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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
×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 06:50:54 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