THREAD: A brief review of Catch-22 when it comes to #Coronavirus and need for more diagnostic screening capability. Hospitals can roll out RT-PCR based test CDC developed. They all have Roche systems to run these tests. The technology is fairly straightforward. Here’s the rub 1/9 
Hospitals could advance these tests as Laboratory Developed Tests or LDTs, meaning they develop them in house. But since HHS declared a public health emergency related to #Coronavirus, hospitals are now expected to get FDA permission to use their own tests fda.gov/emergency-prep…
Following the public health emergency declaration, HHS is expected to issue a declaration justifying Emergency Use Authorization (EUA) to facilitate the development of diagnostics and therapeutics for #Coronavirus medtechdive.com/news/amid-coro…
LDTs for #Coronavirus would be considered to be “developed to diagnose serious or life-threatening diseases or conditions” and for “analyses of disease progression and public health decision making” per FDA guidelines and expected to get EUAs. So herein lies the Catch-22
We need to expand screening capability; the CDC lab that is currently sanctioned to run all these tests is taking 36-48 hours to turn around results. Moreover, it will be quickly overwhelmed in an outbreak. wsj.com/articles/new-y…
We also should expand triggers for screening to detect outbreaks early. Anyone with atypical viral pneumonia where multiplex respiratory viral panel is negative should probably be checked for #nCoV; not just those returning from China. But we don’t have screening capacity now
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. Our ability to detect secondary spread among people not directly tied to China travel is greatly limited.
Systems to run RT-PCR are well established. It’s run on Roche Diagnostics platform, a system every hospital lab has. Labs run thousands of such tests daily for broad range of viruses. They're technically straightforward and reliable if sample prep is good ncbi.nlm.nih.gov/pubmed/11884626
#FDA and #CDC can allow more labs to run the RT-PCR tests starting with public health agencies. Big medical centers can also be authorized to run tests under EUA. For now they're not permitted to run the tests, even though many labs can do so reliably 9/9 cdc.gov/coronavirus/20…
Note: Thermo Fischer also makes a commonly-used RT-PCR platform thermofisher.com/us/en/home/lif… as does Qiagen qiagen.com/us/products/di…, among others, and in addition to Roche. Cepheid makes a platform called GeneXpert for performing RT-PCR at the point of care cepheid.com
