Epithod®616 IgG Test Kit
Manufactured by DxGen Corp., South Korea - www.dxgenco.com
Device identification number
1720
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Manual
Physical Support
Cassette
Target
Antibody, IgG
Specimen
Serum, Whole blood
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Measurement
Quantitative
Time
3 minutes
LOD
10000 AU
Calibration
evaluated
Crossreactivity
evaluated
Fp
24 (Positive percent agreement (PPA) was determined by testing 97 positive samples with a clinical diagnosis of COVID-19 based on a positive PCR method. Overall, 88% of the positive samples yielded an IgG positive result with 0-7 days (35/46, 76%), 8-14 days)
Fn
5 (Negative percent agreement (NPA) was determined by testing 100 negative samples, including 2 negative conversion samples from recovered patients. Overall, 95% of the negative samples yielded an IgG negative result. )
Precision
not evaluated
Accuracy
88 % IgG
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
88 % IgG
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