SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma)
Manufactured by Hangzhou Biotest Biotech Co. Ltd., China - en.biotests.com.cn
Device identification number
1921
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antibody
Specimen
Plasma, Serum, Venous whole blood, Whole blood, Whole blood with anti-coagulants
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
A rapid test for the qualitative detection of neutralizing antibodies to SARS-CoV-2 in whole blood, serum, or plasma. Indirect method.
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Subclass
Neutralization Antibody (NAb)
LOD
0 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1.92 % (2 false positive results are observed in 104 negative samples)
False negatives
0 % No false negative result is observed in 152 positive samples
Precision
Evaluated
Accuracy
99 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 %
Clinical Specificity
98 %
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