[Goose]

Were there any problems with the CDC Ebola RT-PCR test?  This narrative doesn't raise any issues (though it is from the CDC website):

https://www.cdc.gov/vhf/ebola/history/20...index.html

Overall, eleven people were treated for Ebola in the United States during the 2014-2016 epidemic. On September 30, 2014, CDC confirmed the first travel-associated case of EVD diagnosed in the United States in a man who traveled from West Africa to Dallas, Texas. The patient (the index case) died on October 8, 2014. Two healthcare workers who cared for him in Dallas tested positive for EVD. Both recovered.

On October 23, 2014, a medical aid worker who had volunteered in Guinea was hospitalized in New York City with suspected EVD. The diagnosis was confirmed by the CDC the next day. The patient recovered.

For the original SARS virus, it was the CDC that announced the sequence: https://www.cdc.gov/sars/lab/sequence.html (after it was found to be a new coronavirus on the basis of Joe DeRisis' viral chip).

The CDC seems to have developed a MERS test without a problem:
https://www.cdc.gov/coronavirus/mers/lab...sting.html


[*]

Most state laboratories in the United States are approved to test for MERS-CoV by using an rRT-PCR assay developed by CDC. This test is done under authority of an Emergency Use Authorization because there are no FDA-cleared/approved tests available for this purpose in the United States.

As best I can tell, the problems with testing were unique to SARS-CoV-2, and don't seem to be reflective of a systematic problem developing molecular tests at CDC.

BC

EDIT: Note, this post was in response to Goose's now-deleted post, suggesting that the CDC in prior administrations had trouble developing PCR tests.

[*]Hi BC. I deleted my post for other reasons. The test the CDC developed was fine, as far as I know. The problem was, and remains, they were in no way prepared to deliver it nationwide in adequate quantity to use in conjunction with high capacity testing machines. That was the failing, and it was extremely significant and extremely predictable, The CDC has a very good track record of developing tests that can be used on epidemics that are small and controllable. They probably expected this one, initially, to fit that pattern. It didn't, and they had no capacity to meet the need. They had no relationship with Roche, Abbott, etc to deploy large scale tests that would work on the high capacity machines. The CDC also failed to validate some reagents in their tests. Simply not good. The director couldn't bring himself to say it. Fauci could.
[*]

I don't think I ever said they couldn't develop a test. What I did say is that in prior administrations as well as the present one they had no plan to deliver a nationwide test in short order and could not in fact do so. If such a plan ever existed to qualify their tests for large capacity machines and a GMP facility they intended to use to deliver it, I am all ears.

[Goose]

Were there any problems with the CDC Ebola RT-PCR test?  This narrative doesn't raise any issues (though it is from the CDC website):

https://www.cdc.gov/vhf/ebola/history/20...index.html

Overall, eleven people were treated for Ebola in the United States during the 2014-2016 epidemic. On September 30, 2014, CDC confirmed the first travel-associated case of EVD diagnosed in the United States in a man who traveled from West Africa to Dallas, Texas. The patient (the index case) died on October 8, 2014. Two healthcare workers who cared for him in Dallas tested positive for EVD. Both recovered.

On October 23, 2014, a medical aid worker who had volunteered in Guinea was hospitalized in New York City with suspected EVD. The diagnosis was confirmed by the CDC the next day. The patient recovered.

For the original SARS virus, it was the CDC that announced the sequence: https://www.cdc.gov/sars/lab/sequence.html (after it was found to be a new coronavirus on the basis of Joe DeRisis' viral chip).

The CDC seems to have developed a MERS test without a problem:
https://www.cdc.gov/coronavirus/mers/lab...sting.html


[*]

Most state laboratories in the United States are approved to test for MERS-CoV by using an rRT-PCR assay developed by CDC. This test is done under authority of an Emergency Use Authorization because there are no FDA-cleared/approved tests available for this purpose in the United States.

As best I can tell, the problems with testing were unique to SARS-CoV-2, and don't seem to be reflective of a systematic problem developing molecular tests at CDC.

BC

EDIT: Note, this post was in response to Goose's now-deleted post, suggesting that the CDC in prior administrations had trouble developing PCR tests.

[*]Hi BC. I deleted my post for other reasons. The test the CDC developed was fine, as far as I know. The problem was, and remains, they were in no way prepared to deliver it nationwide in adequate quantity to use in conjunction with high capacity testing machines. That was the failing, and it was extremely significant and extremely predictable, The CDC has a very good track record of developing tests that can be used on epidemics that are small and controllable. They probably expected this one, initially, to fit that pattern. It didn't, and they had no capacity to meet the need. They had no relationship with Roche, Abbott, etc to deploy large scale tests that would work on the high capacity machines. The CDC also failed to validate some reagents in their tests. Simply not good. The director couldn't bring himself to say it. Fauci could.
[*]

I don't think I ever said they couldn't develop a test. What I did say is that in prior administrations as well as the present one they had no plan to deliver a nationwide test in short order and could not in fact do so. If such a plan ever existed to qualify their tests for large capacity machines and a GMP facility they intended to use to deliver it, I am all ears.