COVID-19 IgM/IgG Antibody Test Kit (Colloidal Gold)
Manufactured by Bioneovan Co. Ltd., China - www.bioneovan.com
Device identification number
2207
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Near POC / POC
Physical Support
Card, Cassette
Target type
IgG, IgM
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43)
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
No
Assay Type
Immuno-Antibody
Reader Required
No
Subcategory
Sample preparation
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Capture
Detection Principle
Colloidal gold
LOD
1.1 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
2.2 %
False negatives
5.1 %
Precision
Not evaluated
Accuracy
96.8 % ((93%CI:95.4%-97.8%))
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
94.9 % ((93%CI:91.8%-96.9%))
Clinical Specificity
97.8 % (（93% CI: 96.2%~98.7%）)
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