2019-nCoV IgM/IgG Antibody Test Kit (colloidal gold method)
Manufactured by Guangdong Hecin Scientific Inc., China - https://www.hecin-scientific.cn/
Device identification number
1807
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody, IgG, IgM
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
/
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colloidal gold
LOD
1 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2 AU
False negatives
3 AU
Precision
Evaluated
Accuracy
98.02 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.17 %
Clinical Specificity
98.63 %
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