COVID-19 Antigen Rapid Test Kit (Salivia)
Manufactured by Safecare Biotech (Hangzhou) Co. Ltd., China - https://www.safecare.com.cn
Device identification number
2288
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Saliva
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, 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.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Method
Immunoassay
Time
10 minutes
LOD
0 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.75 % ((1 false positive from 132 tests))
False negatives
1.08 % ((2 false negative from 184 tests))
Precision
Evaluated
Accuracy
99 % ( (Antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98 % ( (Antigen))
Clinical Specificity
99 % ( (Antigen))
Type of antigen
Nucleoprotein
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