SG Diagnostics COVID-19 Immunity Rapid Test Kit (anti-Spike RBD IgG Antibody)
Manufactured by SG Diagnostics Pte Ltd., Singapore - www.sgdiagnostics.com
Device identification number
2562
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cartridge, Lateral flow
Target type
IgG
Specimen
ACD plasma, Peripheral blood, Plasma, Venous whole blood, Whole blood, Whole blood with anti-coagulants
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Detects anti-Spike RBD IgG antibody
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Membrane-based
LOD
35 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
see Clinical Performance Data
False negatives
see Clinical Performance Data
Precision
Evaluated
Accuracy
97.2 % IgG
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.49 % IgG
Clinical Specificity
99 % IgG
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