmente y llene el tubo de
    extracción con solución tampón
    hasta que fluya hasta la línea de
    llenado del tubo de extracción
    Precaución: Si la cantidad de
    tampón es excesiva o insuficiente,
    puede producirse un resultado de
    prueba incorrecto.
    Tenere il flacone del buffer
    verticalmente e riempire la provetta
    di estrazione fino alla linea di
    riempimento della provetta di
    estrazione (300 µl).
    Attenzione: Se la quantità di
    buffer è eccessiva o insufficiente,
    potrebbe verificarsi un risultato di
    test errato.
    Держа флакон с буфером
    вертикально наполните
    экстракционную пробирку
    буферным раствором, пока она
    не дойдет до линии заполнения
    экстракционной пробирки (300
    Предупреждение: Если
    объем буфера чрезмерен или
    недостаточен, результат теста
    может быть неправильным.
    Halten Sie das Pufferfläschchen
    vertikal und füllen Sie das
    Extraktionsröhrchen mit
    Pufferflüssigkeit, bis die Fülllinie des
    Extraktionsröhrchens erreicht ist
    (300 μl).
    Achtung: Bei einer zu hohen oder
    geringen Puffermenge sind falsche
    Testergebnisse möglich.
    Tenez le flacon de tampon
    verticalement et remplissez le tube
    d’extraction avec du liquide tampon
    jusqu’à ce qu’il s’écoule jusqu’à la ligne
    de remplissage du tube d’extraction
    (300 μl).
    Attention: Si la quantité de
    tampon est excessive ou insuffisante,
    un résultat de test incorrect peut se
    Segure o frasco de tampão
    verticalmente e encha o tubo de
    extração com fluido de tampão
    até que ele flua até a linha de
    enchimento do tubo de extração
    Cuidado: Se a quantidade de
    tampão for excessiva ou insuficiente,
    um resultado de teste impróprio
    pode ocorrer.
    Break the swab at
    the breakpoint and
    close the cap of
    extraction tube.
    Tilt the patient’s head back.
    Insert the swab through the
    nostril. Gently rub and roll
    the swab, 3-4 times. Leave
    the swab in place for several
    seconds. Slowly remove swab. Quiebre el hisopo en
    el punto de ruptura
    y cierre la tapa del
    tubo de extracción.
    Incline la cabeza del paciente
    hacia atrás. Inserte el hisopo a
    traves de la fosa nasal. Frote y
    gire suavemente el hisopo, 3 a
    4 veces. Deje el hisopo en su
    lugar durante varios segundos.
    Retire lentamente el hisopo.
    Spezzare il tampone
    nel punto di rottura
    e chiudere il tappo
    della provetta di
    Inclinare la testa del paziente
    all’indietro. Inserire il tampone
    attraverso la narice. Strofinare
    e ruotare delicatamente il
    tampone 3-4 volte. Lasciare il
    tampone in posizione per alcuni
    secondi. Rimuovere lentamente
    il tampone.
    разламывают в
    точке разлома,
    и колпачок
    для пробирки
    Наклоняют голову пациента
    назад. Вставляют тампон
    через. Аккуратно потрите
    поверхность тампоном и
    поверните его 3-4 раза.
    Оставляют тампон на
    несколько секунд. Медленно
    извлекают тампон.
    Brechen Sie den Tupfer
    an der Bruchstelle
    ab und schließen
    Sie den Deckel des
    Neigen Sie den Kopf des
    Patienten nach hinten. Führen
    Sie den Tupfer durch das
    Nasenloch ein. Reiben und
    rollen Sie den Tupfer vorsichtig
    3-4 Mal. Lassen Sie den Tupfer
    für einige Sekunden an Ort
    und Stelle. Entfernen Sie den
    Tupfer langsam.
    Cassez l’écouvillon au
    point de rupture et
    fermez le capuchon
    du tube d’extraction.
    Inclinez la tête du patient en
    arrière. Insérez l’écouvillon
    dans la narine. Frottez et
    roulez doucement l’écouvillon,
    3 à 4 fois. Laissez l’écouvillon
    en place pendant plusieurs
    secondes. Retirez lentement
    Quebre o swab no
    ponto de quebra e
    feche a tampa do
    tubo de extração.
    Incline a cabeça do paciente
    para trás. Insira o swab pela
    narina. Esfregue e role
    suavemente o swab, 3-4 vezes.
    Deixe o swab no lugar por
    alguns segundos. Remova o
    swab lentamente.
    Place the
    extraction tube
    in the tube
    Coloque el tubo
    de extracción
    en la gradilla
    para tubos.
    la provetta
    di estrazione
    nel rack
    пробирку в
    Stellen Sie das
    in den
    Placez le tube
    dans le support
    de tubes.
    Coloque o tubo
    de extração
    no suporte de
    Insert the swab specimen in the
    extraction tube. Swirl the swab tip in the
    buffer fluid inside the extraction tube,
    pushing into the wall of the extraction
    tube at least five times and then squeeze
    out the swab by squeezing the extraction
    tube with your fingers.
    Inserte la muestra de hisopado en el tubo
    de extracción. Gire la punta del hisopo
    en la solución tampón dentro del tubo de
    extracción, empujando hacia la pared del
    tubo de extracción al menos cinco veces
    y luego exprima el hisopo apretando el
    tubo de extracción con los dedos.
    Inserire il tampone di campionamento
    nella provetta di estrazione. Ruotare la
    punta del tampone nel liquido all’interno
    della provetta di estrazione, spingendo
    sulla parete della provetta di estrazione
    almeno cinque volte e poi premere
    il tampone strizzando la provetta di
    estrazione con le dita.
    Вставьте тампон с образцом
    в экстракционную пробирку.
    Наконечник тампона
    проворачивают в буферном
    растворе внутри экстракционной
    пробирки, вдавливая его в стенку
    экстракционной пробирки не менее
    пяти раз, а затем тампон выжимают,
    сдавливая экстракционную
    пробирку пальцами.
    Führen Sie die Abstrichprobe in das
    Extraktionsröhrchen ein. Schwenken Sie
    die Tupferspitze in der Pufferflüssigkeit
    des Extraktionsröhrchens. Drücken Sie
    dabei den Tupfer mindestens fünfmal an
    die Wand des Extraktionsröhrchens und
    drücken Sie anschließend denn Tupfer
    aus, indem Sie mit den Fingern das
    Extraktionsröhrchen zusammendrücken.
    Insérez l’échantillon sur écouvillon dans le
    tube d’extraction. Faites tourbillonner la
    pointe de l’écouvillon dans le fluide tampon
    à l’intérieur du tube d’extraction, en
    poussant dans la paroi du tube d’extraction
    au moins cinq fois, puis faites sortir
    l’écouvillon en pressant le tube d’extraction
    avec vos doigts.
    Insira a amostra de esfregaço no tubo de
    extração. Gire a ponta do swab no fluido
    tampão dentro do tubo de extração,
    empurrando na parede do tubo de extração
    pelo menos cinco vezes e, em seguida,
    aperte o swab apertando o tubo de
    extração com os dedos.
    x 5

