SARS-CoV-2 Antigen Test Kit（Lateral Flow Assay）
Manufactured by Wuxi Biohermes Bio & Medical Technology Co. Ltd., China - www.biohermes.com
Device identification number
2143
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Card, Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Hemophilus Influenzae, Influenza A, Influenza B, Mycobacterium Tuberculosis, Respiratory Syncytial V (RSV)
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
BioHermes SARS-CoV-2 Antigen Test is a lateral flow immunoassay intended for the qualitative detection of antigen to SARS-CoV-2 in naso-/oropharyngeal swab. The test is to be used as an aid in the diagnosis of Coronavirus infection disease (COVID-19).
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
2.5 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
4.69 %
False negatives
1.98 %
Precision
Evaluated
Accuracy
97.11 % ((Antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.31 % ((Antigen))
Clinical Specificity
98.02 % ((Antigen))
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