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

COVID-19 In Vitro Diagnostic Medical Device - detail



SCREEN TEST COVID-19 AG - COVID-19 ANTIGEN RAPID TEST

Manufactured by SCREEN ITALIA S.r.l., Italy - www.screenitalia.it 

Device identification number
1681
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab, Other
Commercial Status
Commercialised
Last Update
2022-03-14 09:42:40 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
50 AU
Calibration
not evaluated
Crossreactivity
evaluated
Fp
1.23 % (1 on 81)
Fn
2.44 % (3 on 123)
Precision
evaluated
Accuracy
98 % ((95%CI: 95.1%-99.5%))
Reproducibility
not evaluated
Robustness
not evaluated
Clinical Sensitivity
96.4 % ((95%CI: 89.8%- 99.2%))
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