Could this improve the use of diagnostic cutoffs?

topical areas diagnosis
8

Are lab scientists and test developers making an error by relying on sens/spec to evaluate their procedures? That is where I’m confused. I don’t think so, but then the published testing evaluation statistics are very limited for a clinical context.

Added after Frank’s reply just below
FWIW, I can understand the sub-optimal use of sens/spec in the development of diagnostic tests, considering this FDA guidance document from 2007. I haven’t found anything more recent after a brief search this morning.

Related to diagnostic testing broadly

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/statistical-guidance-reporting-results-studies-evaluating-diagnostic-tests-guidance-industry-and-fda

Related to PCR tests specifically

While I’m pretty sure the diagnostic info could be incorporated in a more informative way, I am not yet convinced standard practice conveys 0 information to physicians. If anyone has an example, I’d appreciate it.

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