SARS-CoV-2 Rapid Antigen Test Nasal
Manufactured by Roche (SD BIOSENSOR), Switzerland - https://diagnostics.roche.com/
Device identification number
2228
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.617.1 (Kappa), B.1.621 (Mu), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The SARS-CoV-2 Rapid Antigen Test Nasal is technically identical to the nasopharyngeal test launched in 2020 (SARS-CoV-2 Rapid Antigen Test), which is already included in the EU common list of COVID-19 rapid antigen tests.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
146.6 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.91 % (5 false positives out of 546 PCR negative samples.)
False negatives
10.68 % (14 false negative results out of 131 PCR-positive samples for Ct ≤ 30)
Precision
Evaluated
Accuracy
95.5 % ( (95% CI: 93.7 % - 97.0 %))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
89.6 % ( (Ct ≤ 30) and 93.1 % (for Ct below LOD 27))
Clinical Specificity
99.1 %
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