    1 Allow all kit components to reach a temperature
    between 15-30°C prior to testing for 30
    Note: Healthcare professionals should comply
    with personal safety guidelines including the use
    of personal protective equipment.
    Laissez tous les composants du kit atteindre une
    température comprise entre 15 et 30 ° C avant de
    procéder au test pendant 30 minutes.
    Remarque: le professionnel de santé doit se
    conformer aux directives de sécurité personnelle,
    y compris l’utilisation d’équipements de protection
    Перед тестированием выдержите все компоненты
    набора в течение 30 минут при температуре 15-30 °C
    Примечание: Медицинский работник должен
    соблюдать правила техники безопасности, включая
    использование средств индивидуальной защиты.
    Lassen Sie alle Komponenten des Test-Kits 30
    Minuten vor Beginn des Testens eine Temperatur
    von 15-30°C erreichen.
    Hinweis: Das medizinische Personal sollte die
    persönlichen Sicherheitsrichtlinien einschließlich
    der Verwendung persönlicher Schutzausrüstung
    Consentire a tutti i componenti del kit di
    raggiungere una temperatura tra 15-30°C per
    30 minuti prima dell’esecuzione del test.
    Nota: Gli operatori sanitari devono rispettare le
    linee guida per la sicurezza personale, incluso l’uso
    di dispositivi di protezione personale.
    Permita que todos los componentes del kit
    alcancen una temperatura entre 15 y 30 °C
    durante 30 minutos antes de realizar la prueba.
    Note: Los profesional de la salud deben cumplir
    con las pautas de seguridad personal, incluido el
    uso de equipo de protección personal.
    Deixe todos os componentes do kit atingirem
    uma temperatura entre 15-30°C antes do teste
    por 30 minutos.
    Nota: Profissionais de saúde devem cumprir as
    diretrizes de segurança pessoal, incluindo o uso
    de equipamento de proteção individual.

