High-throughput PCR testing system for SARS-CoV-2 detection under FDA EUA*

The Biosearch Technologies SAR-CoV-2 Real-Time and End-Point RT-PCR Test is a reverse transcriptase (RT)-polymerase chain reaction (PCR) test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 upper respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a that meet the requirements to perform high complexity tests.

Results are for the identification of SARS-CoV-2 RNA which is generally detected in respiratory specimens during the acute phase of infection. 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. The agent detected may not be the definite cause of disease. 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 the patient management decisions. Negative results must be combined with clinical observations, patient history and epidemiological information.

The Biosearch Technologies SARS-CoV-2 Real-Time RT-PCR Test is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time or endpoint PCR and in vitro diagnostic procedures. The Biosearch Technologies SARS-CoV-2 Real-Time and Endpoint RT-PCR Test is only for use under the Food and Drug Administration’s Emergency Use Authorization (EUA).

Validation of this test has not been reviewed by FDA. Review under the EUA program is pending.

The Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test has not been FDA cleared or approved; the test has been submitted for authorization by FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C. §263a, that meet requirements to perform high complexity tests.

The Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test has been submitted for authorization only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.

The Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test, if granted by the FDA, will be 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner