SARS-COV-2 identification – an overview of the commercially available reagents

Severe acute respiratory syndrome coronavirus two abbreviated as SARS-CoV-2 is the virus responsible for the coronavirus disease of 2019 (COVID-19). It was first detected in Wuhan (China) in December 2019. The World Health Organization announced the disease as a pandemic in March 2020. The genome size ranges between 27 and 34 kilobases which is larger than most RNA viruses. This novel coronavirus is a part of the Beta-coronavirus genus and causes acute respiratory distress. The virus can be transmitted mainly through close contact and respiratory droplets during sneezing, coughing. Along with other respiratory pathogen, the coronavirus can infect more easily other people at lower temperatures. SARS-CoV-2 enters the cells via the endocytosis and uses surface spike proteins to bind the angiotensin-converting receptor 2(ACE-2) and dipeptidyl peptidase 4 (dpp4) receptors on the ciliated bronchial epithelial cells and type II pneumocytes, respectively. These polyproteins are cleaved to produce components to its RNA complex which is responsible for transcription and viral RNA replication. Nucleocapsids are included in the coronavirus virions and then the new viral particles can leave the host cell via exocytosis, completing the replication cycle.

How can the coronavirus be transmitted?

Transmission of the virus can occur also through contact with contaminated surfaces. The viral particles may survive on stainless steel and plastics for up to 72 hours after application. Incubation periods after exposure to the novel coronavirus vary between 1 and 14 days but the first symptoms can occur within 4-5 days up to 11 days.

The identification of SARS-COV-2 is mainly performed by Real-Time Reverse Transcription Polymerase chain reaction (rRT-PCR) on respiratory and blood samples. Positive results show active infection with 2019-nCoV but do not exclude bacterial infection or co-infection with other viruses. Negative results do not make impossible the 2019-nCoV infection and cannot not be used as the only basis for treatment. These results must be reviewed together with the clinical symptoms, patient history, and epidemiological information. Along with the RT-PCR analysis, many companies developed immunochromatographic tests for fast detection of IgM and IgG in whole, blood serum and plasma.

Which kits you can find on the market?

Here we present you a brief overview of the commercially available kits, reagents and consumables for detection of COVID-19 that are used worldwide for clinical diagnosis and epidemiological research:

AccuBioTech Co. Ltd Accu-Tell COVID-19 IgG/IgM Rapid Test Cassette (CE-IVD)

Alfa Scientific Designs Inc. DrivenFlow COVID-19 (CE-IVD)

AmonMed Biotechnology Co., Ltd COVID-19 IgM/IgG test kit (Rare Earth Nano Fluorescence Immunochromatography) (CE-IVD)

AmonMed Biotechnology Co., Ltd COVID-19 IgM/IgG test kit (Colloidal Gold) (CE-IVD)

AmonMed Biotechnology Co., Ltd COVID-19 Antigen Test Kit (Rare Earth Nano Fluorescence Immunochromatography) (CE-IVD) 

AmonMed Biotechnology Co., Ltd COVID-19/Influenza A virus/Influenza B virus IgM combo test kit

(Rare Earth Nano Fluorescence Immunochromatography) (CE-IVD)

AmonMed Biotechnology Co., Ltd COVID-19/Influenza A virus/Influenza B virus test kit (Rare Earth

Nano Fluorescence Immunochromatography) (CE-IVD)

Anomalous Materials Pte Ltd 2019-nCoV IgG/IgM Rapid Testing Kit (CE-IVD)

Assure Tech. (Hangzhou) Co., Ltd COVID-19 IgG/IgM Rapid Test Device (CE-IVD) 

Beijing Abace Biology Co., Ltd COVID-19 IgM Antibody Test Kit (ELISA) (CE-IVD)

 Beijing Abace Biology Co., Ltd COVID-19 Viral Antigen Test Kit (Colloidal Gold Immunochromatography) (CE-IVD)

Beijing Abace Biology Co., Ltd COVID-19 Viral Antigen Test Kit (ELISA) (CE-IVD) 

Beijing Abace Biology Co., Ltd COVID-19 IgG Antibody Test Kit (ELISA) (CE-IVD) 

