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EZER COVID-19 Antigen (For Self-testing)

CE 1434

The EZERTM COVID-19 Antigen Rapid Test is a rapid, lateral flow immunochromatography assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal swab specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection.


Product Detail

Introduction

The EZERTM COVID-19 Antigen Rapid Test is a rapid, lateral flow immunochromatography assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal swab specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection.

This test is for laymen with self-collected nasal (nares) swab samples from individuals aged 14 years or older, or adult collected nasal swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.

The EZERTM COVID-19 Antigen Rapid Test does not differentiate between SARS-CoV and SARS-CoV-2.

Detection

The qualitative detection of nucleocapsid protein antigens from SARS-CoV-2 in nasal swab.

Specimen

Nasal swab

Limit of Detection (LoD)

SARS-CoV-2: 140 TCID50/mL

Accuracy

Sensitivity: 98.0%

Specificity: 99.4%

Overall Accuracy: 98.9%

Time to results

Read results at 15minutes and no more than 30 minutes.

Kit storage conditions

2~30°C. 

Contents

Test device

Sterilized swab

Extraction tube (with extraction buffer)

Package insert 

Ordering Information

Product Cat.No. Contents
EZER COVID-19 Antigen Rapid Test (For Self-testing) P213104  1 Test
P213105 5 Tests
P213108 20 Tests

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