    Temperature limitation
    Limitación de temperatura
    Limitation de température
    Limitazione di temperatura
    Limitação de temperatura
    Температурный диапазон
    For in vitro diagnostic use only
    Medizinprodukt für in-vitro Diagnostik
    Sólo para uso diagnóstico in vitro
    Pour un usage de diagnostic in vitro uniquement
    Ad uso esclusivo diagnostico in vitro
    Somente para uso para diagnóstico in vitro
    Медицинское изделие для диагностики In Vitro
    Do not reuse
    Nicht wiederverwenden
    No reutilizar
    Ne pas réutiliser
    Non riutilizzare
    Não reutilizar
    Не использовать повторно
    Use By
    Verwendbar bis
    Usar por
    Utiliser par
    Utilizzare per
    Usar até
    Использовать до
    Contains sufficient for X tests
    Ausreichend für X Prüfungen
    Contiene suficiente para X pruebas
    Contient suffisamment pour les tests X
    Contenuto sufficiente per X test
    Contém suficiente para X testes
    Содержит материалы, достаточные для
    выполнения Х тестов
    Date of manufacture
    Fecha de manufactura
    Date de fabrication
    Data di produzione
    Data de fabricação
    Дата производства
    Catalog Number
    Número de catalogo
    Numéro de catalogue
    Numero di catalogo
    Número no Catálogo
    Каталожный номер
    Lot Number
    Número de lote
    Numéro de lot
    Numero di lotto
    Número de Lote
    Номер серии
    Consult instructions for use
    Gebrauchsanleitung beachten
    Consultar instrucciones de uso
    Consulter les instructions d’utilisation
    Consultare le istruzioni per l’uso
    Consulte as instruções de uso
    См. Инструкцию по применению
    Keep dry
    Trocken aufbewahren
    Mantener seco
    Garder au sec
    Mantenere asciutto
    Manter seco
    Хранить в сухом месте
    Biological Risks
    Biologisches Risiko
    Riesgos biológicos
    Risques biologiques
    Rischi biologici
    Riscos Biológicos
    Биологическая опасность
    Keep away from sunlight
    Von Sonnenlicht fernhalten
    Mantener alejado de la luz solar
    Tenir à l’écart de la lumière du soleil
    Tenere lontano dalla luce solare
    Manter longe da luz solar
    Беречь от попадания солнечных лучей
    Do not use if package is damaged
    Bei beschädigter Verpackung nicht verwenden
    No lo use si el paquete está dañado
    Ne pas utiliser si le colis est endommagé
    Non utilizzare se la confezione è danneggiata
    Não use se o pacote estiver danificado
    Не используйте, если упаковка
    CE mark
    CE Zeichen
    Marca CE
    Marquage CE
    Marcatura CE
    Marca CE
    Знак соответствия продукции техническим
    регламентам ЕС
    Do not re-sterilize
    Nicht sterilisieren
    No volver a esterilizar
    Ne pas re-stériliser
    Non risterilizzare
    Não reesterilize
    Не стерилизуйте повторно
    Sterilized using irradiation
    Sterilisiert durch Bestrahlung
    Esterilizado mediante irradiación.
    Stérilisé par irradiation
    Sterilizzato con irradiazione
    Esterilizado por irradiação
    Стерилизовано с использованием
    Sterilized using ethylene oxide
    Sterilisiert mit Ethylenoxid
    Esterilizado con óxido de etileno.
    Stérilisé à l’oxyde d’éthylène
    Sterilizzato con ossido di etilene
    Esterilizado com óxido de etileno
    Стерилизовано окисидом этилена
    About the Test
    The Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus, severe acute
    respiratory syndrome coronavirus 2 (SARS-CoV-2)1
    . The SARS-CoV-2 is a β-coronavirus, which is an enveloped nonsegmented positive-sense RNA virus2
    . It is spread by human-to-human transmission via droplets or direct contact,
    and infection has been estimated to have a mean incubation period of 6.4 days and a basic reproduction number of
    2.24-3.58. Among patients with pneumonia caused by SARS-CoV-2, fever was the most common symptom, followed
    by cough3
    . The main IVD assays used for COVID-19 employ real-time reverse transcriptase-polymerase chain reaction
    (RT-PCR) that takes a few hours4
    . The availability of a cost-effective, rapid point-of-care diagnostic test is critical to
    enable healthcare professionals to aid in the diagnosis of patients and prevent further spread of the virus5
    . Antigen tests
    will play a critical role in the fight against COVID-196
    Test Principle
    Panbio™ COVID-19 Ag Rapid Test Device contains a membrane strip, which is pre-coated with immobilized antiSARS-CoV-2 antibody on the test line and mouse monoclonal anti-chicken IgY on the control line. Two types of
    conjugates (human IgG specific to SARS-CoV-2 Ag gold conjugate and chicken IgY gold conjugate) move upward
    on the membrane chromatographically and react with anti-SARS-CoV-2 antibody and pre-coated mouse monoclonal
    anti-chicken IgY respectively. For a positive result, human IgG specific to SARS-CoV-2 Ag gold conjugate and antiSARS-CoV-2 antibody will form a test line in the result window. Neither the test line nor the control line are visible in
    the result window prior to applying the patient specimen. A visible control line is required to indicate a test result is valid.
    Intended Use
    Panbio™ COVID-19 Ag Rapid Test Device is an in vitro diagnostic rapid test for the qualitative detection of SARSCoV-2 antigen (Ag) in human nasopharyngeal swab specimens from individuals who meet COVID-19 clinical and / or
