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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).

As with any test procedure, good laboratory practice is essential to the proper performance of this assay. Due to the high sensitivity of this test, care should be taken to keep reagents and amplification mixtures free of contamination. The Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test workflow should be performed by qualified and trained staff to avoid the risk of erroneous results.

For in vitro diagnostic use only.

For prescription use only.

For Emergency Use Authorization (EUA) Only.

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 authorized 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.

This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.

This test 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 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Specimens should always be treated as if infectious and/or biohazardous in accordance with safe laboratory procedures. Refer to Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with SARS-CoV-2.

Follow necessary precautions when handling specimens. Use personal protective equipment (PPE) consistent with current guidelines for the handling of potentially infectious samples. Refer to Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition – CDC.

Do not eat, drink, smoke, apply cosmetics or handle contact lenses in areas where reagents and human specimens are handled.

Modifications to assay reagents, assay protocol or instrumentation are in violation of the product Emergency Use Authorization.

Do not use the kit after the indicated expiry date.

Dispose of waste in compliance with local, state, and federal regulations.

Safety Data Sheets (SDS) are available upon request.

Positive results are indicative of the presence of SARS-CoV-2 RNA.

Handle all samples and controls as if they are capable of transmitting infectious agents.