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Contributed Commentary by Erin McCombs

September 18, 2017 | After years of alternating centralization and decentralization of diagnostic assays, we are finally entering an era of smart testing in which location is chosen based on what’s best for the patient.

Today, we see centralization and decentralization occurring as twin trends: some rapid tests are moving closer to the point of impact, while others are moving to large reference labs, where economies of scale can be brought to bear. In the past, where a test was performed was often decided by which labs were capable of running it. With the rise of rapid testing and easier to use platforms, many assays are no longer restricted by levels of expertise or the availability of certain technologies.

This is excellent news for clinical lab teams, physicians, and patients alike. It means that medical professionals will get answers more quickly when time to diagnosis is critical, while keeping costs low for less time-sensitive tests. From choosing the right treatment to identifying patients with dangerous, antibiotic-resistant infections, patient care and overall outcomes should improve with this development.

Shifting Landscape

For decades in clinical testing, the pendulum swung back and forth between centralization and decentralization. Tests originally conducted in big reference labs were moved to hospital-based labs and back, depending on economic forces and technology changes. For the most part, diagnostics were performed where they could be, not necessarily where they should be. While patient care is always important, the location of tests was often dictated by factors such as where reimbursement would be maximized, the high costs of diagnostic platforms, the volume of testing needed, and the technical complexity of the assays.

Until several recent developments in clinical diagnostics were made possible, what was in the patient’s best interest had not always been a primary factor in deciding where to run an assay. Molecular assays with faster turnaround time have been a game-changer, for example, letting hospitals or regional labs slash days off the typical time to results. Automated diagnostic systems that can be used in virtually any environment have been important too. These platforms dramatically reduce the hands-on time required, so bringing them into a clinical lab involves a much smaller investment of resources. They also handle most of the assay processing without human intervention, so it takes considerably less technical expertise to run each instrument. Diagnostic tools with greater flexibility have been instrumental as well; some handle both stat and batch testing, giving users much more control over capacity, while others incorporate new features such as the ability to mask and unmask results and only pay for the results you need.

With these advances, we have now reached the stage where smarter decisions can be made about where to run any given test. In hospitals, for example, antimicrobial stewardship programs have made tremendous strides by implementing rapid molecular testing in-house. These assays can deliver results in as little as a few hours — compared to two days or more with traditional culture-based testing — to ensure that patients get the most targeted antibiotic quickly or avoid antibiotics when they are unnecessary.

Meanwhile, higher-complexity tests for which results are not so urgent, such as routine prenatal cystic fibrosis assays, are moving to centralized reference labs. With samples pouring in from potentially hundreds or even thousands of sites, the sheer volume of demand gives these labs opportunities for maximum efficiency gains.

Importantly, in some cases, the same test can be run at both central and local labs. For instance, the routine screening of pregnant women for Group B Streptococcus during the 35^th to 37^th week of pregnancy is not very time-sensitive. However, in an emergency situation, such as premature delivery, the same test could be run at a local clinical lab to get results in time to decide whether or not to use prophylactic antibiotics on the baby. This is especially useful for patients in rural environments, where the nearest major academic medical center might be hours away, but a satellite laboratory is much closer.

Looking Ahead

There are other elements contributing to ongoing shifts in centralization or decentralization of tests, such as commoditization of assays (particularly for cases like flu testing) and consolidation of central laboratories. But the overall trend toward smart testing puts accommodating patient needs in the spotlight, and as a result, we will see improved care — as well as lower healthcare costs — as a direct outcome.