SARS-CoV-2 antigen Test Kit (LFIA)
Manufactured by Jiangsu Medomics medical technology Co.,Ltd., China - http://www.medomics-dx.com/
Device identification number
2006
CE Marking
✓Yes
HSC common list
✓Yes
HSC mutual recognition
✓Yes
Format
Near POC / POC
Physical Support
Card, Lateral flow
Target
Antigen
Specimen
Anterior nasal swab, Nasopharyngeal swab, Throat swab
Commercial Status
Commercialised
Last Update
2021-07-07 05:13:27 CET
Comments
Medomics SARS-CoV-2 antigen Test Kit(LFIA) is used to qualitatively detect SARS-CoV-2 in human samples in vitro. Medomics SARS-CoV-2 antigen Test Kit(LFIA) detects the SARS-CoV-2 nucleocapsid antigens with colloidal gold immunochromatography using a double antibody sandwich assay.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
LOD
10 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0.49 %
Fn
2.27 %
Precision
Evaluated
Accuracy
98.88 %
Reproducibility
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
97.73 %
Clinical Specificity
99.51 %
Type of antigen
Nucleoprotein
Notes
2 nucleocapsid antigens
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