SARS-CoV-2 Antigen
Manufactured by VIDIA spol. s r.o., Czechia - https://www.vidia.cz
Device identification number
2061
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Lineages detected
A.23.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.616
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
LOD = 100pg/ml or 1,16 x 10^2 TCID 50/ml
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Capture
LOD
100 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
2.42 %
False negatives
1 %
Precision
Evaluated
Accuracy
98 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96 %
Clinical Specificity
99 %
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