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

Angie SzumlinskiHealth

The U.S. Food and Drug Administration (FDA) issued a statement describing the risks of false results with the Curative SARS-Cov-2 test, particularly false negative results. Risks to a patient who has received a false negative can include delayed care as well as lack of monitoring of infected individuals, which can result in increased community spread of the virus. Recommendations from the FDA include:

  • 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
  • Consider retesting your patients using a different test if you suspect an inaccurate result was given recently by the Curative SARS-Cov-2 test
  • 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

Please read the full statement from the FDA for more information, including a description of the testing device, actions the FDA is taking, and links to report adverse events or problems with the tests.