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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Humasis COVID-19 IgG/IgM Test

Manufactured by Humasis Co. Ltd., South Korea - http://www.humasis.com/en/ 

Device identification number
219
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette, Lateral flow
Target type
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
NA
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Visualisation system
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Capture
LOD
0 %
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
4 % IgM
False positives
8 % IgG
False negatives
1.3 % IgM
False negatives
0 % IgG
Precision
Evaluated
Accuracy
99
Reproducibility
Evaluated
Robustness
Not 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