COVID-VIRO
Manufactured by AAZ-LMB, France - https://www.covid19aaz.com/en/autotest-covid-viro-all-in/
Device identification number
1833
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
16 minutes
Subclass
Membrane-based
LOD
1.15 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
3.4 %
Precision
Evaluated
Accuracy
98.74
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
96.6 %
Clinical Specificity
100 %
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