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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

AFIAS COVID-19 Ag

Manufactured by Boditech Med Inc, South Korea - https://www.boditech.co.kr/en 

Device identification number
1989
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Near POC / POC, Semi-automated
Physical Support
Cassette, Lateral flow
Target
Antigen
Specimen
Nasopharyngeal swab
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-07-22 01:15:14 CET
Comments
In the Link of Status validatie SARS-CoV-2 antigeen sneltesten, you can verify the clinical study, which shows that AFIAS Covid 19 Ag has a sensitivity of Ct <30: 96,4%.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Subcategory
Other
Method
Immunochromatography
Measurement
Semiquantitative
Time
12 minutes
Subclass
Sandwich
LOD
35.15 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
3 AU
Fn
11 AU
Precision
Evaluated
Accuracy
95.5 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
91.7 %
Clinical Specificity
98.7 %
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