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Flu&COVID-19 Duo Rapid Test Kit Swab Antigen CE Test Kit Real Reliable Factory

CE Certification

KaiBiLiTM Flu & COVID-19 Antigen Duo 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 nasopharyngeal (NP) specimens. The detection is based on the antibodies which were developed specifically recognizing and reacting with the nucleoprotein of virus.


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Introduction

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.

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.1

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.

KaiBiLiTM Flu & COVID-19 Antigen Duo 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 nasopharyngeal (NP) specimens. The detection is based on the antibodies which were developed specifically recognizing and reacting with the nucleoprotein of virus.

Detection

KaiBiLiTM 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 direct nasopharyngeal (NP) specimens.

Specimen

Nasopharyngeal

Limit of Detection (LoD)

SARS-CoV-2 & Flu: 140 TCID50/mL

Influenza A

Influenza Viral Strain

Calculated LOD (TCID50/mL)

A/New Caledonia/20/1999_H1N1

8.50×103

A/California/04/2009_H1N1

2.11×103

A/PR/8/34_H1N1

2.93×103

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

4.94×102

A/Guizhou/54/89_H3N2

3.95×102

A/Human/Hubei/3/2005_H3N2

2.93×104

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

1.98×105

A/Anhui/1/2013_H7N9

7.90×105

Influenza B.

Influenza Viral Strain

Calculated LOD (TCID50/mL)

B/Victoria

4.25×103

B/Yamagata

1.58×102

Accuracy

Influenza A Influenza B COVID-19
Relative Sensitivity 86.80% 91.70% 96.60%
Relative Specificity 94% 97.50% 100%
Accuracy 92.20% 96.10% 98.90%

Time to Results

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

Kit storage conditions

2~30°C.

Contents

Test devices 20 tests
Sterilized swabs 20 pcs.
Extraction tubes (with 0.5mL extraction buffer) 20 pcs.
Nozzle with filter 20 pcs.
Tube Stand 1 pcs.
Package Insert 1 pcs.

Ordering Information

Product

Cat.No.

Contents

KaiBiLiTM Flu & COVID-19 Antigen Duo

P211137

20 Tests


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