To defeat COVID-19, the FDA wants a new verification paradigm

To safely reopen economies and save long-term epidemics due to COVID-19, we want a paradigm shift in the way we think about diagnostic checks. With classic diagnostic controls for an infection, a patient has symptoms and a diagnostic check is performed to rule out or rule out a specific diagnosis. With COVID-19, a significant percentage of other people inflamed and a disproportionate number of people who transmit it are absolutely asymptomatic.

Therefore, to allow the immediate identity and self-quarantine of inflamed people, and to make it possible to locate contacts, we will have to verify asymptomatic people, and we will have to verify them several times because a user who is not inflamed one day can be inflamed the next. And I never knew. Testing should also be rapid, with rapid effects on the site to allow for a cause function; Take a look at an infection before boarding a plane, going to a nursing home or entering the workplace, factory, or other sensitive sites. COVID-19 diagnostic checks deserve to be fast, common, and widespread.

In contrast, Americans now have to queue for hours just to get a bachelor test, then wait days or even weeks, yet get effects, making their effects more historical than usable information, allowing the inflamed user to unknowlessly spread. and makes locating contacts virtually impossible.

Simply put, if the purpose is to save it or manage a pandemic involving a highly infectious but asymptomatic disease like COVID-19, then a very sensitive check that is administered only once to a small percentage of the population with days a week offering effects is a failed check, regardless of its accuracy.

So why don’t we have quick, non-invasive and common evidence? It’s not for lack of generation or innovation. At Columbia University Fertility Center and others, we have developed non-invasive diagnostic tests that can produce 30-minute effects on the box without the need for a beloved device or highly professional technicians.

The challenge comes from the FDA’s view of controls. Currently, the “gold standard” diagnostic check for the COVID-19 is the RT-PCR, which requires complicated and expensive machines, and is regularly performed in highly complex and long-overdue reference laboratories, and can take days to return to results. Any newly evolved check will necessarily have to paint as well as the ‘gold standard’. In the MIND of the FDA, it is better not to have verification than less accurate verification.

But a slightly less accurate verification performed several times and giving effects in a useful time frame is much more advantageous than a quick check performed once. To take an excessive example, he believes that a sensitive enough check to definitively diagnose other inflamed people 95% of the time, but done only once, and some other check that detects only 50% of positive cases, can still be repeated.

By the time you verify the same user 4 times more, the chances of 50% detecting the virus is 97%, already higher than the “more accurate” check. Add some additional data: that less sensitive verification can provide effects without delay compared to days or weeks, you can check many other people and the verification will probably be done closer to the time the user contracted the infection, and the 50% tact check does a much greater task of protecting the individual and society. Imagine what we can do with a 90% check.

COVID-19 is a very different type of virus and therefore the strategy to defeat it will also have to be different from what was done in the past. What is wanted now is a control that is possibly imperfect, but that can be administered continuously to the majority of the population and that has effects immediately. These checks exist. We just want the FDA to allow its use.

Zev Williams M.D., Ph.D., is Wendy D. Havens Associate Professor of Women’s Health and Head of Endocrinology and Reproductive Infertility at Columbia University’s Irving Medical Center.

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