At the Harvard Gazette Alvin Powell reminds us why inexpensive paper strip tests (referred to in an earlier post) aren’t presently being used. They’re illegal:
The Food and Drug Administration, in charge of approving diagnostic tests, has held up approval because the tests aren’t as accurate as nasal-swab, lab-based tests.
which is something I’ve been whining about for as long as I’ve had this blog and longer. The standard used by the FDA for approval preclude such tests. Even if there is a niche for their use a less expensive but less accurate testing method just can’t get approved. Medical diagnostic devices have an even higher hurdle to clear: they must be better than a human physician. “As good as” doesn’t get approved.
The way in which it is less accurate is important. If it just doesnt catch the virus when the load is low but is highly reliable when the load is higher, then the test would still have value. We could dial in accuracy at that point at which it is just becoming infectious. In that case a quick test becomes much more valuable that the test which is more “accurate” because it picks up lower viral loads, but takes days to get results.
Steve