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EZER Flu & COVID-19 Antigen Duo (For Self-Testing)

CE 1434

The EZERTM Flu & COVID-19 Antigen Duo Rapid Test is a lateral flow immunoassay intended for the in vitro rapid, simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from nasal swab specimens obtained from individuals, who are suspected of respiratory viral infection, within the first three days of onset of symptoms. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar.


Product Detail

Introduction

The EZERTM Flu & COVID-19 Antigen Duo Rapid Test is a lateral flow immunoassay intended for the in vitro rapid, simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from nasal swab specimens obtained from individuals, who are suspected of respiratory viral infection, within the first three days of onset of symptoms. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. These viral antigens are generally detectable in nasal swab samples during the acute phase of 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.

Results are for the simultaneous identification of nucleocapsid antigens of SARS-CoV-2, influenza A and influenza B, but does not differentiate between SARS-CoV and SARS-CoV-2 viruses.

Detection

EZERTM Flu & COVID-19 Antigen Duo Rapid Test is the simultaneous qualitative detection and differentiation of the nucleocapsid protein antigens from SARS-CoV-2, influenza A and influenza B in nasal swab specimens

Specimen

Nasal swab

Limit of Detection (LoD)

SARS-CoV-2: 140 TCID50/mL

Influenza A

Influenza Viral Strain Calculated LOD (TCID 50 /mL)
A/New Caledonia/20/1999_H1N1  4.25x103
A/California/04/2009_H1N1 2.11x103
A/PR/8/34_H1N1 7.31x102
A/Bean Goose/Hubei/chenhu XVI35-1/2016_H3N2  2.47x102
A/Guizhou/54/89_H3N2  1.98x102
A/Human/Hubei/3/2005_H3N2  1.46x104
A/Bar-headed Goose/QH/BTY2/2015_H5N1 9.88x104
A/Anhui/1/2013_H7N9 1.98x105

Influenza B

Influenza Viral Strain Calculated LOD
(TCID 50 /mL)
B52-Victoria  39.5
B5-Yamagata  5.31x102

Accuracy

Influenza A Influenza B COVID-19
Relative Sensitivity 88.7% 86.6% 97.2%
Relative Specificity 99.6% 99.4% 99.4%

Time to results

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

Kit storage conditions

2~30°C. 

Contents

Test device

Sterilized swab

Extraction buffer tube (with extraction buffer)

Package insert

Ordering Information

Product Cat.No. Contents
EZERTM Flu & COVID-19 Antigen Duo Rapid Test
P213106 1 Test
P213107 5 Tests
P213109 20 Tests

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