SARS-CoV-2 Antigen Test Kit (GICA)-Saliva
Manufactured by Shenzhen Kisshealth Biotechnology Co. Ltd., China - http://en.kisshealth.cn/
Device identification number
2659
CE Marking
×No
HSC common list (RAT)
×No
Format
Manual
Physical Support
Lateral flow
Target type
Antigen
Specimen
Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
AT.1, 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.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
N.A.
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Visualisation system
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
3.54 %
False negatives
0.83 %
Precision
Evaluated
Accuracy
98.16 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.45 %
Clinical Specificity
96.45 %
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