SARS-CoV-2 Neutralizing Antibody Assay (ELISA)
Manufactured by Zybio Inc., China - https://www.zybio.com/en/
Device identification number
2216
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
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
N/A
Assay Type
Immuno-Antibody
Reader Required
Yes
Subcategory
Other ()
Method
ELISA
Measurement
Quantitative
Time
90 minutes
Subclass
Enzyme-linked
LOD
0.08 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
3.37 %
False negatives
0.88 %
Precision
Evaluated
Accuracy
98.52 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.73 %
Clinical Specificity
99.13 %
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