The FDA's advisory panel on diabetes was divided this past summer on whether to recommend approval of a point of care diabetes testing diagnostic assay. Interestingly, the product at issue – by Avere – was not being scrutinized for problems with less accurate (than traditional lab based testing) results. Avere's point of care results were found to be as accurate as those produced by a lab. It is unclear to me whether this is because Avere offers superior training to its clinical users or because the quality of American lab work has been compromised by severe lab staffing shortages. The larger concern appears to have been mostly with false positives on a diabetes diagnosis. Yet, other countries that routinely use point of care diabetes testing do not report an epidemic of false positives from that testing. Indeed, in the U.K. there is some evidence that point of care diabetes testing is considered the norm for in-patient settings and of interest in out-patient if the business case can be made for the equipment's use.
In fact, the larger issue is cost. Because it is administered by those clinically trained and not laboratory trained, point of care diabetes testing (depending upon the venue) can be considerably more expensive than lab based testing. But do these cost calculations factor in the cost of those suspected of diabetes, given a lab slip, pointed in the direction of the lab, and who never follow through? Does the cost to their health factor in here? What about the cost to patient health of doctors who never follow up on lab work that is ordered and completed, either through oversight or through lab reporting error?
I have to wonder if the utility and cost of point of care diagnostic diabetes testing is being measured against laboratory testing conducted in some perfect alternative universe none of us actually inhabit.