COVID-19 caused by SARS-CoV-2 coronavirus remains an important topic worldwide, and the need for testing is urgent and ongoing. Labs need a rapid and high-frequency approach to detection that seamlessly integrates into existing automated workflows.
The artus SARS-CoV-2 Prep&Amp UM Kit is a liquid-based approach to viral RNA detection. The kit is optimized for a simple sample preparation followed by qualitative real-time PCR detection of SARS-CoV-2 RNA.
Symptomatic | Asymptomatic | |
---|---|---|
nasopharyngeal swabs (NPS) |
✔ |
✔ |
nasal swabs |
✔ |
✔ |
oropharyngeal swabs |
✔ |
✔ |
neat saliva specimens |
✔ |
|
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The artus SARS-CoV-2 Prep&Amp UM Kit is for in vitro diagnostic use.
Validation of this test has not been reviewed by FDA. Review under the EUA program is pending. Distributed in accordance with the guidance on Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency, Section IV.C.2. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests or by similarly qualified non-U.S. laboratories.