FDA Warns About False Negatives from Curative Tests

The Food and Drug Administration issued a safety alert about the potential for false results from a rapid COVID-19 test made by Curative Inc. False negative results, in particular, have been a concern. To reduce the risk of false negatives, the FDA emphasized the importance of following the test’s guidelines. Swabs should be limited to patients who have COVID-19 symptoms and who test within 14 days of when their symptoms start, and trained healthcare workers should oversee the sample collection. Also, a negative result doesn’t rule out COVID-19 and shouldn’t be used as the sole basis for treatment or patient management, the FDA wrote. The FDA also encouraged healthcare providers and patients to report problems with the Curative test, including suspected inaccurate results.