Rapid-VIDITEST anti- SARS-CoV-2 IgG/IgM
Manufactured by VIDIA spol. s r.o., Czechia - https://www.vidia.cz
Device identification number
2336
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
Antibody, IgG, IgM
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
Limit of detection: IgG 1:40, S- IgM 1: 100; N-IgM 1: 2500
Assay Type
Immuno-Antibody
Reader Required
No
Subcategory
Other ()
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Membrane-based
LOD
1 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1 AU
False negatives
5 AU
Precision
Evaluated
Accuracy
98.1 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.3 %
Clinical Specificity
98.6 %
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