The average teaching hospital could have had a usable test in place within a few weeks. Azar held them off with that emergency declaration. It is just now that widespread testing can begin. As soon as you had the gene sequence of the virus, a test could have been developed.Ken wrote:So how are we doing so far compared to other countries? Testing for the coronavirus in this country has been almost a farce so far: https://www.washingtonpost.com/health/w ... story.html
How do other countries manage to test thousands of people, then? What about using the test kits they use? The answer:A week later, the United States declared a public health emergency, a process designed to speed the development of diagnostic tests and other medical products. The CDC received the first “emergency use authorization” to make and distribute its test to the backbone of the public health system in the United States — mostly state labs.
But the emergency policy, intended to keep quality high, also discouraged hospital labs from quickly developing in-house tests. They would need specific approval from the FDA to do so.
“Since CDC and FDA haven’t authorized public health or hospital labs to run the tests, right now #CDC is the only place that can. So, screening has to be rationed,” Gottlieb tweeted on Feb. 2.
The CDC manufactured kits, and on Feb. 6 and 7, 90 test kits were shipped to the public health labs. Some labs began to have trouble with the test. On Feb. 12, the CDC announced the test was providing inconclusive results in some laboratories. The problem was in one of the three components of the test.
So it goes. Currently the US testing is too narrow to allow us to tell much anything about the possible spread of coronavirus in different areas. This means that we have no idea how correct the numbers of those infected might be. And then there is this bit:Some critics have questioned why the CDC didn’t switch to tests being used by other countries as soon as the problems arose, but the official said it would have taken longer to apply for a new authorization from the FDA and validate and manufacture a new test than it would to fix a test they knew worked in their own lab.
Wider testing for the virus is required to properly plan the need for hospital facilities and medical staff and for deciding when stronger quarantine policies might be in order. So far the US testing has been totally inadequate for these purposes. To put it into perspective:On Feb. 13, HHS Secretary Alex Azar testified before Congress that a limited five-city pilot would begin to add coronavirus to the usual flu surveillance system to see whether “there is broader spread than we have been able to detect so far.” But the plan was delayed because coronavirus tests weren’t available.
As of Sunday, 1,707 Americans had been tested for the novel coronavirus, according to the Centers for Disease Control and Prevention. South Korea, by contrast, has tested more than 189,000 people. The two countries announced their first coronavirus cases on the same day.
It seems that one of the controls in the CDC test kit failed fairly consistently, thus invalidating the whole batch run. The problem, I suspect was NIH (Not invented here). I will refrain from some of the theories that suggest it was to give commercial labs time to get into the game.
J.M.
