直接面向消费者的测试是由消费者发起的测试:对测试过程的妥协和提高质量的机会。

IF 3.8 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY
Patti Shih, Sverre Sandberg, Jan Balla, Banu Isbilen Basok, Jennifer J Brady, Bernard Croal, Nathalie De Vos, Mathias Karlsson, Piret Kedars, Tomris Ozben, Marina Pijanovic, Mario Plebani, Matthias Orth
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引用次数: 0

摘要

直接面向消费者检测(DTCT)是指由非专业人员在没有医疗保健专业人员参与的情况下发起的商业实验室检测。随着这一市场规模的扩大和产品种类的增多,需要对 DTCT 进行明确的定义,以便将其危害和益处概念化。我们描述了三种不同的 DTCT 模式(家庭自我检测、自我采样检测和直接获取检测)如何对传统检测过程("脑-脑循环")提出警告,以及医疗实验室与非医疗实验室之间的区别。我们就如何提高 DTCT 的质量和减少错误提出了建议。DTCT 的潜在益处和害处无一例外地取决于消费者个人的背景和情况以及所涉及的检测类型。重要的是,应考虑对消费者和医疗系统的影响,如对改善健康结果、减少不必要的检查和临床资源使用的影响。消费者发起 "必须成为 DTCT 的一个核心定义特征,以便从实验室专家的角度明确划分这类检测的主要缺点和机遇。消费者主动检测 "的概念也应有助于界定 DTCT 的监管,并提供一个努力的方向,以支持消费者在没有临床医生把关的情况下作为购买和进行这些检测的主要决策者。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Direct-to-consumer testing as consumer initiated testing: compromises to the testing process and opportunities for quality improvement.

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.

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来源期刊
Clinical chemistry and laboratory medicine
Clinical chemistry and laboratory medicine 医学-医学实验技术
CiteScore
11.30
自引率
16.20%
发文量
306
审稿时长
3 months
期刊介绍: Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically. CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France). Topics: - clinical biochemistry - clinical genomics and molecular biology - clinical haematology and coagulation - clinical immunology and autoimmunity - clinical microbiology - drug monitoring and analysis - evaluation of diagnostic biomarkers - disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes) - new reagents, instrumentation and technologies - new methodologies - reference materials and methods - reference values and decision limits - quality and safety in laboratory medicine - translational laboratory medicine - clinical metrology Follow @cclm_degruyter on Twitter!
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