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
2450
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
IgG, IgM
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
The LOD has been referred to the minimum sample volume needed to perform the test. The referral test ID is 1889
Assay Type
Immuno-Antibody
Reader Required
No
Subcategory
Other ()
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Detection Principle
Colloidal gold
LOD
20 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
4.4 %
False negatives
8.93 %
Precision
Evaluated
Accuracy
92.75 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
91.07 %
Clinical Specificity
95.37 %
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