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Related: Editorials & Other Articles, Issue Forums, Alliance Forums, Region ForumsThis Scientist Created a Rapid Test Just Weeks Into the Pandemic. Here's Why You Still Can't Get It.
David Paltiel, a professor at the Yale School of Public Health, said a significant part of the problem is that the FDA created a detailed roadmap for tests that give patients a close-to-definitive answer on whether they have COVID-19, but never created a separate framework for rapid tests that serve a different purpose: helping people get frequent, fast evidence of whether they may be contagious.
The FDA wanted to see fewer false positives, even though people who test positive on an antigen test are usually advised to confirm it with a PCR. And while the overall sensitivity of E25Bio's test was lower than other tests would later demonstrate, it measured 100% for people with higher viral loads - those most likely to be infectious.
Beginning in the late summer of 2020, a coworking lab space in Cambridge where E25Bio had launched started a trial with 257 of its users who agreed to take both the antigen rapid test at home and a PCR test twice a week.
"As we commercialize our COVID-19 rapid tests internationally, we are also focused on developing the next generation of rapid tests for consumer diagnostics," an E25Bio spokesperson said, while declining to comment on Bosch's departure or its current product pipeline.
https://www.propublica.org/article/this-scientist-created-a-rapid-test-just-weeks-into-the-pandemic-heres-why-you-still-cant-get-it
hlthe2b
(102,357 posts)But in the public's hands and lesser informed health professionals, (the former who would never correctly use it as an immediate indicator of infectivity that could change in hours or days), a nightmare.
It would be very useful for spot testing before events, however. But, I get why FDA made their call--at least at the time.
stopdiggin
(11,358 posts)factor really deserved a lot of support or backing. Especially with messaging being so muddled and scattershot early on. Fear and misinformation were (and are?) also an enemy needing serious consideration. Hindsight and all that ... But I'm not sure the 'establishment' really made a wrong call on this.