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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

RapiCov Rapid Antigen Test Kit for COVID‐19

Manufactured by Genes2me Private LTD, India

Device identification number
4072
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
Other (N- Gene (Nucliotide protein))
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus, SARS-CoV, SARS-CoV-2
Pathogens detected
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Influenza A H1N1, Influenza A H3N2, Influenza B, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus, SARS-CoV, SARS-CoV-2
Type of Antigen (in case of Antigen-based)
Other
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.429 (Epsilon), B.1.525 (Eta), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, Other (B.1.618), P.1 (Gamma), P.2 (Zeta)
Commercial Status
Commercialised
Last Update
2022-09-20 02:45:47 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Subcategory
N.A.
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Subclass
N.A.
Detection Principle
Other (Antibody-Antigen interaction)
LOD
0.4 ng/mL
Calibration
Evaluated
Analytical Sensitivity
98.33 %
Analytical Specificity
98.6 %
Analysis of cross reactivity
Evaluated
False positives
24 ng/mL
False negatives
24 ng/mL
Precision
Evaluated
Accuracy
100 %
Robustness
Evaluated
Clinical Sensitivity
98.33 %
Clinical Specificity
98.6 %

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