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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 Rapid Antigen Test

Manufactured by Biopanda Reagents, United Kingdom - www.biopanda.co.uk 

Device identification number
2034
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Anterior nasal swab, Nasal swab
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Test has been validated by the UK Department of Health and has passed the full validation process.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
100 RNA-copies (RNA copies/ml)
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.3 %
False negatives
5.9 %
Precision
Evaluated
Accuracy
97.7 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
92.2 %
Clinical Specificity
99.6 %
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