Celltrion DiaTrust™ COVID-19 IgG/IgM Rapid Test
Manufactured by Humasis Co. Ltd., South Korea - http://www.humasis.com/en/
Device identification number
5719
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette, Lateral flow
Target type
Antibody, IgG, IgM
Antibody type
Monoclonal
Targets
Other (IgG, IgM)
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Anti-Nuclear Antibody, Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Cytomegalovirus (CMV), Hemophilus Influenzae, Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Influenza A, Influenza B, Mycoplasma Pneumoniae, Other (Dengue), Respiratory Syncytial V (RSV)
Pathogens detected
Other (None)
Type of Antigen (in case of Antigen-based)
Other
Lineages detected
Other (NA)
Commercial Status
Commercialised
Last Update
2022-10-18 08:52:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Visualisation system
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Capture
Detection Principle
Colloidal gold
LOD
0 %
Calibration
Evaluated
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
0 %
Precision
Evaluated
Accuracy
100 %
Robustness
Evaluated
Clinical Sensitivity
96 % (% IgM)
Clinical Sensitivity
92 % IgG
Clinical Specificity
98.7 % (% IgM)
Clinical Specificity
100 % IgG
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