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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 (Double Antigen Sandwich Colloidal Gold Immunochromatography)

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

Device identification number
2048
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/803/2021.
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
1.76 % (Serum: 6/340)
Fp
2.06 % (Whole blood:7/339)
Fp
1.19 % (Plasma: 4/337)
Fn
1.04 % (Serum: 5/477)
Fn
1.25 % (Plasma: 6/480)
Fn
1.46 % (Whole blood:7/478)
Precision
Evaluated
Accuracy
99 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.94 % (Whole blood:(95%CI:95.80%~99.00%))
Clinical Sensitivity
98.23 % (Plasma:(95%CI:96.19%~99.19%) )
Clinical Sensitivity
98.53 % (Serum: (95%CI:96.59%~99.37%) )
Clinical Specificity
99.16 % (Plasma:(95%CI:97.87%~99.67%). )
Clinical Specificity
98.54 % (Whole blood: (95%CI:97.01%~99.29%).)
Clinical Specificity
98.74 % (Serum: (95%CI:97.29%~99.42%) . )
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