Humasis COVID-19 Ag Home Test
Manufactured by Humasis Co. Ltd., South Korea - http://www.humasis.com/en/
Device identification number
2276
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
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
0 %
False negatives
5.6 %
Precision
Evaluated
Accuracy
97.4 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
95.3 %
Clinical Specificity
100 %
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