Conversation

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
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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
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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.
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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
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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
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This is so critical. If H2H outbreaks are already occurring and growing, we might not even know until it’s completely out of control! At this point most infections wouldn’t even have a direct link to China. This alone could make or break the success of containment here.
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