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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 Rapid Test

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

Device identification number
2594
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Lab-based, Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Pathogens detected
Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, SARS-CoV
Commercial Status
Commercialised
Last Update
2021-09-01 06:38:28 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