CoviSelf COVID-19 Antigen Lateral Flow Test Device OTC Home Test
Manufactured by Mylab Discovery Solutions Pvt. Ltd., India - https://mylabdiscoverysolutions.com/
Device identification number
2343
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Card, Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Anterior nasal swab, Mid-turbinates swab, Nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Coronaviruses (HCoV), Enterovirus A71 (EV-A71), Hemophilus Influenzae, Influenza A, Influenza A H1N1, Influenza B, MERS-CoV, Mycobacterium Tuberculosis, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Rhinovirus A, SARS-CoV
Lineages detected
A.23.1, AT.1, B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Capture
LOD
85 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.81 % (6/736)
False negatives
1.49 % (11/736)
Precision
Evaluated
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.18 ( (Antigen))
Clinical Specificity
98.9 ((Antigen))
Type of antigen
Nucleocapsid protein
Notes
Ares(2022)4013819
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