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Point-of-care testing: state-of-the art
andperspectiveshttps://doi.org/10.1515/cclm-2024-0675Received June 10, 2024; accepted June 10, 2024;published online June 17, 2024
Abstract: Point-of-care testing (POCT) is becoming anincreasingly popular way to perform laboratory testscloser to the patient. This option has several recognizedadvantages, such as accessibility, portability, speed, convenience, ease of use, ever-growing test panels, lowercumulative healthcare costs when used within appropriate clinical pathways, better patient empowermentand engagement, and reduction of certain pre-analyticalerrors, especially those related to specimen transportation. On the other hand, POCT also poses some limitations and risks, namely the risk of lower accuracy andreliability compared to traditional laboratory tests,quality control and connectivity issues, high dependenceon operators (with varying levels of expertise or training),challenges related to patient data management, highercosts per individual test, regulatory and compliance
issues such as the need for appropriate validation prior toclinical use (especially for rapid diagnostic tests; RDTs), aswell as additional preanalytical sources of error that mayremain undetected in this type of testing, which is usuallybased on whole blood samples (i.e., presence of interfering substances, clotting, hemolysis, etc.). There is nodoubt that POCT is a breakthrough innovation in laboratory medicine, but the discussion on its appropriate userequires further debate and initiatives. This collectiveopinion paper, composed of abstracts of the lecturespresented at the two-day expert meeting “Point-Of-CareTesting: State of the Art and Perspective” (Venice, April 4–5, 2024), aims to provide a thoughtful overview of thestate-of-the-art in POCT, its current applications, advantages and potential limitations, as well as some interestingreflections on the future perspectives of this particularfield of laboratory medicine.
Laboratory medicine: POCT and the brain-to-brain loop
Point-of-care testing (POCT) has been defined as a “medicaltesting at or near the site of patient care by healthcare professionals” [1]. The term “specially trained” can be added to“healthcare (non-laboratory professionals)” to recognize theevidence that most errors in POCT were and, possibly, are stilldue to the lack of knowledge or non-compliance with standardoperating procedures [2]. However, a narrower definition ofPOCT is “testing performed by the patients themselves” [3].While the former definition may maintain POCT withinthe traditional brain-to-brain loop [4], the latter seems tocharacterize POCT as a direct-to-consumer testing (DTCT), thuschanging the traditional framework which characterizes therelationships between laboratory professionals and physicians.In the new scenario, POCT should be used as a type of selfsampling and self-testing approach and, therefore, may requirefurther concern. The core principle underlying POCT measurements has been described as “reducing the turnaround
time (TAT) without compromising the quality of information”. Therefore, careful evaluation of analytical quality performances should be always performed when adopting POCT in clinical practice. Analytical performance specifications (APS)have been defined as “the level of performance required to facilitate clinical decision-making”, but if POCT is becoming a type of DTCT, even APS should be revised because customers cannot understand and appreciate the quality of results and the ultimate consequences for diagnosis and therapy. The evolving trend towards decentralized laboratory testing requires major concern, avoiding uncontrolled approaches and recommending an appropriate governance by laboratory professionals. This collective opinion paper, composed of abstracts of the lectures presented during the two-day expert meeting “Point-Of-Care-Testing: State of the Art and Perspective”(Venice, April 4–5, 2024), aims to provide a thoughtful overview of the state-of-the-art in POCT testing, its current applications, advantages and potential limitations, as well as some interesting reflections on the future perspectives of this particular area of laboratory medicine.
