How it works, why we need it, and why it’s taking so damn long for the US to get people diagnosed.

How it works, why we need it, and why it’s taking so damn long for the US to get people diagnosed.

In principle, any certified lab in the US with the right equipment could have followed suitincluding hospitals and commercial labs. All theyd need to do is use any one of the protocols publicized by the WHO as a guide for ordering primers from any number of DNA synthesis companies and push forward with testing. But in reality, they were paralyzed, stuck behind a wall of freshly stretched red tape, able only to wait on the CDC to ship more kits.
See, when federal health authorities declared Covid-19 a public health emergency back in January, it triggered a set of rules requiring any tests to pass the FDAs emergency use approval process. These rules raise the bar for tests developed and run inside a single laboratory. In a non-emergency situation, the FDA generally stays away from regulating these kinds of tests. But under the emergency rules, any lab that wanted to test for Covid-19 had to perform a number of validation studies and submit data to the FDA for review. These require viral specimens, which can be hard to obtain if youre not the CDC.
For consistencys sake, the FDA opted to limit its initial emergency approval to just the CDC test, to ensure accurate surveillance across state, county, and city health departments. The testing strategy the government picked was very limited. Even if the tests had worked, they wouldnt have had that much capacity for a while, says Joshua Sharfstein, a health policy researcher at Johns Hopkins School of Public Health and the coauthor of a recent journal article on how this testing system has gone awry. They basically were saying, were going to use a test not only developed by CDC, but CDC has to wrap it up and send it to the lab, and its just going to be state labs doing it.
The effect was that the nations labs could only run tests using the CDCs kits. They couldnt order their own primers and probes, even if they were identical to the ones inside the CDC kits. And when the CDCs kits turned out to be flawed, there was no plan B.
But no one outside the government yet knows why, at that moment, the US didnt switch to a test developed for the WHO, in use in more than 120 countries. A spokesperson for the WHO declined to answer that question, and US policymakers like Health and Human Services secretary Alex Azar have repeatedly dodged it. It might have been straight-up bureaucracygetting that test approved for use in the US might have taken too long. Some people suspect the answer may be politics. Speaking to the NPR program Fresh Air, Dan Diamond, health policy reporter for Politico, claimed that President Donald Trump had intentionally slow-walked testing deployment because higher numbers would jeopardize his reelection campaign.
On February 29, facing mounting pressure to expand testing capacity in the face of a growing public health catastrophe, the FDA changed its regulations to allow certified clinical labs to develop and begin using their own tests to detect Covid-19 without prior approval. As soon as they found community transmission cases on the West Coast, that was a wake-up call, Sharfstein says. By the end of the week, the FDA just said, Get started.
Under the new policy, the FDA review will still be required, but labs will have two weeks to send data to the FDA after internally validating the tests. In the meantime, they can start using their diagnostics to test patient samples.
With the relaxed protocols, two of the largest diagnostic commercial labs, Quest Diagnostics and LabCorp, have begun conducting a few thousands tests a day, according to data compiled by the American Enterprise Institute. (LabCorp representatives didnt return a request for comment, but a spokesperson for Quest says the company expects to have the capacity to conduct tens of thousands of tests per week by the end of March.) Universities and hospitals have also booted up.

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