SARS-CoV-2 Antigen
Manufactured by DIA.PRO Diagnostic Bioprobes Srl, Italy - www.diapro.it
Device identification number
2457
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Immunochromatographic Rapid Test for the qualitative detection of SARS-CoV-2 antigen in nasopharyngeal swab of individuals suspected of COVID-19 in acute phase or with symptoms typical of such disease
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Method
Immunochromatography
Time
15 minutes
Subclass
Membrane-based
LOD
800 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % None
False negatives
0 % None
Precision
Evaluated
Accuracy
100 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96 %
Clinical Specificity
98 %
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