A global multicenter study on reference values

1. Assessment of methods for derivation and comparison of reference intervals

Kiyoshi Ichihara, Yesim Ozarda, Julian H. Barth, George Klee, Ling Qiu, Rajiv Erasmus, Anwar Borai, Svetlana Evgina, Tester Ashavaid, Dilshad Khan, Laura Schreier, Reynan Rolle, Yoshihisa Shimizu, Shogo Kimura, Reo Kawano, David Armbruster, Kazuo Mori, Binod K. Yadav

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

Objectives: The IFCC Committee on Reference Intervals and Decision Limits coordinated a global multicenter study on reference values (RVs) to explore rational and harmonizable procedures for derivation of reference intervals (RIs) and investigate the feasibility of sharing RIs through evaluation of sources of variation of RVs on a global scale. Methods: For the common protocol, rather lenient criteria for reference individuals were adopted to facilitate harmonized recruitment with planned use of the latent abnormal values exclusion (LAVE) method. As of July 2015, 12 countries had completed their study with total recruitment of 13,386 healthy adults. 25 analytes were measured chemically and 25 immunologically. A serum panel with assigned values was measured by all laboratories. RIs were derived by parametric and nonparametric methods. Results: The effect of LAVE methods is prominent in analytes which reflect nutritional status, inflammation and muscular exertion, indicating that inappropriate results are frequent in any country. The validity of the parametric method was confirmed by the presence of analyte-specific distribution patterns and successful Gaussian transformation using the modified Box-Cox formula in all countries. After successful alignment of RVs based on the panel test results, nearly half the analytes showed variable degrees of between-country differences. This finding, however, requires confirmation after adjusting for BMI and other sources of variation. The results are reported in the second part of this paper. Conclusion: The collaborative study enabled us to evaluate rational methods for deriving RIs and comparing the RVs based on real-world datasets obtained in a harmonized manner.

Original languageEnglish (US)
JournalClinica Chimica Acta
Volume467
DOIs
StatePublished - Apr 1 2017

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Multicenter Studies
Reference Values
Nutritional Status
Inflammation
Serum

Keywords

  • Ethnic differences
  • Harmonization
  • Latent abnormal values exclusion method
  • Modified Box-Cox power transformation
  • Multicenter study
  • Reference intervals
  • Serum panel
  • Standard deviation ratio
  • Standardization

ASJC Scopus subject areas

  • Biochemistry
  • Clinical Biochemistry
  • Biochemistry, medical

Cite this

A global multicenter study on reference values : 1. Assessment of methods for derivation and comparison of reference intervals. / Ichihara, Kiyoshi; Ozarda, Yesim; Barth, Julian H.; Klee, George; Qiu, Ling; Erasmus, Rajiv; Borai, Anwar; Evgina, Svetlana; Ashavaid, Tester; Khan, Dilshad; Schreier, Laura; Rolle, Reynan; Shimizu, Yoshihisa; Kimura, Shogo; Kawano, Reo; Armbruster, David; Mori, Kazuo; Yadav, Binod K.

In: Clinica Chimica Acta, Vol. 467, 01.04.2017.

Research output: Contribution to journalArticle

Ichihara, K, Ozarda, Y, Barth, JH, Klee, G, Qiu, L, Erasmus, R, Borai, A, Evgina, S, Ashavaid, T, Khan, D, Schreier, L, Rolle, R, Shimizu, Y, Kimura, S, Kawano, R, Armbruster, D, Mori, K & Yadav, BK 2017, 'A global multicenter study on reference values: 1. Assessment of methods for derivation and comparison of reference intervals', Clinica Chimica Acta, vol. 467. https://doi.org/10.1016/j.cca.2016.09.016
Ichihara, Kiyoshi ; Ozarda, Yesim ; Barth, Julian H. ; Klee, George ; Qiu, Ling ; Erasmus, Rajiv ; Borai, Anwar ; Evgina, Svetlana ; Ashavaid, Tester ; Khan, Dilshad ; Schreier, Laura ; Rolle, Reynan ; Shimizu, Yoshihisa ; Kimura, Shogo ; Kawano, Reo ; Armbruster, David ; Mori, Kazuo ; Yadav, Binod K. / A global multicenter study on reference values : 1. Assessment of methods for derivation and comparison of reference intervals. In: Clinica Chimica Acta. 2017 ; Vol. 467.
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abstract = "Objectives: The IFCC Committee on Reference Intervals and Decision Limits coordinated a global multicenter study on reference values (RVs) to explore rational and harmonizable procedures for derivation of reference intervals (RIs) and investigate the feasibility of sharing RIs through evaluation of sources of variation of RVs on a global scale. Methods: For the common protocol, rather lenient criteria for reference individuals were adopted to facilitate harmonized recruitment with planned use of the latent abnormal values exclusion (LAVE) method. As of July 2015, 12 countries had completed their study with total recruitment of 13,386 healthy adults. 25 analytes were measured chemically and 25 immunologically. A serum panel with assigned values was measured by all laboratories. RIs were derived by parametric and nonparametric methods. Results: The effect of LAVE methods is prominent in analytes which reflect nutritional status, inflammation and muscular exertion, indicating that inappropriate results are frequent in any country. The validity of the parametric method was confirmed by the presence of analyte-specific distribution patterns and successful Gaussian transformation using the modified Box-Cox formula in all countries. After successful alignment of RVs based on the panel test results, nearly half the analytes showed variable degrees of between-country differences. This finding, however, requires confirmation after adjusting for BMI and other sources of variation. The results are reported in the second part of this paper. Conclusion: The collaborative study enabled us to evaluate rational methods for deriving RIs and comparing the RVs based on real-world datasets obtained in a harmonized manner.",
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AU - Ichihara, Kiyoshi

AU - Ozarda, Yesim

AU - Barth, Julian H.

AU - Klee, George

AU - Qiu, Ling

AU - Erasmus, Rajiv

AU - Borai, Anwar

AU - Evgina, Svetlana

AU - Ashavaid, Tester

AU - Khan, Dilshad

AU - Schreier, Laura

AU - Rolle, Reynan

AU - Shimizu, Yoshihisa

AU - Kimura, Shogo

AU - Kawano, Reo

AU - Armbruster, David

AU - Mori, Kazuo

AU - Yadav, Binod K.

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N2 - Objectives: The IFCC Committee on Reference Intervals and Decision Limits coordinated a global multicenter study on reference values (RVs) to explore rational and harmonizable procedures for derivation of reference intervals (RIs) and investigate the feasibility of sharing RIs through evaluation of sources of variation of RVs on a global scale. Methods: For the common protocol, rather lenient criteria for reference individuals were adopted to facilitate harmonized recruitment with planned use of the latent abnormal values exclusion (LAVE) method. As of July 2015, 12 countries had completed their study with total recruitment of 13,386 healthy adults. 25 analytes were measured chemically and 25 immunologically. A serum panel with assigned values was measured by all laboratories. RIs were derived by parametric and nonparametric methods. Results: The effect of LAVE methods is prominent in analytes which reflect nutritional status, inflammation and muscular exertion, indicating that inappropriate results are frequent in any country. The validity of the parametric method was confirmed by the presence of analyte-specific distribution patterns and successful Gaussian transformation using the modified Box-Cox formula in all countries. After successful alignment of RVs based on the panel test results, nearly half the analytes showed variable degrees of between-country differences. This finding, however, requires confirmation after adjusting for BMI and other sources of variation. The results are reported in the second part of this paper. Conclusion: The collaborative study enabled us to evaluate rational methods for deriving RIs and comparing the RVs based on real-world datasets obtained in a harmonized manner.

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