Evaluating the Quality and Reliability of Covid-19 Diagnostic Tests
I want to thank Dr. Naveen Agarwal for his excellent presentation last evening, May 21, 2020, to the South Atlantic Region. We had over 100 participants and some excellent follow-up questions. 

We can use this discussion group to continue to ask questions and elaborate on discussions as they relate to the Quality and Reliability of COVID-19 Diagnostic Tests. Dr. Agarwal has graciously consented to have his presentation available to ASQ members. See the attachment to this Post.

Remember: Dr. Agarwal is not a Medical Doctor. Questions specifically related to medical care or advice should be directed to *your* Healthcare Provider.

ASQ-Webinar-Covid19-Diagnostic-Test-Naveen-Agarwal-21May2020.pdf
4 Replies
Thank you for the opportunity Michael. 
This is an important topic in the current circumstances. I know we could not cover all the questions that were asked due to time constraints. I welcome a robust discussion here and will be happy to offer my insights on further questions or comments.
 
CDC has released "Interim Guidelines for COVID-19 Antibody Testing". This is a great follow-up to Dr. Agarwal's presentation.

While the news has hyped this report in a negative fashion, I was struck by the discussion about testing strategies - something that was touched on during the Q&A of our meeting. One of three strategies to improve positive predictive value - remember that from the presentation? - is "to employ an orthogonal testing algorithm in which persons who initially test positive are tested with a second test. Effective orthogonal algorithms are generally based on testing a patient sample with two tests, each with unique design characteristics (e.g., antigens or formats)." The report continues with a discussion of an example of an effective orthogonal algorithm.

I recommend this report everyone who attended the presentation. I looked at the report on May 27, 2020. The webpage for the report was last reviewed by CDC on May 23, 2020. 
@Naveen Agarwal, Can you recommend any “tutorial” type information (e.g., ASQ publication, basic textbook, websites) specifically on the design and analysis of tests used for medical tests such as COVID-19?

Thanks in advance.
Hi Michael Kirchner‍ - I am not familiar with any books on the specific topic of Covid-19 tests. This is still a very new field. I have learned a lot by reading the Letters of Authorization, Summary, and Instructions for Use for the tests that are authorized by the FDA. They are all available on the FDA website

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations

Although I have not reviewed it personally, FDA cites a standard CLSI EP12-A2 for calculation methods related to analytical sensitivity and specificity and their confidence intervals.

There are general books on molecular diagnostics, but I don't have any personal recommendations. 

Hope this helps.