SG Diagnostics Immunity Rapid Test Kit (anti-Spike RBD IgG Antibody)
Manufactured by SG Diagnostics, Singapore - www.sgdiagnostics.com
Device identification number
2540
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, 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
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
Detects anti-Spike RBD IgG antibodies
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