Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV- 2
Manufactured by Genesprint Group Limited
Device identification number
1609
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Detection Principle
Colloidal gold
LOD
170
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1.64 %
False negatives
1.52 %
Precision
Evaluated
Accuracy
87.06 % IgG
Accuracy
86.57 % IgM
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
87.06 % IgG
Clinical Sensitivity
86.57 % IgM
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