“Bottom line is that the current test works fine.”ĭespite concerns of accuracy, L.A. “It’s one of the most popular tests for a reason with over 10,000 sites across the country,” Klausner said in a phone interview Wednesday, Jan. While the warning reminds people to follow test instructions carefully and be observed, Klausner said, the FDA only authorizes the test, it does not regulate a physician’s or nurse’s practice. Jeffrey Klausner, Curative’s acting medical director, described the FDA notice about Curative’s test as “confusing” and did not provide any data to support its stance. Monahan also stressed that the FDA notice did “not raise any doubts about the accuracy of a positive test result,” and that the potential concern only relates to negative test results.ĭr. It is a problem for all coronavirus tests.” “This may happen more often when people are without symptoms of the coronavirus disease,” Monahan said in his memo. Test effectiveness praisedĬurative and its partners say the test is highly effective when administered according to label, as the FDA instructed in its public safety alert. On Jan.15, Curative launched its first company-run vaccination site at El Camino College in Torrance, and will soon open another test site in Palm Desert, a company spokesman said. While the alert ended the company’s partnerships with Los Angeles and Sonoma counties and Congress, Curative was undeterred, maintaining partnerships with 14 other states, cities and counties, and expanding its services to include COVID-19 vaccination. Additionally, the FDA asked that people taking the self-administered test be observed by a health-care worker. The test, which uses a technique known as polymerase chain reaction, or PCR, requires people to cough three times and use a cotton swab to rub along their gum line and tongue. 4 safety alert by the Food and Drug Administration pushed Curative into the national spotlight when it warned that the company’s test could produce false negative results if not properly administered.

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