评估直接向消费者提供肠道微生物组测试服务的分析性能
Stephanie L Servetas1, Kristine S Gierz2, Diane Hoffmann3
1Complex Microbial Systems Group, Biosystems and Biomaterials Division, National Institute of Standards and Technology (NIST), Gaithersburg, MD, USA. stephanie.servetas@nist.gov.
Communications biology
|February 26, 2026
概括
直接向消费者 (DTC) 微生物组测试显示了肠道健康分析中的重大不一致性. 方法的变化和质量控制的差异破坏了这些受欢迎的健康和健康产品的可靠性.
科学领域:
- 微生物组研究的研究.
- 消费者健康产品 消费者健康产品
- 分析化学是一种分析化学.
背景情况:
- 消费者对个人微生物群健康的兴趣日益增长.
- 直接向消费者 (DTC) 提供微生物组测试服务的扩散.
- 关于DTC测试的分析有效性,临床有效性和安全性的不确定性.
研究的目的:
- 评估DTC肠道微生物组测试服务的性能.
- 识别供应商内部和供应商之间的结果差异.
- 突出行业标准的需要.
主要方法:
- 七个DTC肠道微生物组测试服务的绩效评估.
- 利用由NIST开发的标准化人类便材料.
- 评估分析有效性和方法变化.
主要成果:
- 在不同DTC微生物组测试提供商内部和之间观察到的主要差异.
- 提供者之间的变异性与捐赠者之间的生物变异性相当.
- 确定了方法变化和质量控制不足作为关键问题.
结论:
- 分析性能对于可靠的临床建议至关重要.
- 目前的DTC微生物组测试显示出显著的变异性,影响了消费者的信心.
- 在微生物组测试行业中,有必要制定标准,以确保分析有效性和消费者安全.
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