COVID-19 Antigen Rapid Test
Manufactured by PRIMA Lab SA, 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
Commercial Status
Commercialised
Last Update
2022-11-03 08:55:05 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
100 IU/ml
False positives
0
False negatives
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