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Monday, May 18, 2020

ASQ webinar on Covid19 assay QA

Better late than never. These new coronavirus tests have been rife with error.


Testing is dominating our conversation during the current Covid-19 crisis as we think about reopening our economy. FDA has rapidly authorized nearly 100 different tests for emergency use to help detect, diagnose, and treat the infection caused by the novel coronavirus. There is widespread concern about the quality and reliability of these tests because of the perception that the FDA has relaxed the normally stringent requirements for performance validation.

In this webinar, the focus will be on recently authorized serology tests for the detection of antibodies and review their reported performance. The presenter will discuss how we can assess the level of uncertainty and risk when these tests are used for population serological surveys. Finally, the presenter will share thoughts on current misconceptions about testing and how Quality professionals can help facilitate a more informed public conversation and awareness.

Free, but name and email address registration required. I signed up to attend. From the email notice, it's obviously available to all ASQ members, but whether registration extends to the public at large is not clear.

I've been harping on the testing validation issues for more than two months. See here as well. My ASQ (in particular the BioMed Division) has been MIA up to now.

COVID-19 Testing
Currently available tests for COVID-19 are imperfect but useful if used properly, with rapidly evolving research on new tests underway.

As states are beginning to phase out total lockdown in the US, there is much discussion about how best to do it, minimizing the chance of causing a resurgence in COVID-19 cases. Just about every expert questioned about this topic focuses on testing – we have to do lots of testing in order to track people who have the disease, trace their contacts, and isolate them. At its core the idea is simple – instead of isolated everyone, we isolate those who have the virus, but in order to do that we have to know who has it and who doesn’t. Symptoms are one guide, but you can have the virus and pass it on without displaying symptoms. Therefore testing is critical. Some experts estimate we will need to do millions of tests per day to safely open up.

What is the state of our testing technology, and how reliable is it? There is a lot of work in this area, so this is a rapidly moving target, but some recent reviews help put things into perspective…
BTW, the Wiki has a nice, detailed entry on Covid-19 assay technologies, methodologies, and issues.


It was good, notwithanding the CusterFluck Webex interface login and recurrent bandwidth issues.

Niec presentation deck.

I would say, in deference to his Copyright, contact the author for the slide deck. He has lots of good stuff on his site. Attendees all got pdf access to it, but I don't want to usurp his show.

All good information, but nothing much I'd not already addressed in detail. I was looking for useful particulars on assay tech/methodology R&D QA and SARS-CoV-2 screening deployment workflow QA. They remain substantive concerns.

More to come...

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