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

U.S. Food and Drug Administration sent this bulletin at 01/04/2021 02:05 PM EST

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US Food and Drug Administration

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).