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International collaboration toward establishment of reference value database for common use in evidence-based laboratory diagnosis

Research Project

Project/Area Number 24256003
Research Category

Grant-in-Aid for Scientific Research (A)

Allocation TypeSingle-year Grants
Section海外学術
Research Field Laboratory medicine
Research InstitutionYamaguchi University

Principal Investigator

ICHIHARA Kiyoshi  山口大学, 医学(系)研究科(研究院), 教授 (10144495)

Co-Investigator(Kenkyū-buntansha) NOJIMA Junzo  山口大学, 大学院医学系研究科, 教授 (30448071)
SHIMIZU Yoshihisa  山口大学, 大学院医学系研究科, 助教 (80403674)
Research Collaborator GUO Jian  Beijing Hospital, Dr
QIU Ling  Beijing Union Medical College, Dr
XIA Liangyu  Beijing Union Hospital, Dr
ROLLE Reynan  Univ of San Agustin
RAJA Elina  Hospital Kuala Lumpur, Dr
ASHAVAID Tester  P.D. Hinduja National Hospital Medical Research Center, Dr
SHAH Swarup  P.D. Hinduja National Hospital Medical Research Center, Dr
YADAV Binod  Institute of Medicine Teaching Hospital
AHMED Firoz  International Center for Diarrheal Disease Research, Dr
KUMKUM Asifa  International Center for Diarrheal Disease Research
HOSSAIN Anowar  International Center for Diarrheal Disease Research, Dr
GHANI Farooq  Aga Kahn Univ, Dr
JAFRI Lena  Aga Kahn Univ, Dr
KHAN Dilshad  Armed Force Institute of Pathology, Prof.
BORAI Anwar  King Khalid National Guard Hospital, Dr
ÖZARDA Yeşim  Uludag Univ, Prof.
EVGINA Svtlana  Beckman Coulter Russia, Dr
RUZHANSKAYA Anna  Beckman Coulter Russia, Dr
BARTH Julian  Leeds Infirmary, Dr
SCHUMANN Gerhard  Univ of Hannover, Prof
SIEKMAN Lothar  Bonn Medical Univ, Prof
KESSLER Anja  Bonn Medical Univ, Dr
NORDESTGAARD Børge  Copenhagen Univ, Prof
ERASMUS Rajiv  Univ of Stellenbosch, Prof.
HOFFMANN Mariza  Univ of Stellenbosch, Dr
SMIT Francoise  Cape Peninsula Univ of Technology
OMUSE Geoffrey  Aga Khan Univ Hospital Nairobi, Dr
ELGADAR Ola  Univ Alexandria, Dr
BAZ Heba  Univ Cairo, Dr
MARCI Joseph  Hamilton General Hospital, Dr.
KLEE George  Mayo Clinic, Prof.
STRASESKI Joely  Univ of Utah, Dr
STANHOPE Kimber  Univ of California Davis, Dr
SCHREIER Laura  Univ of Buenos Aires, Prof.
BUSTOS Daniel N  Univ of Buenos Aires, Dr
Project Period (FY) 2012-04-01 – 2015-03-31
Project Status Completed (Fiscal Year 2014)
Budget Amount *help
¥42,900,000 (Direct Cost: ¥33,000,000、Indirect Cost: ¥9,900,000)
Fiscal Year 2014: ¥7,930,000 (Direct Cost: ¥6,100,000、Indirect Cost: ¥1,830,000)
Fiscal Year 2013: ¥15,730,000 (Direct Cost: ¥12,100,000、Indirect Cost: ¥3,630,000)
Fiscal Year 2012: ¥19,240,000 (Direct Cost: ¥14,800,000、Indirect Cost: ¥4,440,000)
Keywords基準範囲 / EBLM / 標準化 / 生理的変動要因 / 多施設共同調査 / 国際臨床化学連合 / パネル血清 / 国際比較調査 / 調和化 / 臨床検査変動要因 / 国際調査 / 地域差
Outline of Final Research Achievements

The methodologies for derivation of reference intervals (RIs) of clinical laboratory tests remain controversial. This investigator launched an international collaborative multicenter study on reference values (RVs) as a project of Committee on Reference Intervals and Decision Limits of International Federation of Clinical Chemistry. Its aims are 1) elaboration of internationally sharable protocol for conducting RI study, 2) establishing optimal statistical methods for derivation of RIs, 3) ensuring standardization of derived RIs, and 4) exploration of sources of variation (SV) of RVs. By March 2015, 16 countries from 5 continents collaborated and RIs of 10 countries have been derived so far by new reliable methods. The reference values of each country were gathered and dynamically aligned to each other based on test results of the serum panel measured in common. A variety of SV of RVs have been revealed, which are all relevant for the practice of evidence-based laboratory diagnosis.

Report

(4 results)
  • 2014 Annual Research Report   Final Research Report ( PDF )
  • 2013 Annual Research Report
  • 2012 Annual Research Report
  • Research Products

    (23 results)

All 2015 2014 2013 Other

All Journal Article (11 results) (of which Peer Reviewed: 11 results,  Acknowledgement Compliant: 5 results,  Open Access: 2 results) Presentation (12 results) (of which Invited: 11 results)

  • [Journal Article] Sources of variation analysis and derivation of reference intervals for ALP, LDH, and amylase isozymes using sera from the Asian multicenter study on reference values.2015

    • Author(s)
      Shimizu Y, Ichihara K
    • Journal Title

      Clin Chim Acta

      Volume: 446 Pages: 64-72

    • DOI

      10.1016/j.cca.2015.03.034

    • Related Report
      2014 Annual Research Report
    • Peer Reviewed / Open Access / Acknowledgement Compliant
  • [Journal Article] Derivation of gender and age-specific reference intervals from fully normal Japanese individuals and the implications for health screening.2015

