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

COVID-19 In Vitro Diagnostic Medical Device - detail



COVID-19 Antigen Rapid Test

Manufactured by PRIMA Lab, Switzerland - primahometest.com/en/ 

Device identification number
1797
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Specimen
Nasal swab, Other
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
100 IU/ml
Fp
0
Fn
0
Accuracy
98 %
Clinical Sensitivity
96.4 %
Notes
The test can be used both with nasopharyngeal and nasal swab. Functionality confirmed with the most known SARS-CoV-2 Variants including English, Brazilian and South African.

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