Decentralization of healthcare is a major trend impacting the delivery of in vitro diagnostics and is driving the need for point-of-care testing/tests (POCT). With fast turnaround times (TAT) and portability to a variety of settings, POCT offers many advantages for disease management. POCT enables migration from core hospital labs to specialty-care units, doctors’ offices, and homes to provide access to healthcare services, thus improving patient compliance, reducing hospital stays, and lowering overall healthcare costs.
POCT is emerging as an important tool for more efficient diagnosis and patient evaluation. Increasing demand on the healthcare system — stemming largely from growing needs for chronic-disease management as the population ages — has led to economic pressure to reduce patient length of stay. POCT allows for rapid results, which can mean faster diagnosis, earlier identification of high-risk patients, and earlier discharge of low-risk patients — as well as improved clinical outcomes and cost savings.
Even though POCT brings about several key benefits, adoption by hospitals has lagged. Most hospitals take the position that to ensure optimal quality control, data interpretation, sample handling, accuracy, and sensitivity, testing should be carried out in core laboratories. This view is likely to change with the availability of more accurate POCT technologies/platforms, rising healthcare costs, and an ongoing labor shortage.
POCT is most prominent in primary-care, and surgical and acute-care settings. In these settings, as well as in high-level care units (e.g., intensive-care units), faster TAT can result in improved patient outcomes, shorter lengths of stay, increased patient satisfaction, and improved departmental efficiency. For example, the immediate TAT of blood gases and electrolytes are helpful in operating rooms and fast TAT cardiac tests are vital to managing critically ill patients in emergency rooms.
One limitation to the adoption of POCT is accuracy. Lateral-flow testing presents sensitivity and specificity issues in several infectious-disease areas. For example, during the H1N1 flu pandemic, hospitals reported sensitivity rates as low as 50%. In handheld instrument testing for glucose, problems relating to test performance, quality control, and reproducibility have contributed to lower accuracy. While of concern, these issues can often be addressed with better proficiency training and quality-control procedures.
Another limitation to the widespread POCT adoption is cost. In a comparative study performed by the State University of New York, the overall cost of POCT for glucose was compared to centralized glucose testing. The study, presented at the 2010 Annual Meeting of the American Association for Clinical Chemistry, shows that POCT had a higher overall cost per patient than centralized lab testing by sevenfold. One major contributor to the overall cost of POCT is labor — which includes the time for test performance and time for data reporting, which grows significantly when each sample is tested individually. In addition, extra procedures typically implemented for maintaining result accuracy and reproducibility (e.g., quality control, proficiency training, and credentialing) also add to the cost. In many institutions, additional personnel also are necessary to administer POCT. More automated and easy-to-use POC diagnostics are likely to cut added labor costs.
Technology advancements will be the key driver toward POCT adoption. The next generation of POC diagnostics will rely heavily on affordable, high-performance, easy-to-use readers, and assays with connectivity. Protein assays are moving away from lower sensitivity lateral flow tests to portable, user-friendly platforms based on microfluidics and technologies such as nanoparticle labeling and magnetic resonance-based detection — which promise lab-level ultra-sensitive detection. New, easy-to-use, random-access, short-time-to-result, and scalable molecular-diagnostic-based platforms exhibit the same accuracy in both lab and POCT settings. In addition, these new systems employ advanced software to automate or alert operators to perform quality control before a patient sample is analyzed. Furthermore, these new technologies have multiplex capabilities enabling detection of multiple parameters in a single sample, promising cost-effectiveness.
Connectivity is key to the effectiveness of POC systems. Many POCT programs can also link POC devices to centralized management stations and primary healthcare-information systems, so POCT results can easily be added to patients’ medical records. Many POCT devices have built-in memory that stores test results for later download into a computer or can send results to a receiving network.
POCT testing also will fill some gaps. POCT will be a key enabler of remote health monitoring. The increasing burden of chronic-disease management has led to the emergence of interactive remote health-management/-monitoring systems which reduce healthcare costs by preventing hospital readmissions. POCT also addresses the projected shortfall of qualified laboratorians. In recent years, many accredited programs in clinical laboratory science and medical technology have closed due to reduced enrollment, and decreasing numbers of students are graduating from the remaining programs. This trend, likely to continue well into the future, will expand the role of POCT.
Technology advancements, wider test menus, and improved quality control and data management promise lab-quality tests will soon be available at the point of care. POCT will be a key enabler of better patient management and an important tool for widespread access to healthcare.
Harry Glorikian, BA, MBA, is managing partner; Aruna Rajan is a senior associate; and Kerry Xie is a senior analyst at Scientia Advisors, a management-consulting firm specializing in growth strategies for healthcare, life sciences, biotechnology, and nutrition companies.
