Diagnostic Kit for 2019-nCoV IgM/IgG Antibody (Colloidal Gold)
Manufactured by Shanghai BioGerm Medical Technology Co. Ltd., China - http://en.bio-germ.com/
Device identification number
2178
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV)
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Manual cassette colloidal gold
Assay Type
Immuno-Antibody
Method
Immunoassay
Time
10 minutes
Detection Principle
Colloidal gold
LOD
500 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
Require clinical data comparison
False negatives
Require clinical data comparison
Precision
Evaluated
Accuracy
98.36 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.18 %
Clinical Specificity
99.33 %
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