Point-of-Care Testing

Abstract

BACKGROUND P oint-of-care testing (POCT) is defined as medical testing at or near the site of patient care. 1-3 The first reported use of POCT appeared in the Ebers Papyrus dating from 1550 BC, in which Egyptian physicians used ants to determine glycosuria in patients suspected of having diabetes mellitus. The goal of POCT is to provide immediate, convenient, and easy-to-use diagnostic test(s) that shorten therapeutic turnaround time (TTAT) when providing patient care. Obtaining rapid diagnostic information allows for immediate clinical decision making, which improves patient safety and clinical outcomesnot to mention patient satisfaction. In the post-Medicare era, the model of centralized laboratory testing was developed and remained the norm until the mid-1980s, when new technologies were introduced and certain tests, most notably blood glucose and blood gases, began to migrate from the laboratory to patient care settings (Fig. 1). Although new instrumentation and methods have been developed that expand the laboratory industry's capabilities, the demand for rapid testing with shorter TTAT has prompted the significant increase in POCT. Since the evolution of blood glucose, blood gas, urinalysis, pregnancy, and coagulation testing in the mid-1990s, the POCT menu has expanded from less than 10 tests in 1995 to approximately 110 tests available today (Fig. 2). 4 In 2013, POCT represented 14% to 15% market share of the estimated $54 billion in vitro diagnostic (IVD) testing market, 5-10 and development of new technologies, such as lab-on-a-chip 11,12 and DNA-and RNA-based molecular diagnostic tests 13,14 are expected to further expand the POCT menu and increase utilization.Point-of-care testing is found in several care settings including hospital bedside, ambulatory care, alternate care (skilled nursing facilities), and the home (Fig. 3), and is used widely among major academic medical centers, hospitals, clinics, physician offices, and pharmaceutical clinical trial sites. Point-of-care testing also provides researchers with the ability to conduct double-blind studies using encrypted test results. It is important to note that POCT is not limited to the laboratory and includes physical tests such as weight, digital blood pressure, neurological tests, for example, carpal tunnel diagnostic test, and others. With the advent and expansion of retail pharmacies, certain point-of-care (POC) tests have benefit in supporting immediate treatment. Beyond glucose, POCT in the home-such as international normalized ratio-is positioned for major growth related to support management of chronic disease and companion diagnostics to support patient care. This is particularly important as the health care paradigm shifts to an accountable-care model focused on managing chronic diseases more effectively and providing preventive medical and wellness-based care.As summarized in Figure 4, care settings for POCT differ significantly regarding what is tested, who can perform the test, how the data are processed, and how the setting is regulate...