Point-of-care testing in the era of value-based laboratory medicine

Abstract Point-of-care testing (POCT) represents a breakthrough technology in laboratory medicine that has expanded rapidly over the past three decades. Today, it accounts for approximately 25 % of all laboratory tests performed worldwide. POCT was initially implemented in critical care settings due to its substantial reduction in turnaround time (TAT), enabling more timely clinical decision-making and prompt therapeutic interventions. For selected measurands of high clinical value in critical care settings (e.g., blood gases, electrolytes, thromboelastography), the analytical performance of POCT is comparable to – and in some cases even exceeds – that of central laboratory testing. Subsequently, the adoption of POCT has expanded beyond critical care to encompass primary care, chronic disease management, community-based services, home care, and rural or remote healthcare settings, with the aim of improving access to laboratory testing. However, concerns have been raised regarding the accuracy and reliability of POCT results, as well as the compliance of their analytical performance specifications (APS) with current recommendations and clinical requirements. The aim of this paper is to discuss the current challenges in POCT and to develop a proposal grounded in a robust scientific and organizational rationale. This proposal is based on the distinction between Type A and Type B measurands and on the different roles of POCT for diagnosis and/or monitoring, according to the degree of APS compliance with established recommendations. For Type B measurands, the balance between improved access to diagnostics, acceptable analytical performance, and demonstrated benefits in clinical outcomes supports the adoption of POCT, particularly in selected settings where timely diagnosis and linkage to care are critical. Laboratory professionals must lead the appropriate and evidence-based adoption of this technological breakthrough by establishing fit-for-purpose and flexible quality control strategies, rigorously evaluating analytical performance specifications, and ensuring comprehensive oversight and governance across the entire testing process – from pre-analytical to post-analytical phases.