Department of Biochemistry and Clinical Biochemistry, Uludag University Medical School of Medicine, Bursa, Turkey.
Clin Chem Lab Med. 2013 May;51(5):1027-40. doi: 10.1515/cclm-2013-0249.
The reference intervals (RIs) given in laboratory reports have an important role in aiding clinicians in interpreting test results in reference to values of healthy populations. In this report, we present a proposed protocol and standard operating procedures (SOPs) for common use in conducting multicenter RI studies on a national or international scale. The protocols and consensus on their contents were refined through discussions in recent C-RIDL meetings. The protocol describes in detail (1) the scheme and organization of the study, (2) the target population, inclusion/exclusion criteria, ethnicity, and sample size, (3) health status questionnaire, (4) target analytes, (5) blood collection, (6) sample processing and storage, (7) assays, (8) cross-check testing, (9) ethics, (10) data analyses, and (11) reporting of results. In addition, the protocol proposes the common measurement of a panel of sera when no standard materials exist for harmonization of test results. It also describes the requirements of the central laboratory, including the method of cross-check testing between the central laboratory of each country and local laboratories. This protocol and the SOPs remain largely exploratory and may require a reevaluation from the practical point of view after their implementation in the ongoing worldwide study. The paper is mainly intended to be a basis for discussion in the scientific community.
实验室报告中的参考区间（RIs）在帮助临床医生参照健康人群的值来解释检验结果方面起着重要作用。在本报告中，我们提出了一个用于在国家或国际范围内进行多中心 RI 研究的建议方案和标准操作程序（SOPs）。这些方案和其内容的共识是通过最近的 C-RIDL 会议上的讨论而细化的。该方案详细描述了（1）研究的方案和组织，（2）目标人群、纳入/排除标准、种族和样本量，（3）健康状况问卷，（4）目标分析物，（5）血液采集，（6）样本处理和储存，（7）检测，（8）交叉检查测试，（9）伦理，（10）数据分析，以及（11）结果报告。此外，该方案提出了在没有标准物质用于统一检验结果时共同测量一组血清的建议。它还描述了中心实验室的要求，包括每个国家的中心实验室与当地实验室之间交叉检查测试的方法。该方案和 SOPs 在很大程度上仍然是探索性的，并且在正在进行的全球研究中实施后可能需要从实际角度进行重新评估。本文主要旨在为科学界的讨论提供基础。
