2019-nCoV IgM/IgG Antibody Test Kit (colloidal gold method)
Manufactured by Bioteke Taizhou Biotechnology Co. Ltd., China - www.bioteke.cn/
Device identification number
1488
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Antibody, IgG, IgM
Targets
nucleocapsid protein
Specimen
Plasma, Serum
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
176 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1 for serum specimens, 2 for plasma specimens
False negatives
5 for serum specimens, 4 for plasma specimens
Precision
Evaluated
Accuracy
98.35 % (serum specimens)
Accuracy
98.3 % (plasma specimens)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.1 % (serum specimens)
Clinical Sensitivity
95.92 % (plasma specimens)
Type of antigen
nucleoprotein
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