BTW,
I found this:
https://www.cnn.com/2020/03/04/health/coronavirus-test-what-happens-explainer/index.html
Also:
...
Even if that number were accurate, 1 million tests does not necessarily mean 1 million people tested. Labs are running two tests per patient, as ProPublica reporter Caroline Chen points out.
The Centers for Disease Control and Prevention (CDC) created its own test for the novel coronavirus at the start of the outbreak. The agency was quickly able to start testing samples at its central lab in Atlanta. However, testing capacity stalled out when they tried to get testing kits out to local labs: one part of the test kits was contaminated, and the labs weren’t able to validate that they worked. The FDA did not give state labs permission to create their own test, instead of relying on the CDC’s, until February 29th.
In addition, until last week, the CDC only recommended testing for people who had either traveled to a country where the virus was spreading or who had been in contact with someone who had a confirmed case of COVID-19. That’s why, for example, two patients in Washington state were not diagnosed with COVID-19 until a week after their death.
...
Typically, there are few confirmed viral samples from patients at the outset, which researchers need to validate their tests, and CDC has the capability to grow the virus for this critical quality assurance step. Once the agency has a working test, that goes out to state labs. Then, in a third phase, commercial labs take over and either produce their own tests or scale-up the CDC one. “I would have hoped to see that third phase by now,” Borio says.
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CDC finally started to send kits to state and local health labs on 5 February. But on 12 February, it revealed that several labs had difficulty validating the test because of a problem with one of the reagents.
The key problem with the kits is what’s known as a negative control, says Kelly Wroblewski, director of infectious diseases at the Association of Public Health Laboratories (APHL). CDC’s test uses the polymerase chain reaction (PCR) assay to find tiny amounts of the SARS-CoV-2 genome in, say, a nose swab. To make sure a test is working properly, kits also include DNA unrelated to SARS-CoV-2. The assay should not react to this negative control, but the CDC reagents did at many, but not all, state labs. The labs where the negative control failed were not allowed to use the test; they have to continue to send their samples to Atlanta.
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In principle, many hospital and academic labs around the country have the capability to carry out tests themselves. The PCR reaction uses so-called primers, short stretches of DNA, to find viral sequences. The CDC website posts the primers used in its test, and WHO publicly catalogs other primers and protocols, too. Well-equipped state or local labs can use these—or come up with their own—to produce what are known as a “laboratory-developed tests” for in-house use.
But at the moment, they’re not allowed to do that without FDA approval. When the United States declared the outbreak a public health emergency on 31 January, a bureaucratic process kicked in that requires FDA’s “emergency use approval” for any tests. “The declaration of a public health emergency did exactly what it shouldn’t have. It limited the diagnostic capacity of this country,” Mina says. “It’s insane.”
On 24 February, APHL asked FDA Commissioner Stephen Hahn for “enforcement discretion” to sidestep the emergency process and allow APHL members labs to use their own tests. On 26 February, Hahn replied that the CDC test could be modified to use just the primers that specifically detect SARS-CoV-2, essentially ignoring the faulty portion of the kits. FDA, in other words, would look the other way to make more widespread testing possible.
I am really too tired to read all this, but I will tomorrow.
Thank you for taking time to reply.
Freegards!