The U.S. Food and Drug Administration (FDA) is alerting patients and healthcare 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.
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.