SARS-CoV-2 Neutralizing Antibody Assay Kit (Immunochromatography)
Manufactured by Wuhan Life Origin Biotech Joint Stock Co., Ltd., China - www.szybio.com
Device identification number
1771
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Card, Lateral flow
Target
Antibody
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
0 U/ml
Crossreactivity
Evaluated
Fp
1.56 % ((2/128),95% CI(0.19%-5.53%))
Fn
5.36 % ((3/56),95% CI(1.12%-14.87%))
Precision
Evaluated
Robustness
Evaluated
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