SARS-CoV-2 IgM/IgG Antibody Test (Colloidal Gold)
Manufactured by Joinstar Biomedical Technology Co. Ltd., China - www.joinstar.cn
Device identification number
1204
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antibody, IgG, IgM
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
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Detection Principle
Colorimetry
LOD
0 AU
False positives
0 % No false positives in 112 samples vs PCR
False negatives
8.93 % (10 False negatives in 112 samples vs PCR)
Accuracy
91.07 % (IgG+IgM)
Clinical Sensitivity
89 % (90 samples which were PCR positive)
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