Direct-to-consumer testing as consumer initiated testing: compromises to the testing process and opportunities for quality improvement.

Autor:	Shih P; Australian Centre for Health Engagement Evidence and Values, School of Health & Society, 8691 University of Wollongong , Wollongong, Australia., Sandberg S; Noklus, Bergen, Norway.; Department of Public Global Health and Primary Care, University of Bergen, Bergen, Norway.; Noklus, The Norwegian Organization for Quality Improvement of Laboratory Examinations, Haraldsplass Diakonale Sykehus AS, Bergen, Norway.; Department of Public Global Health and Primary Care, University of Bergen, Bergen, Hordaland, Norway., Balla J; Klinicka biochemia a imunochemia, Analyticko-diagnosticke laboratorium, Kovacska, Presov, Slovakia., Basok BI; Faculty of Medicine, University of Health Sciences Izmir, Izmir, Türkiye., Brady JJ; Department of Clinical Biochemistry, Children's Health Ireland at Temple St, Dublin 1, Ireland.; School of Medicine, University College Dublin, Dublin, Ireland., Croal B; Aberdeen Royal Infirmary, NHS Grampian-Clinical Biochemistry, Aberdeen, Aberdeen, UK., De Vos N; LHUB-ULB Clinical Chemistry, Université Libre de Bruxelles, Bruxelles, Belgium., Karlsson M; Department of Medical Sciences, Section of Clinical Chemistry, Uppsala University, Uppsala, Sweden., Kedars P; Central Laboratory, East Tallinn Central Hospital, Tallinn, Harjumaa, Estonia., Ozben T; Department of Clinical Biochemistry, Medical Faculty, Akdeniz University, Antalya, Türkiye.; Faculty of Medicine and Surgery, Clinical and Experimental Medicine, University of Modena and Reggio Emilia, Modena, Italy., Pijanovic M; Laboratorija Medilab, Pozega, Republic of Serbia., Plebani M; Dipartimento di Medicina di Laboratorio, Universita di Padova, Azienda Ospedaliera di Padova, Padova, Italy., Orth M; Institut für Laboratoriumsmedizin, Vinzenz von Paul Kliniken gGmbH, Stuttgart, Baden-Württemberg, Germany.; Medical Faculty Mannheim, Ruprecht-Karls-Universität Heidelberg, Mannheim, Germany.
Jazyk:	angličtina
Zdroj:	Clinical chemistry and laboratory medicine [Clin Chem Lab Med] 2024 Aug 14. Date of Electronic Publication: 2024 Aug 14.
DOI:	10.1515/cclm-2024-0876
Abstrakt:	Direct-to-consumer testing (DTCT) refers to commercial laboratory tests initiated by laypersons without the involvement of healthcare professionals. As this market grows in size and variety of products, a clear definition of DTCT to ground the conceptualization of their harms and benefits is needed. We describe how three different modalities of DTCT (home self-testing, self-sampled tests, and direct access tests) present caveats to the traditional testing process ('brain-to-brain loop'), and how this might differ between medical vs. non-medical laboratories. We make recommendations for ways to improve quality and reduce errors with respect to DTCT. The potential benefits and harms of DTCT will invariably depend on the context and situation of individual consumers and the types of tests involved. Importantly, implications for both consumers and the healthcare system should be considered, such as the effects on improving health outcomes and reducing unnecessary testing and use of clinical resources. 'Consumer initiation' must be a central defining characteristic of DTCT, to clearly demarcate the key drawbacks as well as opportunities of this type of testing from a laboratory specialists' perspective. The concept of 'consumer initiated testing' should also help define DTCT regulation, and provide a locus of efforts to support consumers as the main decision-makers in the purchasing and conducting of these tests in the absence of clinician gatekeeping. (© 2024 Walter de Gruyter GmbH, Berlin/Boston.)
Databáze:	MEDLINE
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