Point of care testing: evolving scenarios and innovative perspectives.

Rapid point-of-care testing (POCT) for blood gas analysis, glucose, electrolytes, prothrombin time and other parameters including cardiac biomarkers has been available for a long time and has now become a rather ordinary diagnostic tool worldwide. By nature, POCT is a disruptive solution since it permits the rapid delivery of laboratory information at the point of need, using small amounts of sample, and most typically with no need for blood centrifugation. The steady increase in availability of POCT instrumentation of different sizes and destinations of use has contributed to increased concerns about the quality of test results. Potential problems have been described throughout the testing process, and the connection between patient safety and POCT appears at the intersection of technical limitations, rapid availability of results and the immediate therapeutic implications that are allowed by this type of testing [1]. Errors in POCT are relatively common, and their frequency is amplified by incoherent legislation, scarce focus or compliance on quality assurance issues, and insufficient training of personnel outside the clinical laboratory [2–4]. The debate around the clinical effectiveness of POCT continues to grow, and it is magnified even more by the article of Pecoraro et al. [5] that appears in this issue of the journal. The authors reviewed 85 studies for five POCT instruments (i.e., neonatal bilirubin, procalcitonin, intraoperative parathyroid hormone, troponin and blood gas analysis) and concluded that, although this type of testing has the potential to generate favorable outcomes, additional evidence is needed before we can definitely establish whether or not POCT is really useful to the clinical decision-making process across different healthcare settings. Another article, recently published in the New England Journal of Medicine [6], has depicted a different scenario, concluding that POCT is increasingly being used especially in certain areas of limited resources for disease identification, prognostication and therapeutic monitoring. Even more importantly, it is also underscored that investments in this field of diagnostics are now starting to improve patient care. As frequently occurs in science and medicine, the truth probably lies somewhere in between these two apparently conflicting perspectives. The unarguable premise is that expansion of healthcare services is typically associated with an increased demand for diagnostic tests that may support screening, diagnosis, prognostication and therapeutic monitoring of human pathologies [7]. Under certain perspectives, classic diagnostic technologies may not be suited for meeting these expanded testing needs, since traditional laboratory testing requires complex infrastructures, controlled environment (e.g., temperature and humidity), skilled technicians and stable supplies (e.g., spare materials, electricity and water), but several of these aspects are not always available, especially in nonurban areas and in those areas plagued by natural disasters [8, 9]. Laboratory testing is typically performed in remote laboratories, and this places a substantial economical burden on the healthcare system, may be inconvenient for some patients and leaves a large number of patients undiagnosed after leaving the facility [6]. It is undeniable that the new generations of POCT, which are capable of targeting multiple biological pathways, include accurate biomarkers (e.g., nucleic acids and cell-surface markers) and take advantage of improvements in nanotechnology, microfluidics and wireless connection, which may produce a substantial and favorable impact on healthcare [10]. These devices not only enable a faster workup in the clinics but also, even more interestingly, allow reliable home-based and self-testing, even if we would all agree that additional evidence should be provided to definitely establish whether the appropriate use of POCT technology will really improve clinical outcomes for individual patients and communities, as highlighted by Jani and Peter [6]. In particular, normative bodies should provide recommendations on the most suitable approach for evaluating effective clinical needs, on the appropriate use of this technology (including guidance to ensure quality, avoidance of risk for patient safety, benefits and cost-effectiveness evaluation), on the policy for acquisition of the most suitable product according to the healthcare setting and