SARS-CoV-2 Neutralizing Antibody Test Kit (MCLIA)
Manufactured by Wuhan EasyDiagnosis Biomedicine Co. Ltd., China - http://www.easydiagnosis.com.cn/
Device identification number
4002
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antibody
Antibody type
Monoclonal
Targets
spike protein
Specimen
Plasma, Serum
Cross-reactivity (pathogens tested)
Other (None)
Pathogens detected
SARS-CoV
Lineages detected
Other (None)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Self Test
No
Reader Required
Yes
Subcategory
Validity test kit
Method
CLIA
Measurement
Quantitative
Time
30 minutes
Subclass
Neutralization Antibody (NAb)
Detection Principle
Chemiluminescence
LOD
5 %
Analytical Sensitivity
97 %
Analytical Specificity
90 %
False positives
0.48 %
False negatives
2.41 %
Accuracy
98.97 %
Clinical Sensitivity
97.59 %
Clinical Specificity
99.52 %
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