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EZER Flu&COVID-19 Antigen Combo Rapid Test

EZER Flu&COVID-19 Antigen Combo Rapid Test is intended for the simultaneous qualitative detection and differentiation of the nucleocapsid protein antigens from SARS-CoV-2, influenza A and influenza B in direct nasal specimens. The detection is based on the antibodies which were developed specifically recognizing and reacting with the nucleoprotein of virus.


Product Detail

Introduction

Influenza virus belongs to the family of Orthomyxoviridae, and immunologically diverse, single-stranded RNA viruses. There influenza A and B virus is the main pathogen that severe illnesses both in human and in many animal species. Based on the current epidemiological investigation, the incubation period is 1 to 4 days. The main manifestations include acute fever, general aching and respiratory symptoms. Both Type A and B viruses can circulate simultaneously, but usually one type is dominant during a given season.

COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. SARS-CoV-2, influenza A and influenza B viral antigens are generally detectable in upper respiratory specimens during the acute phase of infection.

The EZERTM Flu&COVID-19 Antigen Combo Rapid Test includes influenza antigen rapid test and COVID-19 antigen rapid test, is an immunochromatographic assay for the qualitative detection of 2019 Novel Coronavirus, influenza A and B antigens. The EZERTM Flu&COVID-19 Antigen Combo Rapid Test has four letters on the surface of the strips indicating test line (S)﹑ (A)﹑ (B) and control line (C).

Detection

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

Specimen

Nasal

Limit of Detection (LoD)

Flu&COVID-19 :140 TCID50/mL

The minimum detection limit of Flu A for the EZERTM Flu&COVID-19 Antigen Combo Rapid Test was established based on a total of 8 influenza A.

Influenza Viral Strain

Calculated LoD
(TCID50/mL)

A/New Caledonia/20/1999_H1N1

8.50x103

A/California/04/2009_H1N1

2.11x103

A/PR/8/34_H1N1

2.93x103

A/Bean Goose/Hubei/chenhu XVI35-1/2016_H3N2

4.94x102

A/Guizhou/54/89_H3N2

3.95x102

A/Human/Hubei/3/2005_H3N2

2.93x104

A/Bar-headed Goose/QH/BTY2/2015_H5N1

1.98x105

A/Anhui/1/2013_H7N9

7.90x105

The Flu B minimum detection limit for the EZERTM Flu&COVID-19 Antigen Combo Rapid Test was established based on a total of 2 influenza B.

Influenza Viral Strain

Calculated LoD
(TCID50/mL)

B/Victoria

4.25x103

B/Yamagata

1.58x102

Accuracy

 

Influenza A

Influenza B

COVID-19

Relative Sensitivity

86.8%

91.7%

96.6%

Relative Specificity

94.0%

97.5%

100%

Accuracy

92.2%

96.1%

98.9%

Time to results

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

Kit storage conditions

2~30°C

Contents

Description

Qty

Test devices

20

Sterilized swabs

20

Extraction tubes

20

Nozzles

20

Tube stand

1

Package insert

1

Ordering Information

Product Cat.No. Contents
EZERTM Flu&COVID-19 Antigen Combo P213110 20 Tests

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