SARS-CoV-2 IgG/IgM Rapid Test
Manufactured by BN Santé, France - www.biogyne.fr
Device identification number
2194
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody, IgG, IgM
Specimen
Whole blood
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
No additional information.
Assay Type
Immuno-Antibody
Method
Immunoassay
Time
15 minutes
LOD
10 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
16 AU
False negatives
4 AU
Precision
Evaluated
Accuracy
98 % ( (97,38 % à 98,92 %))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98 % ( (97,06 % à 99,67 %))
Clinical Specificity
98 % ( (96,83 % à 98.82 %))
Type of antigen
Other
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