Skip to main content
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 Rapid Test

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

Device identification number
2594
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
Comments
N/A
Assay Type
Immuno-Antigen
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
160 TCID50/ml (for SARS-CoV-2)
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0.29 % (NP swab:1/335(Influ.B))
Fp
% Nasal swab:1/430(COVID)
Fp
0.59 % (NP swab: 2/335(Influ.A))
Fp
0.38 % (NP swab:1/257(COVID))
Fp
0.19 % (Nasal swab: 1/505((Influ.B))
Fp
0.39 % (Nasal swab 2/505(Influ.A))
Fn
2.66 % (Nasal swab :4/150 (COVID))
Fn
1.66 % (NP swab:1/60(Influ.B))
Fn
1.66 % (NP swab:1/60(Influ.A))
Fn
2.17 % (NP swab:3/138(COVID))
Fn
4 % (Nasal swab 3/75((Influ.B))
Fn
2.66 % (Nasa swab 2/75(Influ.A))
Precision
Evaluated
Accuracy
99.14 % (Nasal swab:(SARS-CoV-2))
Accuracy
99.31 % (Nasal swab (Influ.A))
Accuracy
99.31 % (Nasal swab (Influ.B))
Accuracy
98.99 % (NP swab:(SARS-CoV-2))
Accuracy
99.24 % (NP swab: (Influ.A))
Accuracy
99.49 % (NP swab:(Influ.B))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.33 % (NP swab:(Influ.B))
Clinical Sensitivity
98.33 % (NP swab:(Influ.A))
Clinical Sensitivity
97.83 % (NP swab:(SARS-CoV-2))
Clinical Sensitivity
96 % (Nasal swab: (Influ.B))
Clinical Sensitivity
97.33 % (Nasal swab: (Influ.A))
Clinical Sensitivity
97.33 % (Nasal swab:(SARS-CoV-2))
Clinical Specificity
99.77 % (Nasal swab:(SARS-CoV-2))
Clinical Specificity
99.6 % (Nasal swab: (Influ.A))
Clinical Specificity
99.8 % (Nasal swab: (Influ.B))
Clinical Specificity
99.61 % (NP swab:(SARS-CoV-2))
Clinical Specificity
99.4 % (NP swab:(Influ.A))
Clinical Specificity
99.7 % (NP swab:(Influ.B))
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