SARS CoV 2 IgM/IgG Duo Test Kit (Colloidal Gold)
Manufactured by Wuhan HealthCare Biotechnology Co. Ltd., China - http://www.healthcare-biotech.com/
Device identification number
1889
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antibody, IgG, IgM
Targets
nucleocapsid protein
Specimen
Plasma, Serum, Whole blood, Whole blood with anti-coagulants
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
None
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Other ()
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Detection Principle
Colloidal gold
LOD
AU 0.00001
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
4.4 %
False negatives
8.93 %
Precision
Evaluated
Accuracy
92.75 % ((IgM/IgG))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
91.07 % ((IgM/IgG))
Clinical Specificity
95.37 % ((IgM/IgG))
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