    epidemiological criteria. Panbio™ COVID-19 Ag Rapid Test Device is for professional use only and is intended to be
    used as an aid in the diagnosis of SARS-CoV-2 infection. The product may be used in any laboratory and non-laboratory
    environment that meets the requirements specified in the Instructions for Use and local regulation.
    The test provides preliminary test results. Negative results don’t preclude SARS-CoV-2 infection and they cannot be
    used as the sole basis for treatment or other management decisions. Negative results must be combined with clinical
    observations, patient history, and epidemiological information. The test is not intended to be used as a donor screening
    test for SARS-CoV-2.
    Materials Provided
    • 25 Test devices with desiccant in individual foil pouch
    • Buffer (1 x 9 ml/bottle)
    • 25 Extraction tubes
    • 25 Extraction tube caps
    • 1 Positive control swab
    • 1 Negative control swab
    • 25 Sterilized nasopharyngeal swabs for sample collection
    • 1 Tube rack
    • 1 Quick reference guide (Nasopharyngeal)
    • 1 Instructions for use
    Materials Required but not Provided
    • Personal Protective Equipment, Timer, Biohazard container
    Active Ingredients of Main Components
    • 1 Test device
    Gold conjugate: Human IgG specific to SARS-CoV-2 Ag gold colloid and Chicken IgY – gold colloid, Test line:
    Mouse monoclonal anti-SARS-CoV-2, Control line: Mouse monoclonal anti-Chicken IgY
    • Buffer
    Tricine, Sodium Chloride, Tween 20, Sodium Azide (<0.1%), Proclin 300
    Storage and Stability
  11. The test kit should be stored at a temperature between 2-30 °C. Do not freeze the kit or its components.
    Note: When stored in a refrigerator, all kit components must be brought to room temperature (15-30 °C)
    for a minimum of 30 minutes prior to performing the test. Do not open the pouch while components come
    to room temperature.
  12. The Buffer bottle may be opened and resealed for each assay. The Buffer cap should be firmly sealed between
    each use. The Buffer is stable until expiration date if kept at 2-30 °C.
  13. Perform the test immediately after removing the test device from the foil pouch.
  14. Do not use the test kit beyond its expiration date.
  15. The shelf life of the kit is as indicated on the outer package.
  16. Do not use the test kit if the pouch is damaged or the seal is broken.
  17. Direct swab specimens should be tested immediately after collection. If immediate testing is not possible, the
    swab specimen can be kept in an extraction tube filled with extraction buffer (300 μl) at room temperature
    (15-30 °C) for up to two hours prior to testing.
  18. For in vitro diagnostic use only. Do not reuse the test device and kit components.
  19. These instructions must be strictly followed by a trained healthcare professional to achieve accurate results. All
    users have to read the instruction prior to performing a test.
  20. Do not eat or smoke while handling specimens.
  21. Wear protective gloves while handling specimens and wash hands thoroughly afterwards.
  22. Avoid splashing or aerosol formation of specimen and buffer.
  23. Clean up spills thoroughly using an appropriate disinfectant.
  24. Decontaminate and dispose of all specimens, reaction kits and potentially contaminated materials (i.e. swab,
    extraction tube, test device) in a biohazard container as if they were infectious waste and dispose according to
    applicable local regulations.
  25. Do not mix or interchange different specimens.
  26. Do not mix reagent of different lots or those for other products.
  27. Do not store the test kit in direct sunlight.
  28. To avoid contamination, do not touch the head of provided swab when opening the swab pouch.
  29. The provided sterilized swabs in the package should be used only for nasopharyngeal specimen collection.
  30. To avoid cross-contamination, do not reuse the sterilized swabs for specimen collection.
  31. Do not dilute the collected swab with any solution except for the provided extraction buffer.
  32. The buffer contains <0.1% sodium azide as a preservative which may be toxic if ingested. When disposed of
    through a sink, flush with a large volume of water.7
    Test Procedure (Refer to Figure)
    Nasopharyngeal Swab Specimens
    Note: Healthcare professionals should comply with personal safety guidelines including the use of personal protective
    Test Preparation
  33. Allow all kit components to reach a temperature between 15-30 °C prior to testing for 30 minutes.
  34. Remove the test device from the foil pouch prior to use. Place on a flat, horizontal and clean surface.
  35. Hold the buffer bottle vertically and fill the extraction tube with buffer fluid until it flows up to the Fill-line of
    the extraction tube (300 μl).
    Caution: If the amount of buffer is excessive or insufficient, an improper test result may occur.
  36. Place the extraction tube in the tube rack.
    Specimen Collection & Extraction
  37. Tilt the patient’s head back slightly about 45°-70° to straighten the passage from the front of the nose.
  38. Insert the swab with a flexible shaft through the nostril parallel to the palate.
    Caution: Use dedicated nasopharyngeal swab for specimen collection.
  39. Swab should reach depth equal to distance from nostrils to outer opening of the ear.
