Rapid-VIDITEST anti- SARS-CoV-2 (RBD) IgG
Manufactured by VIDIA spol. s r.o., Czechia - https://www.vidia.cz
Device identification number
2334
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
IgG
Specimen
Peripheral blood, Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Detection limit 1:640
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Other ()
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Neutralization Antibody (NAb)
LOD
0
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
3 %
False negatives
1 %
Precision
Evaluated
Accuracy
98 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.8 %
Clinical Specificity
98.7 %
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