warning that, given the low prevalence of the virus in the general population, even the most accurate tests could be wrong half of the time.“Serologic test results should not be used to make decisions about grouping persons residing in or being admitted to congregate settings, such as schools, dormitories, or correctional facilities,” the guidelines state. “Serologic test results should not be used to make decisions about returning persons to the workplace.
“The best possible scenario is that people get infected and they have protective immunity for a long time,” she said. “That would be awesome. But we just don’t have [evidence of] that right now.” Anders Boman, the son of the medical director and co-founder of Because Health, said that until the COVID-19 crisis occurred, the company that launched in Seattle last year was focused on “a niche of integrative care and sexual health,” including hormone treatments for men and women.
The FDA normally follows a stringent approval process for tests to detect diseases, often a costly effort that can take months or years. That typically requires independent validation of the accuracy of the tests. But after being criticized for the fumbled rollout of diagnostic tests during the start of the current pandemic, the FDA swung hard in the other direction, waiving its usual requirements and letting firms rush self-validated tests onto the market.
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