SG Diagnostics COVID-19 IgG/IgM Rapid Test Kit
Manufactured by SG Diagnostics, Singapore - www.sgdiagnostics.com
Device identification number
2543
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
IgG, IgM
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 IgG and IgM 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
95.09 % (IgM)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
91.54 % (IgM)
Clinical Specificity
97.02 % (IgM)
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