Novel Coronavirus (2019-nCoV) IgG / IgM Antibody Testing Kit (Colloidal Gold)
Manufactured by Nanjing Norman Biological Technology Co. Ltd., China - https://www.normanbio.com
Device identification number
2515
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
Comments
/
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colloidal gold
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % IgG (whole blood)
False positives
0 % IgM (whole blood)
False negatives
14.13 % IgG ((whole blood))
False negatives
4.35 % IgM ((whole blood))
Precision
Evaluated
Accuracy
95.55 % IgG
Accuracy
98.63 % IgM
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
85.87 % IgG
Clinical Sensitivity
95.65 % IgM
Clinical Specificity
100 % IgG
Clinical Specificity
100 % IgM
Type of antigen
Other
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