Innova SARS CoV-2 Antigen Rapid Qualitative Test
Manufactured by Innova Medical Group Inc., United States - www. innovamedgroup.com
Device identification number
1801
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Anterior nasal swab, Nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Point of Care version.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
20 minutes
Subclass
Membrane-based
Detection Principle
Colorimetry
LOD
1600 TCID50/ml
Analysis of cross reactivity
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.4 % ((22/5942))
False negatives
6 % ((5/84) @ viral loads > 10^6 RNA copies/mL)
Accuracy
99.6 %
Robustness
Not evaluated
Clinical Sensitivity
94 % (@ viral loads > 10^6 RNA copies/mL)
Clinical Specificity
99.6 %
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