OPTI SARS-CoV-2 RT-PCR Test
Manufactured by OPTI Medical Systems, United States - www.optimedical.com
Device identification number
1406
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://www.optimedical.com/en/products-and-services/kits/opti-sars-cov-2-rt-pcr-test-kit/
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
50 minutes
LOD
5 copies/reaction
Positive control
SARS-CoV-2 (N1 target region) and the internal control (RNase P)
Negative control
PCR Grade Wate
Analytical Sensitivity
97 %
Analytical Specificity
100 %
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Notes
https://www.optimedical.com/files/art-06-57003-03-opti-sars-cov-2-rna-rt-pcr-test-ceivd-2.pdf;specimen: nasopharyngeal swabs, oropharyngeal swabs, bronchoalveolar lavage and sputum samples.
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