The Food and Drug Administration warned patients and healthcare providers this week about the potential risks of false negative results, specifically with Curative’s COVID-19 test. While no specific problems with the San Dimas-based company’s test were identified, the FDA did say the test must be performed in accordance with its labeling to ensure correct results. The test should only be used in symptomatic people within 14 days of symptoms developing, according to the FDA. Additionally, the FDA asks that people taking the self-administered test, be observed by a health care worker during sample collection. False negatives can result in infected people unknowingly spreading the coronavirus and further delaying treatment, health officials warn. The city of Los Angeles as well as the county and Riverside County have contracts with Curative to perform testing at various sites. Those who set up an appointment arrive and self-administer the test by swabbing inside their mouths. “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,” the FDA wrote in a safety alert Monday, Jan. 4. The FDA is recommending medical providers use a different test if they suspect a patient’s results from the Curative test may be false. Individuals who were tested more than two weeks ago don’t need to be retested unless they show symptoms or suspect they contracted the virus. “A negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions,” the agency said. “A negative result does not exclude the possibility of COVID-19.” Curative representatives could not immediately be reached for comment.

Source:
https://www.pe.com/2021/01/07/fda-warns-of-false-results-from-san-dimas-based-curative-coronavirus-tests/

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