    Caution: If resistance is encountered during insertion of the swab, remove it and attempt insertion in the
    opposite nostril.
  40. Gently rub and roll the swab, 3-4 times. Leave the swab in place for several seconds to absorb secretions.
  41. Slowly remove swab while rotating it and insert into the extraction tube.
  42. Swirl the swab tip in the buffer fluid inside the extraction tube, pushing into the wall of the extraction tube at
    least five times and then squeeze out the swab by squeezing the extraction tube with your fingers.
  43. Break the swab at the breakpoint and close the cap of extraction tube.
    Reaction with Test Device
  44. Open the dropping nozzle cap at the bottom of the extraction tube.
  45. Dispense 5 drops of extracted specimens vertically into the specimen well (S) on the device. Do not handle or
    move the test device until the test is complete and ready for reading.
    Caution: Bubbles that occur in the extraction tube can lead to inaccurate results. If you are unable to create
    sufficient drops, this may be caused by clogging in the dispensing nozzle. Shake the tube gently to release the
    blockage until you observe free drop formation.
  46. Close the nozzle and dispose of the extraction tube containing the used swab according to your local regulations
    and biohazard waste disposal protocol.
  47. Start timer. Read result at 15 minutes. Do not read results after 20 minutes.
  48. Dispose of the used device according to your local regulations and biohazard waste disposal protocol.
    Positive / Negative Control Swab
  49. Hold the buffer bottle vertically and fill the extraction tube with buffer fluid until it flows up to the Fill-line of
    the extraction tube (300 μl).
    Caution: If the amount of buffer is excessive or insufficient, an improper test result may occur.
  50. Place the extraction tube in the tube rack.
  51. Insert the positive or negative control swab in the buffer fluid inside of the extraction tube and soak the swab
    for 1 minute. Swirl the control swab tip in the buffer fluid inside of the extraction tube, pushing into the wall of
    the extraction tube at least five times and then squeeze out the swab by squeezing the extraction tube with
    your fingers.
  52. Dispose of the used control swab in accordance with your biohazard waste disposal protocol.
  53. Close the cap of the extraction tube.
  54. Follow the above test procedure [Reaction with Test Device].
    Test Interpretation (Refer to Figure)
  55. Negative result: The presence of only the control line (C) and no test line (T) within the result window indicates
    a negative result.
  56. Positive result: The presence of the test line (T) and the control line (C) within the result window, regardless of
    which line appears first, indicates a positive result.
    Caution: The presence of any test line (T), no matter how faint, indicates a positive result.
  57. Invalid result: If the control line (C) is not visible within the result window after performing the test, the result
    is considered invalid.
    Test Limitations
  58. The contents of this kit are to be used for the professional and qualitative detection of SARS-CoV-2 antigen
    from nasopharyngeal swab. Other specimen types may lead to incorrect results and must not be used.
  59. Failure to follow the instructions for test procedure and interpretation of test results may adversely affect test
    performance and/or produce invalid results.
  60. A negative test result may occur if the specimen was collected, extracted or transported improperly. A negative
    test result does not eliminate the possibility of SARS-CoV-2 infection and should be confirmed by viral culture
    or a molecular assay or ELISA.
  61. Positive test results do not rule out co-infections with other pathogens.
  62. For further information on immune status, additional follow-up testing using other laboratory methods is
  63. Test results must be evaluated in conjunction with other clinical data available to the physician.
  64. Reading the test results earlier than 15 minutes or later than 20 minutes may give incorrect results.
  65. Panbio™ COVID-19 Ag Rapid Test Device is not intended to detect from defective (non-infectious) virus
    during the later stages of viral shedding that might be detected by PCR molecular tests.8
  66. Positive results may occur in cases of infection with >2.5 ng/mL SARS-CoV.
    Quality Control
  67. Internal Quality Control:
    The test device has a test line (T) and a control line (C) on the surface of the test device. Neither the test line nor the
    control line are visible in the result window before applying a specimen. The control line is used for procedural control and
    should always appear if the test procedure is performed properly and the test reagents of the control line are working.
  68. External Quality Control:
    The controls are specifically formulated and manufactured to ensure performance of the Panbio™ COVID-19 Ag Rapid
    Test Device and are used to verify the user’s ability to properly perform the test and interpret the results. The Positive
    Control will produce a positive test result and has been manufactured to produce a visible test line (T). The Negative
    Control will produce a negative test result.
    Good laboratory practice suggests the use of positive and negative controls to ensure that:
