The SDI SARS-CoV-2 assay is a real-time reverse transcription polymerase chain reaction (Viral RT-PCR) test for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider. Testing using this assay is limited to SDI Laboratories, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. The SDI SARS-CoV-2 assay is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The SDI SARS-CoV-2 assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.
SDI Labs’ COVID-19 Viral RT-PCR RNA test has not been FDA cleared or approved. It has been authorized by FDA under an Emergency Use Authorization (EUA), and has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The test is eligible for authorization under the March 31, 2020 EUA for Molecular-based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 (Molecular LDT COVID-19 Authorized Test). The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.