Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Anti-SARS-CoV-2 Neutralizing Antibody ELISA Kit

Manufactured by Nanjing Vazyme Medical Technology Co. Ltd., China - www.vazyme.com 

Device identification number
1864
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Microplate
Target type
Antibody
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
http://www.vazymebiotech.com/COVID.html
Assay Type
Immuno-Antibody
Reader Required
Yes
Subcategory
Other ()
Method
ELISA
Measurement
Qualitative
Time
120 minutes
Subclass
Enzyme-linked
LOD
92.5 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
1 %
Precision
Evaluated
Accuracy
99.27 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.5 %
Clinical Specificity
99.3 %
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