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.
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.
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.
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.