Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2
Manufactured by Novatech, Turkey - www.novadiag.com
Device identification number
1582
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
15 minutes
Detection Principle
Colorimetry
LOD
95 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
97 %
False negatives
98 %
Precision
Evaluated
Accuracy
98.6 % IgG
Accuracy
88.4 % IgM
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.4 % IgG
Clinical Sensitivity
71.4 % 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