Novel Coronavirus Neutralizing Antibody Assay Reagent Kit
Manufactured by Hangzhou Realy Tech Co. Ltd., China - www.realytech.com
Device identification number
1802
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Card
Target type
Antibody
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
No
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
40 minutes
Subclass
Neutralization Antibody (NAb)
LOD
0 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.44 % (228 samples are proven negative of 229 negative specimens.)
False negatives
0 % 120 samples are proven negative of 120 positive specimens.
Precision
Evaluated
Accuracy
99.71 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99.9 %
Clinical Specificity
99.56 %
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