Skip to main content
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 (Colloidal Gold)

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

Device identification number
2044
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
15 minutes
Subclass
Neutralization Antibody (NAb)
Detection Principle
Colloidal gold
LOD
20 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
3.41 % (serum:7/205)
Fp
1.94 % (whoreblood:5/257)
Fp
2.67 % (plasma:7/262)
Fn
1.45 % (serum:6/412)
Fn
1.81 % (plama:8/440)
Fn
2.47 % (whoreblood(11/445))
Precision
Evaluated
Accuracy
98 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.82 (whoreblood: (95%CI: 92.67%-97.65%))
Clinical Sensitivity
96.96 (plasma: (95%CI: 94.11%-98.45%))
Clinical Sensitivity
97.06 % (serum:(95%CI: 93.73-98.65%))
Clinical Specificity
98.41 (plasma:(95% CI: 96.75%~99.23%))
Clinical Specificity
98.86 (whoreblood: (95% CI: 97.36%~99.51%).)
Clinical Specificity
98.31 % (serum (95% CI:96.54%~99.18%))
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