Contributed Commentary By Sherry Dunbar, PhD
December 15, 2016 | Today’s healthcare decisions are becoming more and more reliant on molecular diagnostic tests. Whether it’s selecting the drug most likely to succeed for a specific patient, choosing the right dose based on a person’s metabolic profile, or determining the cause of a patient’s symptoms, these tests are enabling more accurate and personalized treatment than ever before. At the same time, the clinical labs responsible for running these important assays are under increasing budget pressures, especially as reimbursement remains an ongoing challenge. Labs everywhere are being asked to do more with less.
It is incumbent upon diagnostic platform developers to respond to this community need by designing instruments and assays that give customers more value for their investment. Based on my experience working in and with clinical labs, I believe the following features are most important for ensuring accuracy and reproducibility of results, while providing lab managers with more flexibility and increased capacity.
Instruments that run more than one type of test. One of the simplest and most effective ways of allowing clinical lab teams to accomplish more with less is having platforms that support several tests. The days of one platform for one assay are numbered; this is simply not a cost-effective solution for most cases. Instruments should be able to run assays for many different pathogens, diseases, or other analytes. It’s also very helpful for clinical labs when platforms can run both FDA-cleared in vitro diagnostics and laboratory-developed tests. The more flexible the instrument, the faster the lab can recoup its investment.
Platforms that can test an additional sample even when running. Time is a great enemy in clinical laboratories. Results must be reported to physicians as quickly as possible for optimal patient care, so every delay proves costly. Most diagnostic instruments today have the same limitation: once someone starts a run, the instrument cannot do anything else until the run is complete. Since each run can take hours, this often leads to a backlog of samples waiting to be tested. Some instruments, though, allow users to load new samples for testing even when they are in the midst of another run. This kind of approach makes it possible for clinical labs to respond more quickly to new orders, dramatically reducing the time physicians and their patients must wait for critical answers.
Carefully designed systems that help prevent error. Clinical lab teams are famous for their skill and attention to detail. Still, diagnostic developers should strive to build platforms that eliminate common sources of error. For instance, even in the best-run lab, it’s all too possible to load the wrong sample for an assay. Instruments can use features like barcoding to double-check that samples match the test they’re supposed to be run with, providing a safety net for an overworked lab member. These small adjustments decrease the likelihood of human error, save money and reduce the need to collect new samples from patients for retesting.
Streamlined workflows powered by better informatics. It’s a frequent joke in clinical labs that members get all the exercise they need running between instruments to check on test progress and results. Most diagnostic instruments have to be controlled with interfaces on built-in screens or attached computers, even when there is a lab information management system that could theoretically link them all together. There is simply nothing efficient about a workflow that requires lab personnel to go to each instrument in person to check the test result, write it down, and then go to another computer elsewhere in the lab and manually enter the information into a report for the ordering physician. Instruments that can be connected to the lab information system make much more sense: orders can be sent directly to the instrument, and results sent directly back to the lab manager to automatically populate a report. This saves time, eliminates the opportunity for error with manual data entry, and streamlines the lab’s operation. Moving toward a push-button workflow has the added advantage of simplifying the training process for new technicians, which pays dividends when labs go through the extensive validation and calibration testing required for ongoing clinical accreditation.
Tools that let clinical labs operate more efficiently and effectively translate directly into both better care for patients and cost savings for the lab. Even small advantages can have major impact. The best outcomes for clinical labs will be aided by diagnostic developers focusing on delivering innovative, flexible platforms to meet current and future challenges. Without this support, clinical labs at many institutions are operating on borrowed time as budgets shrink even further. For a robust clinical testing environment where local labs remain a centerpiece of excellent care, we must all work to make platforms flexible, cost-effective, and streamlined.
Sherry Dunbar, PhD, is Senior Director of Global Scientific Affairs at Luminex. She has a background in Clinical and Public Health Microbiology and was a clinical laboratory director prior to joining Luminex. In her current role, she oversees scientific and research activities related to the company’s genetic testing and infectious diseases molecular diagnostic portfolios. She can be reached at sdunbar@luminexcorp.com.