    • Test reagents are working, and
    • The test is correctly performed.
    Run the external controls under the following circumstances:
    • With each new operator prior to performing testing on patient specimens,
    • When receiving a new test shipment,
    • At periodic intervals as dictated by local, state and country requirements, and/or by the user’s Quality Control
    Performance Characteristics
  69. External evaluation of Panbio™ COVID-19 Ag Rapid Test Device
    Clinical performance of Panbio™ COVID-19 Ag Rapid Test Device was determined by testing 140 positive and
    445 negative specimens for SARS-CoV-2 antigen (Ag) to have a sensitivity of 91.4% (95% CI: 85.5-95.5%) and
    specificity of 99.8% (95% CI: 98.8-100%). Clinical specimens were determined to be positive or negative using an
    FDA EUA RT-PCR reference method.
    Panbio™ COVID-19 Ag Rapid Test Device Results
    PCR Test Result
    Positive Negative Total
    Panbio™ COVID-19 Ag
    Rapid Test Device Results
    Positive 128 1 129
    Negative 12 444 456
    Total 140 445 585
    Sensitivity Specificity Overall Percent
    • Performance data was calculated from a study of individuals suspected of exposure to COVID-19 or who
    have presented with symptoms in the last 7 days.
    • Stratification of the positive specimens post onset of symptoms or suspected exposure between 0-3 days
    has a sensitivity of 94.9% (n=39) and 4-7 days has a sensitivity of 90.1% (n=101).
    • Positive agreement of the Panbio™ COVID-19 Ag Rapid Test Device is higher with samples of Ct values
    ≤33 with a sensitivity of 94.1%. As suggested in References 8 and 9, patients with Ct value >33 are no
    longer contagious.8, 9
  70. Detection Limit
    Panbio™ COVID-19 Ag Rapid Test Device was confirmed to detect 2.5X101.8 TCID50/ml of SARS-CoV-2
    which was isolated from a COVID-19 confirmed patient in Korea.
  71. Hook Effect
    There is no hook effect at 1.0×105.8 TCID50/ml of SARS- CoV-2 which was isolated from a COVID-19
    confirmed patient in Korea.
  72. Cross Reactivity
    Cross-reactivity of Panbio™ COVID-19 Ag Rapid Test Device was evaluated by testing 25 viruses and 14
    other microorganisms. The final test concentrations of viruses and other microorganisms are documented
    in the Table below. The following viruses and other microorganisms except the Human SARS-coronavirus
    Nucleoprotein have no effect on the test results of Panbio™ COVID-19 Ag Rapid Test Device.
    Panbio™ COVID-19 Ag Rapid Test Device has cross-reactivity with Human -SARS-coronavirus
    Nucleoprotein at a concentration of 25 ng/ml or more because SARS-COV has high homologous (79.6%)
    to the SARS-COV-2.
    No. Types of
    Specimen Cross Reaction Substance Final Test Concentration Test Result
    Adenovirus Type3 2.0 X 106.5 TCID50/ml No cross reaction
    2 Adenovirus Type7 2.0 X 104.75 TCID50/ml No cross reaction
    3 Echovirus2 1.0 X 106.5 TCID50/ml No cross reaction
    4 Echovirus11 2.0 X105.25 TCID50/ml No cross reaction
    5 Human herpesvirus (HSV) 1 2.0 X 106.25 TCID50/ml No cross reaction
    6 Human herpesvirus (HSV) 2 2.0 X 104.75 TCID50/ml No cross reaction
    7 Mumps Virus Ag 2.0 X 103.5 TCID50/ml No cross reaction
    8 Influenza virus A (H1N1) Strain (A/Virginia/
    ATCC1/2009) 2.6 X 105.0 PFU/ml No cross reaction
    9 Influenza virus A (H1N1) Strain (A/WS/33) 5.0 X 107.25 TCID50/ml No cross reaction
    10 Influenza virus A(H3N2) Strain (A/Hong
    Kong/8/68) N/A* No cross reaction
    11 Influenza virus B Strain (B/Lee/40) 2.0 X 105.25 TCID50/ml No cross reaction
    12 Parainfluenza Type 1 N/A* No cross reaction
    13 Parainfluenza Type 2 N/A* No cross reaction
    14 Parainfluenza Type 3 N/A* No cross reaction
    15 Parainfluenza Type 4A 1.97 X 107.0 PFU/mL No cross reaction
    16 Respiratory syncytial virus (RSV) type A 4.22 X 105.0 TCID50/ml No cross reaction
    17 Respiratory syncytial virus (RSV) type B 5.62 X 105.0 TCID50/ml No cross reaction
    18 HCoV-HKU1 10 ug/ml No cross reaction
    19 Rhinovirus A16 8.8 X 105.0 PFU/mL No cross reaction
    20 HCoV-NL63 1.7 X 105.0 TCID50/ml No cross reaction
    21 HCoV-OC43 8.9 X 105.0 TCID50/ml No cross reaction
    22 HCoV-229E 1.51 X 106.0 TCID50/ml No cross reaction
    23 Human SARS-coronavirus Nucleoprotein 25 ng/ml Cross reaction
    24 MERS-CoV Nucleoprotein 0.25 mg/ml No cross reaction
    25 Human Metapneumovirus (hMPV) 16
    Type A1 1.06 X 106.0 PFU/mL No cross reaction
    Staphylococcus aureus 1.0 X 106.0 CFU/ml No cross reaction
    2 Staphylococcus saprophyticus 1.0 X 106.0 CFU/ml No cross reaction
    3 Neisseria sp.(Neisseria lactamica) 1.0 X 106.0 CFU/ml No cross reaction
    4 Escherichia coli 1.0 X 106.0 CFU/ml No cross reaction
    5 Staphylococcus haemolyticus 1.0 X 106.0 CFU/ml No cross reaction
    6 Streptococcus pyogenes 1.0 X 106.0 CFU/ml No cross reaction
    7 Streptococcus salivarius 1.0 X 106.0 CFU/ml No cross reaction
    8 Hemophilus parahaemolyticus 1.0 X 106.0 CFU/ml No cross reaction
    9 Proteus vulgaris 1.0 X 106.0 CFU/ml No cross reaction
    10 Moraxella catarrhalis 1.0 X 106.0 CFU/ml No cross reaction
    11 Klebsiella pneumoniae 1.0 X 106.0 CFU/ml No cross reaction
    12 Fusobacterium necrophorum 1.0 X 106.0 CFU/ml No cross reaction
    13 Mycobacterum tuberculosis 10 mg/ml No cross reaction
    14 Pooled human nasal wash N/A No cross reaction

