COVID-19 IgM Antibody Test Kit (Colloidal Gold)
Manufactured by Bioneovan Co. Ltd., China - www.bioneovan.com
Device identification number
2208
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based, Near POC / POC
Physical Support
Card, Cassette
Target type
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
LOD
1.1 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.9 % IgM
False negatives
13.8 % IgM
Precision
Not evaluated
Accuracy
94.5 % IgM ( (88%CI:92.8%-95.9%))
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
86.2 % IgM ((88%CI:81.8%-89.7%))
Clinical Specificity
99.1 % IgM (（88% CI: 97.9%~99.9%）)
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