臨床検査64巻11号

2020年11月発行

記事購入ページに移動

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．

参考文献

1）Sunderman FW Jr：Current concepts of “normal values,” “reference values,” and “discrimination values,” in clinical chemistry. Clin Chem　21：1873-1877，1975

2）Solberg HE. International Federation of Clinical Chemistry (IFCC)：Approved recommendation (1987) on the theory of reference values. Part 5. Statistical treatment of collected reference values. Determination of reference limits. Clin Chim Acta　170：S13-S32，1987

3）Clinical and Laboratory Standards Institute (CLSI)：Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline, 3rd ed. CLSI document C28-A3, CLSI, Wayne PA，2008

4）Ichihara K, Kawai T：Determination of reference intervals for 13 plasma proteins based on IFCC international reference preparation (CRM470) and NCCLS proposed guideline (C28-P, 1992): trial to select reference individuals by results of screening tests and application of maximal likelihood method. J Clin Lab Anal　10：110-117，1996

5）Ichihara K, Kawai T：Determination of reference intervals for 13 plasma proteins based on IFCC international reference preparation (CRM470) and NCCLS proposed guideline (C28-P, 1992): a strategy for partitioning reference individuals with validation based on multivariate analysis. J Clin Lab Anal　11：117-124，1997

6）Ichihara K, Itoh Y, Min WK, et al：Diagnostic and epidemiological implications of regional differences in serum concentrations of proteins observed in six Asian cities. Clin Chem Lab Med　42：800-809，2004

7）Johnson AM, Whicher JT：Effect of certified reference material 470 (CRM 470) on national quality assurance programs for serum proteins in Europe. Clin Chem Lab Med　39：1123-1128，2001

8）Ichihara K, Itoh Y, Lam CW, et al：Sources of variation of commonly measured serum analytes in 6 Asian cities and consideration of common reference intervals. Clin Chem　54：356-365，2008

9）Rustad P, Felding P, Franzson L, et al：The Nordic Reference Interval Project 2000: recommended reference intervals for 25 common biochemical properties. Scand J Clin Lab Invest　64：271-284，2004

10）Ichihara K, Ceriotti F, Tam TH, et al：The Asian project for collaborative derivation of reference intervals: (1) strategy and major results of standardized analytes. Clin Chem Lab Med　51：1429-1442，2013

11）Ichihara K, Boyd JC, IFCC Committee on Reference Intervals and Decision Limits (C-RIDL)：An appraisal of statistical procedures used in derivation of reference intervals. Clin Chem Lab Med　48：1537-1551，2010

12）Ichihara K, Ozarda Y, Klee G, et al：Utility of a panel of sera for the alignment of test results in the worldwide multicenter study on reference values. Clin Chem Lab Med　51：1007-1025，2013

13）Ozarda Y, Ichihara K, Barth JH, et al：Protocol and standard operating procedures for common use in a worldwide multicenter study on reference values. Clin Chem Lab Med　51：1027-1040，2013

14）Ichihara K, Ozarda Y, Barth JH, et al：A global multicenter study on reference values: 1. Assessment of methods for derivation and comparison of reference intervals. Clin Chim Acta　467：70-82，2017

15）Ichihara K, Ozarda Y, Barth JH, et al：A global multicenter study on reference values: 2. Exploration of sources of variation across the countries. Clin Chim Acta　467：83-97，2017

16）Ichihara K, Yomamoto Y, Hotta T, et al：Collaborative derivation of reference intervals for major clinical laboratory tests in Japan. Ann Clin Biochem 53(Pt 3)：347-356，2016

17）Borai A, Ichihara K, Masaud A, et al：Establishment of reference intervals for immunoassay analytes of adult population in Saudi Arabia. Clin Chem Lab Med　58：1302-1313，2020

18）Bawua ASA, Ichihara K, Keatley R, et al：Establishing Ghanaian adult reference intervals for hematological parameters controlling for latent anemia and inflammation. Int J Lab Hematol, 2020, in press

19）小児基準値研究班（編）：日本人小児の臨床検査基準値，日本公衆衛生協会，1996

20）Colantonio DA, Kyriakopoulou L, Chan MK, et al：Closing the gaps in pediatric laboratory reference intervals: a CALIPER database of 40 biochemical markers in a healthy and multiethnic population of children. Clin Chem　58：854-868，2012

21）市原清志：臨床判断値の概念・用途，基準範囲との相違点．臨病理　66：884-890，2018

22）Yamakado M, Ichihara K, Matsumoto Y, et al：Derivation of gender and age-specific reference intervals from fully normal Japanese individuals and the implications for health screening. Clin Chim Acta　447：105-114，2015

23）Hoffmann RG：Statistics in the practice of medicine. JAMA　185：864-873，1963

24）Bhattacharya CG：A simple method of resolution of a distribution into gaussian components. Biometrics　23：115-135，1967

25）Tate JR, Sikaris KA, Jones GR, et al：Harmonising adult and paediatric reference intervals in australia and new zealand: an evidence-based approach for establishing a first panel of chemistry analytes. Clin Biochem Rev　35：213-235，2014

26）den Elzen WPJ, Brouwer N, Thelen MH, et al：NUMBER: standardized reference intervals in the Netherlands using a ‘big data’ approach. Clin Chem Lab Med　57：42-56，2018

27）Zierk J, Arzideh F, Rechenauer T, et al：Age- and sex-specific dynamics in 22 hematologic and biochemical analytes from birth to adolescence. Clin Chem　61：964-973，2015

28）西田敏信：臨床検査値の加齢変化．臨検　45：353-358，2001

29）田中敏章，山下敦，市原清志：潜在基準値抽出法による小児臨床検査基準範囲の設定．日本小児科学会雑誌　112：1117-1132，2008