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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

BHM COVID-19 Antigen Sealing Tube Test Strip

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

Device identification number
3007
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow, Strip
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab, Throat swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mumps Virus (MuV), Mycoplasma Pneumoniae, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Respiratory Syncytial V (RSV), Rhinovirus, SARS-CoV, Varicella Zoster Virus (VZV)
Pathogens detected
SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.617.2 (Delta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The BHM® COVID-19 Antigen Sealing Tube Test Strip is for the qualitative detection of SARS-associated coronavirus (SARS-CoV-2) antigens from the human nose to assist in the diagnosis of a coronavirus (Covid-19) infection. Since the strip detects the nucleocapsid protein antigen, the spike protein mutations have no effect on the function of the test. This unique design combines the test strip and diluent together in the same tube, which provides the concept: To combine sampling and testing into one. It also seals the sample swab and clinical sample in the tube to avoid potential biosecurity substances (such as the virus from the nasal or oral swab sample) spreading to the operator and the environment. The test is helpful to identify SARS-CoV-2 among symptomatic & asymptomatic people.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Validity test kit
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
612 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1 %
False negatives
1.5 %
Precision
Evaluated
Accuracy
98.8 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.5 %
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