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作为消费者发起的测试,直接向消费者进行测试:对测试过程的妥协以及质量改进的机会

Patti Shih¹, Sverre Sandberg^2,3,4,5, Jan Balla⁶

¹Australian Centre for Health Engagement Evidence and Values, School of Health & Society, 8691 University of Wollongong , Wollongong, Australia.

Clinical chemistry and laboratory medicine

|August 14, 2024

概括

消费者直接测试 (DTCT) 涉及消费者在没有医疗保健专业人员的情况下订购实验室测试. 通过"消费者启动"来定义DTCT,澄清了这些不断增长的商业测试的好处,危害和监管需求.

科学领域:

实验室医学实验室医学
消费者健康消费者健康
卫生政策卫生政策

背景情况:

消费者直接测试 (DTCT) 是一个不断增长的商业实验室测试市场,由个人在没有临床医生的参与的情况下订购.
扩大DTCT需要一个明确的定义,以了解其潜在的危害和益处.
现有的定义可能无法完全捕捉各种DTCT模式的细微差别.

研究的目的:

通过强调"消费者启动"作为核心特征来定义直接向消费者测试 (DTCT).
分析不同的DTCT方式如何影响传统的实验室测试过程.
为提高DTCT质量和减少错误提出建议.

主要方法:

对DTCT模式的概念分析:家庭自我测试,自我样本测试和直接访问测试.
将DTCT与传统的,临床医生订购的实验室测试 ("脑到脑循环") 进行比较.
检查对消费者和医疗保健系统的影响.

主要成果:

三种DTCT模式对标准化测试途径提出了独特的挑战.
医疗和非医疗实验室之间的区别在DTCT中很重要.
"消费者启动"被认为是DTCT的一个关键差异化因素.

结论:

以"消费者启动"为中心的明确定义对于理解DTCT的缺点和机遇至关重要.
这一定义可以为DTCT监管提供信息,并指导支持消费者做出明智决策的努力.
考虑对健康结果和医疗保健资源利用的影响至关重要.

关键词:

消费者发起的测试是消费者发起的测试.直接向消费者进行的测试.在体外设备规范规范.医疗过度使用总体测试过程的测试过程.

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