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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



SARS-CoV-2 & Influenza A/B Ag Combo FIA

Manufactured by ACON Biotech (Hangzhou) Co., Ltd., China - https://www.aconbio.com/ 

Device identification number
2595
CE Marking
Yes
HSC common list (RAT)
×No
Format
Lab-based, Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal 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.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3 B.1.621 (Mu), P.1 (Gamma), P.2 (Zeta), P.3 (Theta), C.37 (Lambda), B.1.616
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Assay Type
Immuno-Antigen
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Fluorescence
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0.19 % (1/502 (COVID))
Fp
0 % 0/592 (Influ.B)
Fp
0.76 % (4/592 (Influ.A))
Fn
2 % (3/150 (COVID))
Fn
1.66 % (1/60 (Influ.A))
Fn
3.33 % (2/60 (Influ.B);)
Precision
Evaluated
Accuracy
99.4 % ( (SARS-CoV-2))
Accuracy
99.2 % ((Influ.A))
Accuracy
99.7 % ((Influ.B))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.7 % ( (Influ.B))
Clinical Sensitivity
98.3 % ( (Influ.A))
Clinical Sensitivity
98 % ( (SARS-CoV-2))
Clinical Specificity
99.3 % ((Influ.A))
Clinical Specificity
100 % ((Influ.B))
Clinical Specificity
99.8 % ( (SARS-CoV-2))
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