Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

BHM COVID-19 Antigen Rapid Test

Manufactured by Birmingham Biotech Ltd., United Kingdom - https://www.birminghambiotech.co.uk 

Device identification number
3008
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Coronaviruses (HCoV), Enterovirus A71 (EV-A71), Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, MERS-CoV, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Respiratory Syncytial V (RSV), Rhinovirus, Rhinovirus A
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The BHM® COVID-19 Antigen Rapid Test is intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in nasal and oral specimens during the acute phase of infection. Individuals who test negative and continue to experience COVID-19 like symptoms of fever, cough and/or shortness of breath may still have SARSCoV-2 infection and should seek follow up care with their general practitioner or healthcare provider.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Subcategory
Validity test kit
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
150 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
5.3 %
False negatives
1 %
Precision
Evaluated
Accuracy
97.4 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.7 %
Clinical Specificity
99 %
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