Point-of-care testing, near-patient testing and patient self-testing: warning points

• Published in: Clinical chemistry and laboratory medicine Vol. 62; no. 12; pp. 2388 - 2392
• Main Authors: Banfi, Giuseppe, Božič, Borut, Cihan, Murat, Pašalić, Daria, Pennestrì, Federico, Plebani, Mario
• Format: Journal Article
• Language: English
• Published: Germany De Gruyter 26.11.2024; Walter De Gruyter & Company
• Subjects: Cost effectiveness; Ethical standards; ethics; Health care; International standards; Medical personnel; near-patient testing; patient self-testing; Patients; Point of care testing; quality; Regulation; Risk assessment; safety; Self testing; point of care testing; patient self-testing; ethics; safety; near-patient testing; quality
• DOI: 10.1515/cclm-2024-0525
• ISSN: 1434-6621; 1437-4331

Point-of-care testing (POCT), near-patient testing (NPT) and patient self-tests (PST) are diagnostic examinations performed at the time and place of patient care. While POCT and NPT are performed and analyzed by medical professionals, PST are based on samples and parameters directly collected and analyzed by lay users. These tests are spreading both in high income countries and in low to middle income countries as they are expected to improve healthcare efficiency and equity, by saving resources, releasing pressure from hospitals and reducing logistical barriers. However, accurate multidisciplinary assessment is mandatory to ensure that what they promise is real. We reviewed some important ethical aspects, international standards and regulations. The current risks associated with alternative ways of testing are explained by the principles of respect for patient autonomy and non-maleficence. Further evidence from multidisciplinary assessment is needed to evaluate pros and cons in light of the principles of beneficence and justice. Although POCT or NPT need common regulation and accurate provider training to ensure safe and appropriate interpretation of results, PST needs even more attention as they are subject to direct patient use. Randomized controlled trails including patient education should be conducted in order to provide reliable evidence on clinical outcomes, patient acceptance and cost-effectiveness. Mandatory regulation is needed to avoid harm and EU regulation should help different countries maintain a safe use of devices in a global population of producers and users.