Saliva easy test Invbio

The Invbio Covid (SARS-Cov-2) Antigen Rapid 25 Tests Device (Saliva) explained

Developped in 2021 this easy Corona virus (SARS-Cov2) Antigen Test Device, 25 tests a box on Saliva and sputum is an in vitro diagnostic test for the qualitative detection of covid antigens in human sputum and saliva, using the rapid immuno-chromatographic lateral flow method with a Genprice casette device. These casettes are disposable.

The identification is based on mouse monoclonal antibodies specific for the covid antigen. If you are anigen positive you are at risk to infect other people or animals like cats.

How does the saliva COVID-19 Rapid Test Device of Invbio works?

  1. One line on the C of control means negative
  2. Two lines one on the Ag and one on the control means positive
  3. No lines mean the test failed

Buy the not painful Antigen Rapid Test Devices for Saliva

  1. CE Mark and EUA for USA Emmergency Use Authorisation.
  2. Not FDA approved in februari 2021
  3. Relative sensitivity: 96.17 %
  4. Relative specificity: >99.9%
  5. Accuracy:98.79%%
  6. Specimen: Saliva, 10-20 minutes to get results
  7. perect for kids

Innovation Biotech (Beijing) Co.,Ltd is a biotechnology company specializing in research, development and manufacturing of advanced medical in-vitro diagnostic (IVD) rapid test kits, medical and laboratory disposal products. We provide one step medical diagnostic rapid test kit based on our INVBIO brand, Product include Fertility Tests, Infectious diseases, Tumor markers, DOA drug of abuse test, Drug test cup, Urinalysis reagent strip, ELISA kit, Digital alcohol tester, urine analyzer, et.

