The DARK Daily reports that a CLIA waiver has been obtained for a point-of-care test (POCT) for lead and then discusses the implications for the clinical labs of the continuous expansion of the POCT test menu (link here). Here is the link to Magellan Bioscience, the vendor of this test. Below is a quote from the DARK Daily commentary (boldface emphasis mine)
DARK Daily predicts that much of the new diagnostic technology soon to hit the market will make it simple and reliable to perform certain diagnostic tests outside the core laboratory....As more testing can be done in near-patient settings, the test mix in core laboratories is likely to shift away from routine testing and toward more complex reference and esoteric testing. Laboratories will have to adjust their focus so that these tests are viewed as their primary source of revenue. As point of care tests become more popular, laboratories may also want to play the "If I can’t beat 'em, I'll join 'em" game and develop mobile units to administer point-of-care tests.
It's interesting to speculate about the implications for hospital labs of the expansion of the POCT menu -- here are a few of my ideas about this topic:
- I have always believed that many lab professionals adopt POCT programs unwillingly because this approach to testing runs counter to the common lab paradigm that specimens travel to the central labs and then test results are published using the LIS. This lab culture needs to change as the POCT test repertoire continues to expand.
- I agree with Robert Michel that "the test mix in core laboratories is likely to shift away from routine testing and toward more complex reference and esoteric testing." However, it's useful to consider whether the most popular molecular diagnostic tests of the future can and will be performed in the majority of hospital labs. One issue will be the complexity of the tests and whether kits to perform such tests will be available for small to mid-size labs. A second issue is whether the developers of such tests will allow them to be performed by smaller labs as opposed to in-house performance or the transfer of such tests to a small network of affiliated labs ("centers of excellence").
- The concept of "mobile labs" has always interested me. Multiple POCT devices could be installed on a cart that would then be rolled to various outpatient locations. Tests would be performed as needed and the results would be routed to the LIS via a Wi-FI connection. The problem with this idea, as opposed to a fixed POCT lab in the OR or the ED, is that it requires multiple locations in a hospital with asynchronous "bursty" demand for lab testing. Such a demand pattern for testing is unusual.