Department of Clinical Laboratory Sciences, Faculty of Health Sciences, Yamaguchi University Graduate School of Medicine, Minami-Kogushi 1-1-1, Ube, 755-8505 Japan.
Clin Chem Lab Med. 2013 Jul;51(7):1429-42. doi: 10.1515/cclm-2012-0421.
A multicenter study conducted in Southeast Asia to derive reference intervals (RIs) for 72 commonly measured analytes (general chemistry, inflammatory markers, hormones, etc.) featured centralized measurement to clearly detect regionality in test results. The results of 31 standardized analytes are reported, with the remaining analytes presented in the next report.
The study included 63 clinical laboratories from South Korea, China, Vietnam, Malaysia, Indonesia, and seven areas in Japan. A total of 3541 healthy individuals aged 20-65 years (Japan 2082, others 1459) were recruited mostly from hospital workers using a well-defined common protocol. All serum specimens were transported to Tokyo at -80°C and collectively measured using reagents from four manufacturers. Three-level nested ANOVA was used to quantitate variation (SD) of test results due to region, sex, and age. A ratio of SD for a given factor over residual SD (representing net between-individual variations) (SDR) exceeding 0.3 was considered significant. Traceability of RIs was ensured by recalibration using value-assigned reference materials. RIs were derived parametrically.
SDRs for sex and age were significant for 19 and 16 analytes, respectively. Regional difference was significant for 11 analytes, including high density lipoprotein (HDL)-cholesterol and inflammatory markers. However, when the data were limited to those from Japan, regionality was not observed in any of the analytes. Accordingly, RIs were derived with or without partition by sex and region.
RIs applicable to a wide area in Asia were established for the majority of analytes with traceability to reference measuring systems, whereas regional partitioning was required for RIs of the other analytes.
在东南亚进行的一项多中心研究旨在为 72 种常见分析物（一般化学物质、炎症标志物、激素等）得出参考区间（RI），该研究采用集中测量方法，以清楚地检测测试结果的地域性。目前报告了 31 种标准化分析物的结果，其余分析物将在下一篇报告中呈现。
该研究包括来自韩国、中国、越南、马来西亚、印度尼西亚和日本七个地区的 63 家临床实验室。共有 3541 名年龄在 20-65 岁的健康个体（日本 2082 人，其他地区 1459 人）通过明确的通用方案主要从医院工作人员中招募。所有血清标本均在-80°C 下运至东京，并使用来自四个制造商的试剂进行集中测量。使用三级嵌套方差分析来量化因地区、性别和年龄导致的测试结果变异（SD）。如果给定因素的 SD 与残差 SD 的比值（代表个体间净变异）（SDR）超过 0.3，则认为该因素具有显著性。通过使用赋值参考物质进行重新校准来确保 RI 的溯源性。RI 采用参数法得出。
性别和年龄的 SDR 分别对 19 和 16 种分析物具有显著性。11 种分析物存在区域差异，包括高密度脂蛋白（HDL）-胆固醇和炎症标志物。然而，当将数据仅限于来自日本的数据时，在任何分析物中都没有观察到区域差异。因此，无论是否按性别和地区进行分区，都为大多数分析物得出了 RI。
为大多数分析物建立了具有可追溯性的参考测量系统的适用于亚洲广泛地区的 RI，而其他分析物的 RI 需要分区。
