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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Epithod®616 IgG Test Kit

Manufactured by DxGen Corp., South Korea - www.dxgenco.com 

Device identification number
1720
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Physical Support
Cassette
Target type
Antibody, IgG
Targets
nucleocapsid protein
Specimen
Serum, 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
Quantitative
Time
3 minutes
LOD
10000 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
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)
False negatives
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