Panbio Abbott Covid test

About the Test

Introduction

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.

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.
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.
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
kit.
Revise la fecha de vencimiento de la caja del kit.
Si la fecha de vencimiento ha pasado, use otro
kit.
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
patient.
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
Folgendem:

Testergebnislesefenster

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

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
paciente.
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.
PREPARATION / VORBEREITUNG / PREPARACIÓN / PREPARATION / PREPARAZIONE
/ PREPARAÇÃO / ПОДГОТОВКА
: 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
TEST INTERPRETATION / TEST INTERPRETATION / INTERPRETACIÓN DE LA PRUEBA / INTERPRETATION DU TEST /
INTERPRETAZIONE DEL TEST / INTERPRETAÇÃO DE TESTE / ИНТЕРПРЕТАЦИЯ ТЕСТА
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.
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
positif.
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
результате.
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
positivo.
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
41FK10-07-A0
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.
POSITIVE / POSITIV / POSITIVA / POSITIF / POSITIVO / POSITIVO / ПОЛОЖИТЕЛЬНЫЙ
INVALID / UNGÜLTIG / NO VÁLIDA / INVALIDE / INVALIDO / INVÁLIDO / НЕВЕРНЫЙ РЕЗУЛЬТАТ
6 7 8 9 Open the
dropping nozzle
cap at the bottom
of the extraction
tube.
Abra la tapa de
la boquilla de
goteo en la parte
inferior del tubo
de extracción.
Aprire il tappo
dell’ugello
posizionato nella
parte inferiore
della provetta di
estrazione.
Откройте крышку
колпачка –
капельницы в
нижней части
экстракционной
пробирки.
Öffnen Sie die Kappe
der Dosieröffnung
am Boden des
Extraktionsröhrchens.
Ouvrez le
capuchon de la
buse à goutte
au bas du tube
d’extraction.
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
minutos.
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
считыванию.
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.
TEST PROCEDURE / TESTVERFAHREN / PROCEDIMIENTO DE LA PRUEBA / PROCEDURE / PROCEDURA DEL TEST / PROCEDIMENTO DE TESTE / ПРОЦЕДУРА ТЕСТИРОВАНИЯ
5 x
Close the nozzle
and dispose of the
extraction tube
containing the used
swab according to your
local regulations and
biohazard waste disposal
protocol.
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
biologici.
Закройте колпачоккапельницу, и утилизируйте
экстракционную
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
biologiques.
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
biológico.

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
suivants
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
(nasopharyngé)
Notice d’utilisation
Откройте упаковку и проверьте комплектность:
Тест-кассета в индивидуальной вакуумной упаковке с
осушителем
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
Probenahme
Ständer für Röhrchen
Kurzanleitung (Nasopharyngeal)
Gebrauchsanweisung
Aprire la confezione e cercare quanto segue:
Dispositivo di test confezionato
singolarmente in busta di alluminio con
essiccante
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
(Nasofaringeo)
Istruzioni per l’uso
Abra el paquete y revise los siguientes
componentes:
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)

I
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
biológico.
Smaltire il dispositivo
usato in base alle
normative locali
e al protocollo di
smaltimento dei rifiuti
biologici.
Использованную тесткассету утилизируют
в соответствии с
местными правилами и
протоколом утилизации
биологически опасных
отходов.
Entsorgen Sie
die gebrauchte
Testkassette gemäß
den örtlichen
Vorschriften und dem
Entsorgungsprotokoll
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.
EN
PT
RU
FR
DE
ES
IT
Nr. Art der Probe Kreuzreaktionssubstanz Finale Testkonzentration Testergebnis
1
Andere
Mikroorganismen
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.

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
1
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
8
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
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
1
Autre
Microorganisme
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.

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
1
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
8
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
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
1
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.
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
1
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
8
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
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
1
Otros
Microorganismos
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.

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
1
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
8
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
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
1
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.

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
1
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
8
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
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
1
Другой
микроорганизм
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.
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
1
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
8
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
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.
In Vitro Diagnostic Assays for COVID-19: Recent Advances and Emerging Trends (Sandeep Kumar Vashist, 2020 April
05: diagnostics)
Nano Research for COVID-19 (http://dx.doi.org/10.1021/acsnano.0c02540)
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
Current Intelligence Bulletin 13: Explosive Azide Hazard DHHS (NIOSH) Publication Number 78-127 August 16, 1976
CDC. Discontinuation of Transmission-Based Precautions and Disposition of Patients with COVID-19 in Healthcare
Settings (Interim Guidance). (2020).
CDC. Duration of Isolation and Precautions for Adults with COVID-19. (2020).
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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
(300μL).
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
мкл).
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
produire.
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
(300μL).
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
estrazione.
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.
Тампон
разламывают в
точке разлома,
и колпачок
для пробирки
экстракционной
закрывают.
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
Extraktionssröhrchens.
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
l’écouvillon.
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
rack.
Coloque el tubo
de extracción
en la gradilla
para tubos.
Posizionare
la provetta
di estrazione
nel rack
portaprovette.
Установите
экстракционную
пробирку в
штатив.
Stellen Sie das
Extraktionsröhrchen
in den
Röhrchenständer.
Placez le tube
d’extraction
dans le support
de tubes.
Coloque o tubo
de extração
no suporte de
tubos.
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
minutes.
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
individuelle.
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
einhalten.
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.

