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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Novel Coronavirus (SARS-CoV-2) Neutralizing Antibodies Test (Quantum Dots Fluorescence Immunoassay)

Manufactured by Beijing Bohui Innovative Biotechnology Co. Ltd., China - http://www.bohui-tech.com/ 

Device identification number
2047
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Antibody
Specimen
Plasma, Serum, Whole blood
Lineages detected
B.1.525 (Eta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
We have CE marking, registered in Spanien. The products was registered in Spanish MOH with number RPS/294/2021.
Assay Type
Immuno-Antibody
Method
Immunochromatography
Time
15 minutes
Subclass
Neutralization Antibody (NAb)
Detection Principle
Fluorescence
LOD
20 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1.95 % (Serum:4/205)
False positives
1.47 % (Whole blood:3/204)
False positives
0.98 % (Plasma:2/204)
False negatives
0.73 % (Serum:3/412)
False negatives
0.48 % (Plasma:2/413)
False negatives
0.72 % (Whole blood:3/413)
Precision
Evaluated
Accuracy
97 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.53 % (Whole blood: (95% CI: 95.77%~99.50%))
Clinical Sensitivity
99.02 % (Plasma:(95% CI: 96.50%~99.73%) )
Clinical Sensitivity
98.53 % (Serum: (95% CI: 95.77%~99.50%) )
Clinical Specificity
99.52 % (Plasma: (95% CI: 98.25%~99.87%). )
Clinical Specificity
99.27 % (Whole blood: (95% CI:97.89%~99.75%))
Clinical Specificity
99.03 % (Serum: (95% CI:97.54%~99.62%) )
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