GenSure COVID-19 Antigen Rapid Test Kit
Manufactured by GenSure Biotech Inc., China - www.gensbio.com/
Device identification number
2853
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Manual
Target type
Antigen
Specimen
Nasal swab, Saliva
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Respiratory Syncytial V (RSV), Rhinovirus
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, B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
50 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
There is a very small possibility of false positives.
False negatives
There is a very small possibility of false negatives.
Precision
Evaluated
Accuracy
98.68 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.73 %
Clinical Specificity
100 %
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