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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 & Influenza A/B Antigen Nasal Test Kit

Manufactured by Assure Tech (Hangzhou) Co. Ltd., China - www.diareagent.com 

Device identification number
3106
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Human Metapneumovirus (HMPV), MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, Rhinovirus A, Rhinovirus B, SARS-CoV
Pathogens detected
Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, Influenza B Victoria, Influenza B Yamagata, SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The COVID-19&Influenza A/B Antigen Nasal Test Kit is an in vitro immunoassay. The assay is for the direct and qualitative detection of viral nucleocapsid proteins of SARS-CoV-2, Influenza A virus, and Influenza B virus from nasal secretions. The test is for self-testing use. Children aged between 2 and 18 years old, must be supervised or aided by an adult when carrying out the test. Negative results do not preclude these viral infections. Testing results should not be the sole basis for treatment or other management decisions. This test is intended for asymptomatic and people who with symptoms of COVID-19 within the first 7 days of symptom onset.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
251.2 TCID50/ml (1×10^2.4 TCID 50/mL (for SARS-CoV-2))
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.5 % (2/377 - Flu A)
False positives
0.3 % (1/310 - COVID-19)
False positives
0.3 % (1/396 - Flu B)
False negatives
3.6 % (5/140 - COVID-19)
False negatives
4.1 % (3/73 - Flu A)
False negatives
5.6 % (3/54 - Flu B)
Precision
Evaluated
Accuracy
98.7 % (444/450 COVID-19)
Accuracy
98.9 % (445/450 - Flu A)
Accuracy
99.1 % (446/450 - Flu B)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.4 % (51/54 - Flu B)
Clinical Sensitivity
95.9 % (70/73 - Flu A )
Clinical Sensitivity
96.4 % (135/140 - COVID-19)
Clinical Specificity
99.7 % (395/396 - Flu B)
Clinical Specificity
99.7 % (309/310 - COVID-19)
Clinical Specificity
99.5 % (375/377 - Flu A)
Type of antigen
Nucleocapsid protein

The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements