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The FDA is alerting patients and health care providers of the risk of false results, particularly false negative results, with the Curative SARS-Cov-2 test. Risks to a patient of a false negative result include: delayed or lack of supportive treatment, lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community, or other unintended adverse events.

To reduce the risk of false negative results, it is important to perform the test in accordance with its authorization and as described in the authorized labeling, e.g., the Fact Sheet for Healthcare Providers. When the test is not performed in accordance with its authorization or as described in the authorized labeling, there is a greater risk that the results of the test may not be accurate.

BACKGROUND: The Curative SARS-Cov-2 Assay is a real-time RT-PCR test used to detect SARS-CoV-2, the virus that causes COVID-19. This test is authorized for prescription-only use. The test is performed by collecting a throat swab, nasopharyngeal swab, nasal swab, or oral fluid specimen from an individual suspected of COVID-19 by their health care provider.

RECOMMENDATIONS:

• Be aware of the important information regarding the use of the Curative SARS-Cov-2 test, which is described in the test’s authorized labeling, including the following:

  ◦ Collection of nasal swabs and oral fluid specimens is limited to symptomatic individuals within 14 days of COVID-19 symptom onset.

  ◦ Specimen collection must be directly observed and directed during the sample collection process by a trained health care worker at the specimen collection site.

  ◦ A negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions. A negative result does not exclude the possibility of COVID-19.

• Health care providers: Consider retesting your patients using a different test if you suspect an inaccurate result was given recently by the Curative SARS-Cov-2 test. If testing was performed more than two weeks ago, and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest.

• Patients and caregivers: Talk to your health care provider if you think you were tested with the Curative SARS-Cov-2 test (the test name is displayed on this test’s authorized Fact Sheets and, generally, the Fact Sheets must be provided with test result reports) and you have concerns about your test results.

• Report any problems you experience with the Curative SARS-Cov-2 test to the FDA, including suspected inaccurate results.

 Health professionals and patients are encouraged to report adverse events or suspected adverse events, including problems with test performance or results, related to the use of this product to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.

• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.