Point-of-care testing: state of the art for meeting patient needs in new ways
POCT is an increasingly popular means of conducting laboratory testing closer to the site of patient care [5]. POCT provides rapid turnaround of test results with the potential for more rapid clinical action that can improve patient outcomes [6]. Portability, ease-of-use, and minimal training requirements are some of the advantages of POCT. The convenience of testing closer to the patient is opening a variety of opportunities to provide healthcare in the community outside of hospitals and physician office clinics. Companies are marketing POCT devices to patients for home self-testing and through home collection kits with direct-access testing. Pharmacy walk-in clinics and doctor-on-call services provide more convenient means for patients to see a clinician without having to wait for an appointment from their primary care physician. The patient is in the driving seat, taking charge of their health and demanding healthcare services that meet their needs, at their convenience and timeframe. The coronavirus diseases 2019 (COVID-19) pandemic has opened new opportunities for telehealth, hospital-at-home, and concierge medicine services that require faster test result TAT. The future of POCT promises new sensors, wearable devices and smart technologies that are less invasive and can better connect the patient with their physician. The convenience and ease-of-use of POCT will find new applications and develop novel ways that laboratory diagnostics can improve patient outcomes in the future.
POCT in value-based healthcare
Value based healthcare (VBHC) is based on the equation outcome/costs. The calculation of costs should be performed on the whole cost of the process, not only on the cost of a single procedure, considering the outcome of the same process. The introduction and diffusion of POCT in clinical medicine is clearly enhanced by the possible improvement of outcome, principally due to the reduction of TAT, although the costs are usually higher than traditional analyses performed in centralized laboratories. There are few studies focused on the impact of POCT on the whole medical process; most are devoted to the analytical evaluation of instruments and methods, in comparison with traditional centralized analyses. There are some medical processes where the use of POCT could really modify outcomes and costs, with a beneficial effect on patients: the case of over-testing possibly inducing iatrogenic anemia is an example [78].
The use of POCT for periodical control of hemoglobin in patients hospitalized in critical areas could really decrease the volume of blood drawn and the risk of anemia. The perception of the positive impact of POCT in all medical processes, owing to immediate reports of results and their interpretation by physicians, is not supported by specific studies. The actual utilization in daily practice involves mainly a few tests for diagnosing and monitoring diabetes, determining urinary tract and other infections, and stratifying acute cardiac syndromes. For general practitioners, many POCTs are not useful as they test chronic or rather innocuous conditions. Practitioners are unwilling toadopt technologies that are not beneficial to patient care or for the profitability of their practices. Some applications of POCT are not really decreasing the time needed for medical decision making, as reported in published papers, and actually small modifications of central clinical laboratory organization should be sufficient to answer clinicians’ requests with minor costs. Conversely, in some cases clinical laboratory experts should facilitate the introduction of POCT testing, for example for direct oral anticoagulants (DOACs)testing before major surgery. Even in some specific scenarios, where POCT is generally accepted as the solution for obtaining laboratory results, in low resources healthcare(low middle-income countries, rural areas, desertification of healthcare in developed countries, disaster medicine), specific studies based on VHBC are needed, to avoid the increase of inequalities and unbalanced between beneficial effects and costs. There is a lack of complete, comprehensive, and global evaluation of the impact of POCT in healthcare settings. Ten years ago, we selected POCT with special analytes characterized by possible high clinical impact [79]. We analyzed 84studies for five POCT instruments: neonatal bilirubin, procalcitonin, intraoperative parathyroid hormone, cardiac troponin and blood gas analysis. Most of the articles (50 %)were studies of correlation between results obtained by using POCT instruments and those obtained with laboratory instruments. These data showed a satisfactory correlation between methods when similar analytical reactions were used.Only 13 % of the studies evaluated the impact of POCT onclinical practice. POCT decreases the time for making decisionson patient management, but the clinical outcomes have neverbeen adequately evaluated. The scenario has not changedsubstantially over time, and only a minority of studies arefocused on the impact on medical decisions, including aneconomical evaluation and cost effectiveness ratio.The very few health technology assessment (HTA) reports on POCT are characterized by negative evaluations,because the studies are performed only on analytical or, insome cases, on preanalytical/analytical aspects, avoiding the cost and outcome impact. Moreover, the type of healthcare service organization and reimbursement by the third payer are not, in general, properly considered. Thus, studies based on randomized clinical trials and HTA reports are compellingly needed for properly evaluating the use of POCT