Flu A/B + COVID-19 Antigen Combo Test Cassette Kit
Manufactured by Jiangsu Mole Bioscience Co. Ltd., China - http://en.molechina.com/
Device identification number
2340
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva, Sputum, Throat swab
Cross-reactivity (pathogens tested)
Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, SARS-CoV
Lineages detected
A.23.1, AT.1, 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.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, 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 test is intended for use in the simultaneous rapid in vitro detection and differentiation of influenza A virus, influenza B virus, and COVID-19 virus nucleocapsid protein antigen, but does not differentiate, between SARS-CoV and COVID-19 viruses and is not intended to detect influenza C antigens. Performance characteristics may vary against other emerging influenza viruses.
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
0.1 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % (FluA)
False positives
0 (FluB)
False positives
4.8 ((Covid-19 Antigen))
False negatives
1.9 %
Precision
Evaluated
Accuracy
99 % ((FluA&FluB))
Accuracy
98 % ((COVID-19))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 % ((FluA ))
Clinical Sensitivity
95.2 % ((COVID-19）)
Clinical Sensitivity
100 % ((FluB))
Clinical Specificity
99.4 ((FluA))
Clinical Specificity
99.4 ((FluB))
Clinical Specificity
98.1 (COVID-19)
Type of antigen
Nucleoprotein
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