Among the more remarkable legacies of the COVID-19 pandemic is how quickly federal regulators, the health care industry and consumers moved to make at-home testing a reliable tool for managing a public health crisis.
The STD epidemic is"out of control," said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security."We know we are missing diagnoses. We know that contact tracing is happening late or not at all. If we're really serious about tackling the STD crisis, we have to get more people diagnosed."
The issue for regulators is whether sampling kits can be reliably adapted for in-home use. Unlike rapid antigen tests for COVID-19, which produce results in 15 to 20 minutes, the home STD kits on the market require patients to collect their own samples, and then package and mail them to a lab for analysis.
Hologic, Abbott and Molecular Testing Labs are among the companies urgently developing tests. And Cue Health, which sells COVID-19 tests, is poised to launch a clinical trial for a rapid home test for chlamydia and gonorrhea that would set a new bar, providing results in about 20 minutes. Everly Health and other companies described their kits as laboratory-developed tests, akin to the diagnostics some hospitals create for in-house use. And they contend their tests can be legally marketed because their labs have been certified by a different agency, the Centers for Medicare & Medicaid Services.
"Doing it by yourself is not hard at all," said Caldera, who is uninsured but receives the tests free through a community foundation."The instructions are really clear. I get the results in maybe four days. For sure, I would recommend it to other people."
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