§ 360bbb-3(b)(1), unless the declaration is terminated or the authorization is revoked sooner. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The Sports Drug Testing Laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity molecular-based clinical laboratory testing. Please complete our online forms to determine if you qualify for insurance/government billing.ĭisclaimer: This product has not been cleared or approved by the US Food and Drug Administration, but has been authorized by the US Food and Drug Administration under an EUA as a laboratory developed test for use by the Sports Drug Testing Laboratory. In most cases, insurance or government programs will cover 100% of the cost of your PCR saliva test. Otherwise, results are emailed to the patient by 8:30 pm the following day. Same-day test results are emailed to the patient by 8:30 pm on the day of their test. Same-day results are available to patients who test before 10:30 am. ![]() Please view this summary from the FDA on diagnostic testing. Premier’s diagnostic services and clinical areas include: OB/GYN Maternal-Fetal Medicine General Imaging Vascular Imaging Cardiac Ultrasounds Premier maintains strong relationships and volume purchasing with some of the largest and most technologically advanced imaging companies in the world. PCR tests are 98.9% accurate and have EUA approval from the FDA. This process amplifies the possibly infected DNA to allow detection of the COVID-19 virus. ![]() There, the samples undergo a DNA amplification process called Polymerase chain reaction, or PCR. The saliva samples are then collected and transported to a processing lab located in South Jordan, Utah. To take this test, patients excrete saliva into a sterile test tube provided to them at the testing site. Premier Diagnostics uses a saliva-based RT-PCR test to detect the COVID-19 virus.
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