Beijing Abace Biology Co., Ltd COVID-19 Antibody (IgG/IgM)Test Kit (Colloidal Gold Immunochromatography) (CE-IVD)

Beijing Diagreat Biotechnologies Co., Ltd 2019-nCoV IgG Antibody Determination Kit (CE-IVD)

Beijing Diagreat Biotechnologies Co., Ltd 2019-nCoV IgM Antibody Determination Kit (CE-IVD)

Beijing Kewei Clinical Diagnostic Reagent Inc. Kewei COVID-19 Antigen Rapid Test Kit (Colloidal Gold) (CE-IVD)

Beijing Kewei Clinical Diagnostic Reagent Inc. Kewei COVID-19 Antigen Rapid Test Kit (Fluorescence) (CE-IVD)

Beijing Kewei Clinical Diagnostic Reagent Inc. Kewei COVID-19 IgG ELISA Test Kit (CE-IVD)

Beijing Kewei Clinical Diagnostic Reagent Inc. Kewei COVID-19 IgG/IgM Rapid Test Kit (Colloidal

Gold) (CE-IVD)

Beijing Kewei Clinical Diagnostic Reagent Inc. Kewei COVID-19 IgG/IgM Rapid Test Kit (Fluorescence) (CE-IVD)

Beijing Kewei Clinical Diagnostic Reagent Inc. Kewei COVID-19 IgM ELISA Test Kit (CE-IVD)

Beijing Savant Biotechnology Co., Ltd SARS-Cov-2 Antigen Fluorescence Rapid Detection Kit (CE- IVD) 

Beijing Tigsun Diagnostics Co. Ltd Tigsun COVID-19 Combo IgM/IgG Rapid Test (Lateral Flow Method) (CE-IVD)

BIOHIT HealthCare (Hefei) Co., Ltd SARS-CoV-2 IgM/IgG antibody test kit (Colloidal Gold Method) (CE-IVD)

BIOMAXIMA S.A. 2019-nCoV IgG/IgM Rapid Test Cassette (CE-IVD)

BioMedomics, Inc. COVID-19 IgM-IgG Dual Antibody Rapid Test (CE-IVD)

Cellex Inc. Cellex qSARS-CoV-2 IgGIgM Cassette Rapid Test (US FDA-EUA – CE-IVD)

 Changsha Sinocare Inc. SARS-CoV-2 Antibody Test Strip (Colloidal Gold Method) (CE-IVD) 

Core Technology Co., Ltd COVID-19 IgM/IgG Ab Test (CE-IVD)  1  2

Coris BioConcept COVID-19 Ag Respi-Strip (CE-IVD)

DRG International, Inc. COVID-19 lgM, EIA-6147 (CE-IVD)

DRG International, Inc. COVID-19 lgG, EIA-6146 (CE-IVD) 

Dynamiker Biotechnology (Tianjin) Co., Ltd. 2019 nCOV IgG/IgM Rapid Test (CE-IVD)

Edinburgh Genetics Limited 2019 nCoV novel coronavirus antibody detection reagent (Colloidal gold) (CE-IVD)

Epitope Diagnostics, Inc. EDI™ Novel Coronavirus COVID-19 IgG ELISA Kit (CE-IVD)  Epitope Diagnostics, Inc. EDI™ Novel Coronavirus COVID-19 IgM ELISA Kit (CE-IVD)

 EUROIMMUN AG Anti-SARS-CoV-2 ELISA (IgA) (manual, automated) (CE-IVD) 

EUROIMMUN AG Anti-SARS-CoV-2 ELISA (IgG) (manual, automated) (CE-IVD) 

GenBody, Inc. GenBody COVID-19 IgM/IgG (CE-IVD)

Getein Biotech, Inc. One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG Antibody (Colloidal Gold) (CE-IVD)

Goldsite Diagnostics Inc. SARS-CoV-2 IgG/IgM Kit (manual) (CE-IVD)

Hanghzhou AllTest Biotech Co., Ltd 2019-nCoV IgG/IgM Rapid Test Cassette (CE-IVD)

