SG Diagnostics COVID-19 Saliva Rapid Test Kit
Manufactured by SG Diagnostics Pte Ltd., Singapore - www.sgdiagnostics.com
Device identification number
2563
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cartridge, Lateral flow
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
Comments
Detected antigens are Spike protein and Nucleocapsid protein
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Membrane-based
LOD
50 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
see Clinical Performance Data
False negatives
see Clinical Performance Data
Precision
Evaluated
Accuracy
95.18 % ( (Antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.75 % ( (Antigen))
Clinical Specificity
96.37 % ( (Antigen))
Type of antigen
Spike 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