Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19

Risk of false results, particularly false negative results, with the Curative SARS-Cov-2 test.

If your email program has trouble displaying this email, view as a webpage. Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19 - FDA Safety Communication Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to alert 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 Other unintended adverse events. This safety communication provides: Important information regarding the use of the Curative SARS-Cov-2 Test. Recommendations for health care providers whose patients may have been tested with the Curative SARS-Cov-2 Test. Recommendations for people who may have been tested with the Curative SARS-Cov-2 Test. Background on the issue and the FDA's actions to address the issue. Instructions for reporting problems with the Curative SARS-Cov-2 Test to the FDA. Read the Communication Questions? If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE).

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