Hangzhou Biotest Biotech Co., Ltd COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) (CE-IVD)

Humasis Humasis COVID-19 IgG/IgM Test (Korea MFDS – CE-IVD) 

Hunan Lituo Biotechnology Co., Ltd COVID-19 IgG/IgM Detection Kit (Colloidal Gold) (CE-IVD)

Innovita Biological Technology Co. Ltd 2019-nCoV Ab Test (Colloidal Gold) (IgM/IgG Whole Blood/Serum/Plasma Combo) (CE-IVD)

InTec Products, Inc. Rapid SARS-CoV-2 Antibody (IgM/IgG) (CE-IVD)  1  2

InTec Products, Inc. Rapid SARS-CoV-2 Antibody Test (CE-IVD)  1  2

Jiangsu Bioperfectus Technologies Co. Ltd PerfectPOC Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit (CE-IVD)

Jiangsu Bioperfectus Technologies Co. Ltd PerfectPOC Novel Corona Virus (SARS-CoV-2) IgM/IgG Rapid Test Kit (CE-IVD)

Liming Bio-Products Co., Ltd COVID-19 IgG/IgM Combo Rapid Test Device (CE-IVD)

Liming Bio-Products Co., Ltd COVID-19 Antigen Rapid Test Device (CE-IVD)

Liming Bio-Products Co., Ltd COVID-19 IgG/IgM Combo Rapid Test Device (CE-IVD)

LOMINA AG SARS-CoV-2(COVID19)IgM/IgG Antibody Fast Detection Kit (CE-IVD) 

LumiQuick Diagnostics Inc. QuickProfile™ 2019-nCoV IgG/IgM Combo Test Card (CE-IVD)

MedicalSystem Biotechnology Co., Ltd COVID-19 IgM/IgG Rapid Test Cassette (CE-IVD)

Mokobio Biotechnology R&D Center SARS-CoV-2 IgM & IgG Quantum Dot Immunoassay (CE-IVD)

nal von minden GmbH NADAL COVID-19 IgG/IgM Test (243003N-25, 243002N-20, 243001N-10) (CE-IVD)

Nantong Egens Biotechnology Co., LTD EGENS COVID-19 IgG/IgM Rapid Test Kit (CE-IVD – RUO)

PCL Inc. PCL COVID19 IgG/IgM Rapid Gold (Korea MFDS – CE-IVD) 

PCL Inc. PCL COVID19 Ag Rapid FIA (CE-IVD)

PEPperPRINT GmbH  PEPperCHIP SARS-CoV-2 Proteome Microarray (manual) (CE-IVD)

PerGrande BioTech Development Co., Ltd SARS-CoV-2 Antibody Detection Kit (Colloidal Gold

Immunochromatographic assay) (CE-IVD) 

RayBiotech  Coronavirus (SARS-CoV-2) IgM/IgG Test Kit (Colloidal Gold) (CE-IVD)

SO BIOSENSOR, Inc.  STANDARD Q COVID-19 IgM/IgG Duo Test (CE-IVD)

SO BIOSENSOR, Inc.  STANDARD Q COVID-19 Ag Test (CE-IVD)

SO BIOSENSOR, Inc.  STANDARD F COVID-19 Ag FIA (CE-IVD)

SensingSelf, Pte, Ltd, Singapore EDR COVID 19 Rapid Test Kit (IgM/IgG) (CE-IVD)

servoprax GmbH Cleartest Corona, Covid-19 (CE-IVD)  1  2

Shanghai Chemtron Biotech Co. Ltd 2019-nCoV IgM Antibody Diagnostic Kit (Colloidal gold) (CE- IVD) 

Shenzhen Bioeasy Biotechnology Co., Ltd Bioeasy 2019-nCoV Ag Fluorescence Rapid Test Kit

(Time-Resolved Fluorescence) (CE-IVD)

Shenzhen Bioeasy Biotechnology Co., Ltd Bioeasy 2019-nCoV Total Ab GICA Rapid Test (CE-IVD)

Shenzhen Tailored Medical Ltd Novel Coronavirus (SARS-CoV-2) IgM/IgG Antibody Assay Kit

