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

Device identification number
2046
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Manual
Target
Antibody
Specimen
Plasma, Serum, Whole blood
Lineages detected
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 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
120 minutes
Subclass
Neutralization Antibody (NAb)
LOD
20 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
1.47 % (Serum: 3/204;)
Fp
1.98 % (Whole blood:4/202)
Fp
1.47 % (Plasma: 3/203)
Fn
0.96 % (Plasma: 4/414)
Fn
1.44 % (Whole blood:6/415)
Fn
0.72 % (Serum: 3/413;)
Precision
Evaluated
Accuracy
97 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.06 % (Whole blood: (95% CI: 93.73%~98.65%))
Clinical Sensitivity
98.04 % (Plasma:(95% CI: 95.07%~99.23%) )
Clinical Sensitivity
98.53 % (Serum: (95% CI: 95.77%~99.50%) )
Clinical Specificity
99.27 % (Plasma: (95% CI: 97.89%~99.75%). )
Clinical Specificity
99.03 % (Whole blood: (95% CI: 97.54%~99.62%).)
Clinical Specificity
99.27 % (Serum: (95% CI: 97.89%~99.75%) )
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