GLOSSARY OF SYMBOLS / SYMBOLVERZEICHNIS / GLOSARIO DE SÍMBOLOS / GLOSSAIRE DES SYMBOLES / GLOSSARIO DEI SIMBOLI
/ GLOSSÁRIO DE SÍMBOLOS / ГЛОССАРИЙ ОБОЗНАЧЕНИЙ
Temperature limitation
Temperaturbegrenzung
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
Herstellungsdatum
Fecha de manufactura
Date de fabrication
Data di produzione
Data de fabricação
Дата производства
Catalog Number
Artikelnummer
Número de catalogo
Numéro de catalogue
Numero di catalogo
Número no Catálogo
Каталожный номер
Lot Number
Chargencode
Número de lote
Numéro de lot
Numero di lotto
Número de Lote
Номер серии
Manufacturer
Hersteller
Fabricante
Fabricant
Produttore
Fabricante
Производитель
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
повреждена
Caution
Achtung
Precaución
Attention
Attenzione
Cuidado
Предупреждение
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
облучения
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
DRAFT
About the Test
Introduction
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
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.
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.
Perform the test immediately after removing the test device from the foil pouch.
Do not use the test kit beyond its expiration date.
The shelf life of the kit is as indicated on the outer package.
Do not use the test kit if the pouch is damaged or the seal is broken.
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.
Warnings
For in vitro diagnostic use only. Do not reuse the test device and kit components.
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.
Do not eat or smoke while handling specimens.
Wear protective gloves while handling specimens and wash hands thoroughly afterwards.
Avoid splashing or aerosol formation of specimen and buffer.
Clean up spills thoroughly using an appropriate disinfectant.
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.
Do not mix or interchange different specimens.
Do not mix reagent of different lots or those for other products.
Do not store the test kit in direct sunlight.
To avoid contamination, do not touch the head of provided swab when opening the swab pouch.
The provided sterilized swabs in the package should be used only for nasopharyngeal specimen collection.
To avoid cross-contamination, do not reuse the sterilized swabs for specimen collection.
Do not dilute the collected swab with any solution except for the provided extraction buffer.
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
equipment.
Test Preparation
Allow all kit components to reach a temperature between 15-30 °C prior to testing for 30 minutes.
Remove the test device from the foil pouch prior to use. Place on a flat, horizontal and clean surface.
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.
Place the extraction tube in the tube rack.
Specimen Collection & Extraction
Tilt the patient’s head back slightly about 45°-70° to straighten the passage from the front of the nose.
Insert the swab with a flexible shaft through the nostril parallel to the palate.
Caution: Use dedicated nasopharyngeal swab for specimen collection.
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.
Gently rub and roll the swab, 3-4 times. Leave the swab in place for several seconds to absorb secretions.
Slowly remove swab while rotating it and insert into 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.
Break the swab at the breakpoint and close the cap of extraction tube.
Reaction with Test Device
Open the dropping nozzle cap at the bottom of the extraction tube.
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.
Close the nozzle and dispose of the extraction tube containing the used swab according to your local regulations
and biohazard waste disposal protocol.
Start timer. Read result at 15 minutes. Do not read results after 20 minutes.
Dispose of the used device according to your local regulations and biohazard waste disposal protocol.
Positive / Negative Control Swab
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.
Place the extraction tube in the tube rack.
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.
Dispose of the used control swab in accordance with your biohazard waste disposal protocol.
Close the cap of the extraction tube.
Follow the above test procedure [Reaction with Test Device].
Test Interpretation (Refer to Figure)
Negative result: The presence of only the control line (C) and no test line (T) within the result window indicates
a negative result.
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.
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
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.
Failure to follow the instructions for test procedure and interpretation of test results may adversely affect test
performance and/or produce invalid results.
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.
Positive test results do not rule out co-infections with other pathogens.
For further information on immune status, additional follow-up testing using other laboratory methods is
recommended.
Test results must be evaluated in conjunction with other clinical data available to the physician.
Reading the test results earlier than 15 minutes or later than 20 minutes may give incorrect results.
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
Positive results may occur in cases of infection with >2.5 ng/mL SARS-CoV.
Quality Control
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.
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
procedures.
Performance Characteristics
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
Agreement
91.4%
[85.5%;95.5%]
99.8%
[98.8%;100%]
97.8%
[96.2%;98.8%]
• 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
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.
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.
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
1
Virus
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
1
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
13 Mycobacterum tuberculosis 10 mg/ml No cross reaction
14 Pooled human nasal wash N/A No cross reaction