SARS-CoV-2 IgM/IgG Rapid Test Kit (Colloidal Gold)
Manufactured by Triplex International Biosciences Co., Ltd, China - www.tibchina.com/index_en.aspx
Device identification number
1461
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Target
Antibody, IgG, IgM
Specimen
Serum, Whole blood
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
-1 AU
Calibration
evaluated
Crossreactivity
evaluated
Fp
0 AU
Fn
0 AU
Precision
evaluated
Accuracy
88.88 % IgG
Accuracy
93.88 % IgM
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
75.3 % IgG
Clinical Sensitivity
87.65 % IgM
Type of antigen
nucleoprotein
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