SARS-CoV-2 Neutralizing Antibody Rapid Test (Colloidal Gold)
Manufactured by Joinstar Biomedical Technology Co. Ltd., China - www.joinstar.cn
Device identification number
1776
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Lateral flow
Target type
IgG
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Time
15 minutes
Detection Principle
Colorimetry
LOD
0 U/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % 0/39
False negatives
5.04 % (7/139)
Precision
Evaluated
Accuracy
98.5 %
Reproducibility
Evaluated
Clinical Sensitivity
94.7 %
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