COVID-19 Neutralizing Antibody Rapid Test Device（Colloidal Gold）
Manufactured by HANGZHOU LYSUN BIOTECHNOLOGY Co. Ltd., China - http://www.lysunbio.com/
Device identification number
2142
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
Antibody
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha)
Commercial Status
In development
Last Update
2022-08-24 09:08:01 CET
Comments
None
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
Yes
Subcategory
Sample collection device
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Capture
Detection Principle
Colloidal gold
LOD
0 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % (0 of 413）
False negatives
0.42 % ((1 of 239）)
Precision
Evaluated
Accuracy
99.85 % ((95%CI: 99.15%~100%))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
99.58 % ((95%CI: 97.69%~99.99%))
Clinical Specificity
100 % ((95%CI: 99.28%~100%))
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