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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2 NAb Q CLIA Microparticles

Manufactured by AUTOBIO DIAGNOSTICS., LTD., China - https://www.autobio.com.cn/ 

Device identification number
2232
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated
Target
Antibody
Specimen
Plasma, Serum
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-06-11 12:50:37 CET
Comments
The unit of LOD is AU/mL.
Assay Type
Immuno-Antibody
Method
CLIA
Measurement
Quantitative
Time
17 minutes
Subclass
Neutralization Antibody (NAb)
Detection Principle
Chemiluminescence
LOD
15.66 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
A total of 1930 samples were collected from different populations before the outbreak of COVID-19, w
Fn
4 % (The detection rate was 96% and the false negative rate was 4% in 150 samples from the recovery stage)
Precision
Evaluated
Accuracy
99.32 % (The accuracy of detection was 99.32% from 150 recovery and 1930 normal people)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
53.4 % ( (94/176))
Clinical Specificity
99.63 %
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