SARS-CoV-2 Antibody Assay (CLIA)
Manufactured by Zybio Inc., China - https://www.zybio.com/en/
Device identification number
2213
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
Assay Type
Immuno-Antibody
Reader Required
Yes
Subcategory
Other ()
Method
CLIA
Measurement
Qualitative
Time
23 minutes
Subclass
Other ()
Detection Principle
Chemiluminescence
LOD
30000 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1.06 %
False negatives
1.43 %
Precision
Evaluated
Accuracy
96.12 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.41 %
Clinical Specificity
95.38 %
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