Chemtrue® COVID-19 (SARS-CoV-2) IgM/IgG Antibody Rapid Test Kit (Colloidal Gold)
Manufactured by Shanghai Chemtron Biotech Co., Ltd., China - http://www.chemtronbio.com/
Device identification number
2312
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-07-30 10:38:34 CET
Comments
product code:8038C
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colloidal gold
LOD
0 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0 % IgG Compared with RT-PCR in Clincal datas
Fp
0 % IgM Compared with RT-PCR in Clincal datas
Fn
5.2 % IgM (compared with RT-PCT in clincal datas)
Fn
6.9 % IgG (compared with RT-PCT in clincal datas)
Precision
Evaluated
Accuracy
96.83 % IgM ((Compared with RT-PCR in Clincal datas))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.81 % IgM (compared with RT-PCT in clincal datas)
Clinical Sensitivity
93.02 % IgG (compared with RT-PCT in clincal datas)
Clinical Specificity
100 % IgM (compared with RT-PCT in clincal datas)
Clinical Specificity
100 % IgG (compared with RT-PCT in clincal datas)
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