FDA issued a safety communication to alert patients and healthcare providers of the risk of false covid-19 results, particularly false negative covid-19 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.
For more information, read the FDA safety communication.