Steve Halasey, CLP.
From the 50,000-foot level, the prospect of a truly comprehensive diagnostic system capable of near-patient testing with rapid results is extremely attractive. It seems unlikely that there is a laboratorian anywhere in the world who wouldn’t jump at the chance to use an original Tricorder, with all of its capabilities, before declaring, inevitably, “He’s dead, Jim.”
But seriously, the moment that one contemplates implementing POC testing on any sort of scale, problems begin to crop up.1 In a sense, the widely touted benefits of POC testing—rapid rule-in/rule-out, low cost, and potential for CLIA-waived status, among many others—are in direct conflict with a wide range of systemic limitations that diminish the overall effectiveness of POC testing for guiding patient care.
Take, for example, the highly regarded capability of POC tests to expand the range of settings in which diagnostic testing can be performed. In recent years, advanced POC technologies have made it possible to perform POC testing in nontraditional settings that are still recognized as clinical sites—emergency departments, physician offices, long-term care environments—as well as in settings that are emphatically not clinical—accident sites, retail stores, and even patients’ homes. But such an expansion into nontraditional settings also brings with it the likelihood that the tests will be performed by nontraditional operators who may not have any significant training in the proper techniques required to collect and process a sample. Test developers continue to work toward CLIA-waived tests as a means of addressing this issue—but not every test has proven amenable to such treatment.
Other aspects of POC testing are receiving equivalent effort to address potential issues. The accuracy and precision of POC tests are generally not as good as laboratory tests, for instance, but emerging generations of instrumented immunoassays and molecular diagnostics are approaching that level of performance. In addition, FDA has shown that it is willing to grant CLIA-waived status to such instrumented assays, on a test-by-test basis.
POC testing is also vulnerable to a range of performance monitoring issues related to quality control, calibration verification, analytical measurement range verification, and method comparability against both POC and lab devices. And as more types of POC platforms and tests are developed, problems related to data management and oversight—including operator training and proficiency testing—can become important.
For all of these reasons, clinical laboratorians are likely to remain an important part of the process for selecting, adopting, managing, and performing POC testing. In this issue of CLP, several articles look at the ways that POC tests are being developed and implemented for the benefit of patients, providers, and the healthcare system as a whole. Whatever their role may be today, laboratorians owe it to themselves to keep abreast of such advances in POC testing, as it seems inevitable that they will be called upon to incorporate these technologies into their everyday routines.
REFERENCE
- Santrach PJ. Current and Future Applications of Point-of-Care Testing . Rochester, Minn: Mayo Clinic, n.d. Available at: https://wwwn.cdc.gov/cliac/pdf/addenda/cliac0207/addendumf.pdf. Accessed November 14, 2017.
Steve Halasey
Chief Editor, CLP
[email protected]
(626) 219-0199
