Novel Coronavirus COVID-19 IgM/IgG Test Kit
Manufactured by Biocomma limited, China - www.biocomma.com
Device identification number
1686
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Target type
Antibody, IgG, IgM
Targets
nucleocapsid protein
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colloidal gold
LOD
312.5 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1.35 %
False negatives
0 %
Precision
Evaluated
Accuracy
99.26 % IgG
Accuracy
99.26 % IgM
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 % IgG
Clinical Sensitivity
100 % IgM
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