Protocol and standard operating procedures for common use in a worldwide multicenter study on reference values

被引:89
作者
Ozarda, Yesim [2 ]
Ichihara, Kiyoshi [1 ]
Barth, Julian H. [3 ]
Klee, George [4 ]
机构
[1] Yamaguchi Univ, Fac Hlth Sci, Grad Sch Med, Dept Clin Lab Sci, Ube, Yamaguchi 7558505, Japan
[2] Uludag Univ Med, Sch Med, Dept Biochem & Clin Biochem, Bursa, Turkey
[3] Leeds Gen Infirm, Leeds, W Yorkshire, England
[4] Mayo Clin, Coll Med, Rochester, MN USA
基金
日本学术振兴会;
关键词
cross-check study; harmonization; multicenter study; panel of sera; reference interval; standardization; APPROVED RECOMMENDATION 1987; COLLECTED REFERENCE VALUES; REFERENCE INTERVALS; STATISTICAL TREATMENT; SERUM; TUBES; INDIVIDUALS; SPECIMENS; PROPOSAL;
D O I
10.1515/cclm-2013-0249
中图分类号
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号
1001 ;
摘要
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.
引用
收藏
页码:1027 / 1040
页数:14
相关论文
共 28 条
  • [1] [Anonymous], 1992, CLIN CHEM, V38, P1474
  • [2] Comparison of BD Vacutainer SST™ Plus Tubes with BD SST™ II Plus Tubes for common analytes
    Bush, VJ
    Janu, MR
    Bathur, F
    Wells, A
    Dasgupta, A
    [J]. CLINICA CHIMICA ACTA, 2001, 306 (1-2) : 139 - 143
  • [3] Ceriotti Ferruccio, 2007, Clin Biochem Rev, V28, P115
  • [4] Common reference intervals for aspartate aminotransferase (AST), alanine aminotransferase (ALT) and γ-glutamyl transferase (GGT) in serum: results from an IFCC multicenter study
    Ceriotti, Ferruccio
    Henny, Joseph
    Queralto, Josep
    Ziyu, Shen
    Ozarda, Yesim
    Chen, Baorong
    Boyd, James C.
    Panteghini, Mauro
    [J]. CLINICAL CHEMISTRY AND LABORATORY MEDICINE, 2010, 48 (11) : 1593 - 1601
  • [5] Common reference intervals: The IFCC position
    Ceriotti, Ferruccio
    [J]. CLINICAL BIOCHEMISTRY, 2009, 42 (4-5) : 297 - 297
  • [6] Clinical and Laboratory Standards Institute (CLSI), 2008, document EP28-A3c, Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory
  • [7] Approved Guideline, Vthird
  • [8] DYBKAER R, 1987, CLIN CHIM ACTA, V170, pS33, DOI 10.1016/0009-8981(87)90152-5
  • [9] Guideline for the production of multicentre physiological reference values using the same measurement system.: A proposal of the Catalan Association for Clinical Laboratory Sciences
    Fuentes-Arderiu, X
    Mas-Serra, R
    Alumà-Trullàs, A
    Martí-Marcet, MI
    Dot-Bach, D
    [J]. CLINICAL CHEMISTRY AND LABORATORY MEDICINE, 2004, 42 (07) : 778 - 782
  • [10] Multicentric reference values for some quantities measured with the Elecsys 2010® analyser
    Fuentes-Arderiu, X
    Ferrer-Masferrer, M
    González-Alba, JM
    Villarino-González, MI
    Arrimadas-Esteban, E
    Cabrero-Olivé, D
    Cándenas-Arroyo, M
    García-García, D
    García-Lario, JV
    Idoate-Cervantes, I
    León-López, C
    López-Lazareno, N
    Mar-Medina, C
    Martí-Marcet, I
    Mauri-Dot, M
    Pérez-Valero, V
    Reta-Manterola, A
    Sánchez-Eixeres, MR
    [J]. CLINICA CHIMICA ACTA, 2001, 304 (1-2) : 143 - 146