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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

2019-nCoV Neutralizing Antibody Test Kit (colloidal gold method)

Manufactured by Guangdong Hecin Scientific Inc., China - https://www.hecin-scientific.cn/ 

Device identification number
1811
CE Marking
Yes
HSC common list (RAT)
×No
Format
Lab-based
Physical Support
Cassette
Target type
Antibody
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
LOD
1 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
16 AU (16)
False negatives
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