Novel Coronavirus (SARS-CoV-2) Neutralizing Antibody Detection Kit (Competitive ELISA)
Manufactured by Beijing Bohui Innovative Biotechnology Co. Ltd., China - http://www.bohui-tech.com/
Device identification number
2045
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/515/2021.
Assay Type
Immuno-Antibody
Method
ELISA
Time
120 minutes
Subclass
Neutralization Antibody (NAb)
LOD
20 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2.4 % (Serum：5/208;)
False positives
0.98 % (Plama:2/203)
False positives
1.94 % (Whole blood:4/206)
False negatives
0.49 % (Whole blood:2/411)
False negatives
0.72 % (Plama:3/414)
False negatives
0.24 % (Serum：1/409;)
Precision
Evaluated
Accuracy
98 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99.51 (Serum:(95%CI：97.28%~99.91%) )
Clinical Sensitivity
98.53 (Plasma:95%CI：95.77%~99.50%))
Clinical Sensitivity
99.02 (Whole blood:(95%CI：96.50%~99.73%))
Clinical Specificity
99.03 (Whole blood:(95%CI：97.54%~99.62%))
Clinical Specificity
99.52 (Plasma:(95%CI：98.25%~99.87%))
Clinical Specificity
98.79 (Serum: (95%CI：97.20%~99.48%))
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