OEM packaging is available, drug of abuse test, troponin I test, alcohol screening saliva test strips, urine strips, elisa kits, microscope slides

Our focus is to expand our markets internationally by forming strategic alliances and entering into partnerships with distributors worldwide. We have established an international reputation for excellence in the manufacturing of quality medical and laboratory products. In addition, we have obtained approval licenses ISO13485, FSC certificate, and most of our products get CE mark Our objective is the utmost satisfaction of our clients all around the world by supplying our quality and economical products
It is the policy of Innovation Biotech (Beijing) Co., Ltd to achieve the highest degree of product quality, we ensuring that processes and services are continually improved in line with customer requirements.

Abbott’s $25 Rapid Virus Test Cleared for At-Home Use

Abbott’s $25 Rapid Virus Test Cleared for At-Home Use

Abbott Laboratories gained U.S. authorization for a speedy Covid-19 check that prices $25 and can be utilized at residence, a brand new accessible choice from the producer after months of obstacles to screening entry within the nation.

The emergency clearance from the Food and Drug Administration opens a brand new market for Abbott’s BinaxNOW, a single-use swab-collected check that produces leads to 15 minutes. Until now, the check had been administered by health-care suppliers. Abbott is partnered with a service to remotely prescribe the screening.

The U.S. authorities bought a lot of Abbott’s BinaxNow provide after the check was first approved by regulators in late August. The firm plans to make 30 million exams obtainable for at-home use within the first quarter of subsequent yr and 90 million extra within the second quarter.

Patients can order the check by means of the Abbott-developed Navica smartphone app, the place they are going to fill out a collection of well being questions. Abbott’s prescribing companion, eMed, ships the check and just about supervises its administration. Results are then delivered by means of the Navica app.

Although the necessity for speedy testing has risen in the course of the pandemic, “sadly, we’re nonetheless listening to that many individuals can’t entry testing as rapidly as they want it,” Robert Ford, Abbott’s chief government officer, mentioned in a press release.

The new providing “permits us to take care of the integrity of the testing course of, get even nearer to individuals who want testing and assist present the boldness we have to assist get again to residing with a bit extra normalcy,” he mentioned.

In an ongoing examine of 52 individuals who used the at-home providing inside per week of growing signs, the check precisely produced optimistic outcomes about 92% of the time, and appropriately returned damaging exams 100% of the time, the corporate mentioned. The check was particularly correct for a subset of sufferers who have been extra more likely to be infectious, in keeping with Abbott, producing true positives in 100% of circumstances

The Abbott information follows the FDA’s clearance of the primary at-home, over-the-counter Covid-19 check on Tuesday from East Brisbane, Australia-based Ellume. Ellume will promote its speedy check in pharmacies and on-line for about $30, with plans to fabricate 100,000 a day beginning in January.

Abbott’s $25 Rapid Virus Test Cleared for At-Home Use

FDA Clears First At-Home, Over-the-Counter Covid-19 Test (1)

Testing has been a key line of protection in opposition to the virus, but it surely has additionally been onerous to entry at occasions. People seeking to get examined have typically confronted gradual turnaround occasions, excessive prices and lengthy traces, which presents specific challenges when folks with out signs could also be infectious.

Public-health specialists have referred to as for making screening extra accessible and criticized the FDA for transferring too slowly on green-lighting new functions. While at-home choices are a step ahead, decrease costs and extra widespread entry are nonetheless wanted, some specialists have mentioned.

Medical Setting

The overwhelming majority of U.S. Covid-19 exams are carried out in a medical setting and require a supplier’s authorization, together with an at-home check from Lucira Health Inc. cleared by the FDA final month. Last week, the company cleared a check from Laboratory Corp of America Holdings that doesn’t require medical authorization however should bear lab processing.

One of the priorities for regulators round at-home testing has been guaranteeing that it’s straightforward for the general public to make use of and that outcomes are reported to public-health officers.

Abbott companion eMed, led by former American Medical Association president Patrice Harris, will determine on customers’ eligibility for the check, information them by means of the screening course of and conduct public-health reporting.

Abbott, which sells BinaxNOW for $5, mentioned the $25 value will embrace each the check and eMed’s providers.