Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Instant-view® PLUS COVID-19 Antigen Test

Manufactured by Alfa Scientific Designs Inc, United States - www.alfascientific.com/ 

Device identification number
1678
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2021-05-10 01:18:20 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
3 minutes
LOD
2800 AU
Calibration
not evaluated
Crossreactivity
evaluated
Fp
3 out of 171
Fn
3 out of 40
Precision
not evaluated
Accuracy
97.2 %
Reproducibility
evaluated
Robustness
not evaluated
Clinical Sensitivity
92.5
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