(Colloidal Gold Method) (CE-IVD)

Shenzhen Yhlo Biotech Co. Ltd iFlash-SARS-CoV-2 IgG (CE-IVD)

Shenzhen Yhlo Biotech Co. Ltd iFlash-SARS-CoV-2 IgM (CE-IVD)

Snibe Co., Ltd (Shenzhen New Industries Biomedical Engineering Co., Ltd) MAGLUMI 2019- nCoV IgM (CLIA) (CE-IVD)

Snibe Co., Ltd (Shenzhen New Industries Biomedical Engineering Co., Ltd) MAGLUMI 2019- nCoV IgG (CLIA) (CE-IVD)

Sugentech, Inc. SGTi-flex COVID-19 IgM/IgG (manual) (CE-IVD)  Sugentech, Inc. SGTi-flex COVID-19 IgG (RDT) (CE-IVD) 

Sugentech, Inc. SGTi-flex COVID-19 IgM/IgG (manual) (CE-IVD) 

Sugentech, Inc. SGTi-flex COVID-19 IgM (manual) (CE-IVD)  Sugentech, Inc. SGTi-flex COVID-19 IgM (RDT) (CE-IVD) 

Sugentech, Inc. SGTi-flex COVID-19 IgM/IgG (RDT) (CE-IVD)

Sure Bio·Tech (USA) Co., Ltd  SARS-CoV-2 IgM Ab Rapid Test (CE-IVD) 

Sure Bio·Tech (USA) Co., Ltd  SARS-CoV-2 IgM/IgG Ab Rapid Test (CE-IVD)  Sure Bio·Tech (USA) Co., Ltd  SARS-CoV-2 IgG Ab Rapid Test (CE-IVD) 

Taizhou ZECEN Biotech Co., Ltd SARS-CoV-2 IgG (CE-IVD)

Taizhou ZECEN Biotech Co., Ltd SARS-CoV-2 IgM (CE-IVD)

Tianjin MNCHIP Technologies Co., Ltd Anti-COVID-19 virus IgM/IgG rapid test kit (Colloidal gold assay) (CE-IVD)

Tianjin MNCHIP Technologies Co., Ltd. Anti-COVID-19 virus IgM/IgG rapid test kit (Colloidal gold assay) (CE-IVD)

VivaChek Biotech (Hangzhou) Co., Ltd  VivaDiag COVID-19 IgM/IgG Rapid Test (CE-IVD) 

VivaChek Biotech (Hangzhou) Co., Ltd  VivaDiag COVID-19 Antigen Rapid Test (CE-IVD) 

Wuhan EasyOiagnosis Biomedicine Co., Ltd Novel Coronavirus IgM antibody test kit (colloidal gold method) (CE-IVD)

Wuhan EasyOiagnosis Biomedicine Co., Ltd Novel Coronavirus IgG antibody test kit (colloidal gold method) (CE-IVD) 

Wuhan EasyDiagnosis Biomedicine Co.,Ltd Novel Coronavirus IgM antibody test kit (colloidal gold method) (CE-IVD)

Wuhan EasyDiagnosis Biomedicine Co.,Ltd Novel Coronavirus IgG antibody test kit (colloidal gold method) (CE-IVD)

Xiamen Biotime Biotechnology Co., Ltd SARS-CoV-2 IgG/IgM Rapid Qualitative Test Kit (CE-IVD)

Xiamen Boson Biotech Co. Ltd Rapid 2019-nCoV IgG/IgM Combo Test Card (CCE-IVD) 

Xiamen Wiz Biotech Co. Ltd Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-COV-2(CE-IVD)

Yuno Diagnostics Co., Ltd Novel coronavirus(SARS-CoV-2) IgG/IgM Antibody Combined Test Kits(CE-IVD)

Zhejiang Gene Science Co., Ltd  Novel Coronavirus (2019-nCoV) IgM/IgG Antibodies Detection Kit (CE-IVD)

 We cannot guarantee that all products for detection of the novel coronavirus are included in the list. For any additional questions, updates or latest news observed with the methods for identification of COVID-19, our specialists will be happy to assist you.