臨床検査64巻11号

2020年11月発行

今月の特集1 基準範囲と臨床判断値を考える

—基準範囲の調和化・共用化—基準範囲設定の調和化—世界の現状

著者： 市原清志¹

所属機関： ¹山口大学大学院医学系研究科保健学専攻・生体情報検査学

ページ範囲：P.1276 - P.1285

Point

●基準範囲（RI）の概念と設定にかかわる国際的な議論は，国際臨床化学連合（IFCC）で1978年に始まり，1995年にIFCCと米国臨床検査標準委員会（NCCLS）が協議し基準範囲設定指針を発刊した．

●2000年以降，主要検査の標準化の達成により，共用基準範囲設定を目指した国際調査が北欧やアジアで始まった．

●2005年，IFCCに基準範囲判断値委員会（C-RIDL）が設置され，2012年から基準範囲設定の普及と基準値の国際比較を目指した世界調査を開始し，19カ国が参加した．

●世界調査の中間解析から，多数検査で国間差の存在が判明し，RIの地域や国単位での設定の必要性が示された．

●健常者を募る直接法による設定の困難さから，臨床検査情報システム（LIS）を利用する間接法への期待が最近高まり，現在C-RIDLで，その方法論の比較検証・改良が試みられている．

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