SARS-CoV-2 Neutralizing Antibody Kit (CLIA)
Manufactured by Maccura Biotechnology Co. Ltd., China - www.maccura.com/en
Device identification number
1953
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated
Physical Support
Cartridge
Target type
Antibody
Targets
membrane protein
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
For in vitro detection of neutralizing antibodies against SARS-CoV-2 in human serum or plasma.
Assay Type
Immuno-Antibody
Subcategory
Other ()
Method
Immunoassay
Time
20 minutes
Subclass
Neutralization Antibody (NAb)
LOD
2 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2.7 AU
False negatives
2.2 AU
Precision
Evaluated
Accuracy
97.8 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.3 %
Clinical Specificity
98.2 %
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