SG Diagnostics COVID-19 Immunity Strength Rapid Test Kit (RBD Neutralizing Antibody)
Manufactured by SG Diagnostics, Singapore - www.sgdiagnostics.com
Device identification number
2028
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antibody, IgG
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
None
Assay Type
Immuno-Antibody
Reader Required
No
Subcategory
Other ()
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Membrane-based
LOD
0 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2 AU
False negatives
4 AU
Precision
Evaluated
Accuracy
97.07 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.19 %
Clinical Specificity
98 %
Type of antigen
Other
Notes
Neutralizing antibody
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