CerTest SARS-CoV-2
Manufactured by CerTest Biotec, Spain - www.certest.es
Device identification number
1173
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Specimen
Nasal swab, Nasopharyngeal swab
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Commercial Status
Commercialised
Last Update
2022-09-05 04:45:10 CET
Comments
The buffer has SARS2 inactivation capability. The test detects equally the nucleo proteins from Alpha, Beta, Delta, Gamma and Omicrom variants.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Time
10 minutes
Clinical Sensitivity
93 % (Nasopharyngeal swab)
Clinical Specificity
99.8 % (Nasopharyngeal swab)
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