2019-nCoV Neutralizing Antibody Test Kit (Fluorescent immunochromatography)
Manufactured by Guangdong Hecin Scientific, Inc. - https://www.hecin-scientific.cn/
Device identification number
1812
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Lab-based
Target
Antibody
Commercial Status
Commercialised
Last Update
03/16/2021 05:56
Assay Type
Immuno-Antibody
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
LOD
1 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
5
Fn
3
Precision
Evaluated
Accuracy
97.32 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.74 %
Clinical Specificity
97.58 %
Notes
fluorescence detection
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