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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

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
×No
HSC mutual recognition
×No
Format
Automated
Target
Antibody
Specimen
Plasma, Serum
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-07-14 02:32:22 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
Crossreactivity
Evaluated
Fp
0.22 % ( from 1334 samples before the outbreak of COVID-19)
Fn
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