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The machines for this test are not approved in the US. Secondly even if that was waived, there it the issue of getting the machines here, setting them up and tr
by pkaye 7y ago
The machines for this test are not approved in the US. Secondly even if that was waived, there it the issue of getting the machines here, setting them up and training people in the lab. And the reality is a huge number of countries also want these tests.
I've read however that FDA just approved a new test on Roche lab equipment which many labs already have.
https://www.cnbc.com/2020/03/13/scott-gottlieb-us-to-conduct-10000-coronavirus-tests-per-day-soon.html https://www.cnbc.com/2020/03/13/scott-gottlieb-us-to-conduct...
- sanxiyn 7y agoI used to think this, but it is not true. Surprising, I know. Here is FDA authorization for CDC test: https://www.fda.gov/media/134922/download https://www.fda.gov/media/134922/download. The required machine is Applied Biosystems 7500, and CDC targeted it because it is approved, widely available, trained on, etc. in USA. Here is product information page from one of South Korean test suppliers: http://www.solgent.com/english/sub03020102/view/id/45 http://www.solgent.com/english/sub03020102/view/id/45. It is compatible with Bio-Rad CFX96 and Applied Biosystems 7500, and was approved as such in South Korea. While Bio-Rad's machine is more popular in South Korea, they obviously thought of exporting.