2019-nCoV Neutralizing Antibody Test Kit (colloidal gold method)
Manufactured by Guangdong Hecin Scientific, Inc. - https://www.hecin-scientific.cn/
Device identification number
1811
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Lab-based
Physical Support
Cassette
Target
Antibody
Commercial Status
Commercialised
Last Update
03/15/2021 09:14
Comments
/
Assay Type
Immuno-Antibody
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
LOD
1 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
16 AU 16
Fn
8 AU 8
Precision
Evaluated
Accuracy
91.97 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
91.3 %
Clinical Specificity
92.27 %
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