SARS-CoV-2 Rapid Antigen Test Cassette
Manufactured by SureScreen Diagnostics, United Kingdom - www.surescreen.com
Device identification number
2297
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual, Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Anterior nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, P.2 (Zeta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Validated via UK Porton Down PHE process: https://www.gov.uk/government/news/british-manufacturer-surescreen-diagnostics-to-supply-20-million-rapid-lateral-flow https://www.gov.uk/government/publications/sars-cov-2-lateral-flow-antigen-tests-evaluation-of-voc1-and-voc2/sars-cov-2-lateral-flow-antigen-tests-evaluation-of-voc1-kent-uk-and-voc2-south-africa https://www.gov.uk/government/publications/assessment-and-procurement-of-coronavirus-covid-19-tests/outcome-of-the-evaluation-of-rapid-diagnostic-assays-for-specific-sars-cov-2-antigens-lateral-flow-devices
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
LOD
90 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1 %
False negatives
3.9 %
Precision
Evaluated
Accuracy
98.3 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.1 %
Clinical Specificity
99 %
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