A real-time reverse-transcription polymerase chain reaction (real-time RT-PCR) assay, giving healthcare providers accurate and timely test results to ensure greater access to testing, promote earlier diagnosis and help limit the subsequent spread of infection. The test detects the presence of SARS-CoV-2 and is for use with patients who meet current guidance for evaluation of infection with COVID-19.
The test has been made available pursuant to the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for diagnostic testing in CLIA Certiﬁed high-complexity laboratories. The test is validated and performed at our national accredited lab partner to perform the test.
You can order the swabs for quick delivery to your office. NO CLIA WAIVER CERTIFICATE is required. You'll receive our tests complete with the transfer tube and the individual swab including prepaid return labels. You can read the Guidance letter from HHS regarding pharmacist’s ability to order and administer tests.
NOTE: Updated USFDA guidance issued on March 16, 2020, allows the distribution of this product for diagnostic use in laboratories or by healthcare workers at the point-of-care. The updated policy can be viewed by clicking here
Please check with your State Health Department for any specific regulation pertaining to COVID-19 testing by pharmacists