Anti-SARS-CoV-2 RBD CLIA Microparticles
Manufactured by AUTOBIO DIAGNOSTICS. Ltd., China - https://www.autobio.com.cn/
Device identification number
2429
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
2022-08-24 09:08:01 CET
Comments
The unit of LOD is AU/mL.
Assay Type
Immuno-Antibody
Subcategory
Other ()
Method
CLIA
Measurement
Quantitative
Time
17 minutes
Subclass
Sandwich
LOD
3 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.22 % ( from 1334 samples before the outbreak of COVID-19)
False negatives
3.72 % ( from 215 samples after inoculation from 15 to 75 days)
Precision
Evaluated
Accuracy
99.29 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
79.49 %
Clinical Specificity
99.78 %
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