COVID-19 Antibody Rapid Test Kit (IgM)
Manufactured by Chongqing iSIA BIO-Technology Co. Ltd., China - www.isiabio.com.cn
Device identification number
1941
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
test results good
Assay Type
Immuno-Antibody
Method
Immunochromatography
Time
15 minutes
Detection Principle
Colloidal gold
LOD
0.8 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1 AU
False negatives
0 AU
Precision
Evaluated
Accuracy
97 % IgM
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97 % IgM
Clinical Specificity
97 % IgM
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