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 (RAT)
×No
Format
Automated
Target type
Antibody
Specimen
Plasma, Serum
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-10-20 09:26:48 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
Analysis of cross reactivity
Evaluated
False positives
A total of 1930 samples were collected from different populations before the outbreak of COVID-19, w
False negatives
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