SARS-CoV-2 Ag Rapid Test
Manufactured by VIMEK BIOCONCEPT PVT Ltd., India - https://www.vimekbioconcept.in/
Device identification number
3000
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette, Strip
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Pathogens detected
SARS-CoV
Information on antigen epitope targeted by the antibodies used in the design of the device
The Covid-19 Antigen test strip is coated with goat anti mouse IgG antibodies at control region and anti- SARS CoV-2 antibodies at test region on the membrane and colloidal gold conjugated with antiSARS CoV-2 antibodies and mouse IgG
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The Covid-19 Antigen test strip is coated with goat anti mouse IgG antibodies at control region and anti- SARS CoV-2 antibodies at test region on the membrane and colloidal gold conjugated with antiSARS CoV-2 antibodies and mouse IgG
Assay Type
Immuno-Antigen
Self Test
No
Reader Required
N.A.
Subcategory
Visualisation system
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
250 (pg/mL)
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2 % (98 percent sensitivity)
False negatives
2 % (98 percent specificity)
Precision
Evaluated
Accuracy
98 % (Antigen)
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
98 % (Antigen)
Clinical Specificity
98 % (Antigen)
Type of antigen
Nucleocapsid protein
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