    • Author(s)
      Yamakado M. Ichihara K. Matsumoto Y, Ishikawa Y, Kato K, Komatsubara Y, Takaya N, Tomita S, Kawano K, Takada K, Watanabe K.
    • Journal Title

      Clin Chim Acta

      Volume: 446 Pages: 105-114

    • DOI

      10.1016/j.cca.2015.04.037

    • Related Report
      2014 Annual Research Report
    • Peer Reviewed / Open Access
  • [Journal Article] A multicenter nationwide reference intervals study for common biochemical analytes in Turkey using Abbott analyzers.2014

    • Author(s)
      Ozarda Y, Ichihara K, Aslan D, Ilhan N, Sadak-Atali D, Bakan E, Polat H, Noyan T, Can M, Bedir A, Okuyucu A, Deger O, Agac S, Ademoglu E, Kaya A, Nogay T, Eren N, Dirican M, Tuncer GO, Aykus M, Gunes Y, Ozmen SU, Kawano R, Tezcan S, Demirpence O, Degirmen E.
    • Journal Title

      Clin Chem Lab Med

      Volume: 52 Issue: 12 Pages: 1823-1833

    • DOI

      10.1515/cclm-2014-0228

    • Related Report
      2014 Annual Research Report
    • Peer Reviewed / Acknowledgement Compliant
  • [Journal Article] Call for the use of a common equation for glomerular filtration rate estimation in East and South-east Asia.2014

    • Author(s)
      Wang X, Ichihara K, Xu G, Itoh Y
    • Journal Title

      Clin Biochem

      Volume: 47 Issue: 13-14 Pages: 1214-1219

    • DOI

      10.1016/j.clinbiochem.2014.05.058

    • Related Report
      2014 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Statistical considerations for harmonization of the global multicenter study on reference values.2014

    • Author(s)
      Ichihara K
    • Journal Title

      Clin Chim Acta

      Volume: 432 Pages: 1823-1833

    • DOI

      10.1016/j.cca.2014.01.025

    • Related Report
      2013 Annual Research Report
    • Peer Reviewed / Acknowledgement Compliant
  • [Journal Article] The Asian project for collaborative derivation of reference intervals: (1) strategy and major results of standardized analytes.2013

    • Author(s)
      Ichihara K, Ceriotti F, Tam TH, Sueyoshi S, Poon PMK, Thong ML, Higashiuesato Y, Wang X, Kataoka H, Matsubara A, Shiesh S, Muliaty D, Kim J, Watanabe M, Siekmann L, Lopez JB, Panteghini M.
    • Journal Title

      Clin Chem Lab Med

      Volume: 51 Issue: 7 Pages: 1429-1442

    • DOI

      10.1515/cclm-2012-0421

    • NAID

      120005568043

    • Related Report
      2013 Annual Research Report 2012 Annual Research Report
    • Peer Reviewed / Acknowledgement Compliant
  • [Journal Article] The Asian project for collaborative derivation of reference intervals: (2) results of non-standardized analytes and transference of reference intervals to the participating laboratories on the basis of cross-comparison of test results.2013

    • Author(s)
      Ichihara K, Ceriotti F, Mori K, Huang Y, Shimizu Y, Suzuki H, Kitagawa M, Yamauchi K, Hayashi S, Tsou C, Yamamoto Y, Ishida S, Leong L, Sano M, Sub H, Suwabe A, Woo H, Kojima K, Okubo Y.
    • Journal Title

      Clin Chem Lab Med

      Volume: 51 Issue: 7 Pages: 1443-1457

    • DOI

      10.1515/cclm-2012-0422

    • NAID

      120005568042

    • Related Report
      2013 Annual Research Report 2012 Annual Research Report
    • Peer Reviewed / Acknowledgement Compliant
  • [Journal Article] Nationwide multicenter study aimed at the establishment of common reference intervals for standardized clinical laboratory tests in Japan.2013

    • Author(s)
      Yamamoto Y, Hosogaya S, Osawa S, Ichihara K, Onuma T, Saito A, Banba K, Araki H, Nagamine Y, Shinohara K, Okada G, Matsumoto H, Oguri T, Gonaikawa S, Iwagami M on behalf of the Japanese Association of Medical Technologists.
    • Journal Title

      Clin Chem Lab Med

      Volume: 51 Issue: 8 Pages: 663-667

    • DOI

      10.1515/cclm-2012-0413

    • Related Report
      2013 Annual Research Report 2012 Annual Research Report
    • Peer Reviewed
  • [Journal Article] The influence of non-specificity of the creatinine assay on eGFR2013

    • Author(s)
      Wang X, Ichihara K, Xu G, Itoh Y
    • Journal Title

      Clin Chem Lab Med

      Volume: 51 Issue: 10 Pages: e223-e224

    • DOI

      10.1515/cclm-2013-0289

    • Related Report
      2013 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Utility of a panel of sera for the alignment of test results in the worldwide multicenter study on reference values.2013

    • Author(s)
      Ichihara K
    • Journal Title

      Clin Chem Lab Med

      Volume: 51 Issue: 5 Pages: 1007-25

    • DOI

      10.1515/cclm-2013-0248

    • NAID

      120005615688

    • Related Report
      2012 Annual Research Report
    • Peer Reviewed
  • [Journal Article] Protocol and standard operating procedures for common use in the worldwide multicenter study on reference values.2013

    • Author(s)
      Ozarda Y
    • Journal Title

      Clin Chem Lab Med

      Volume: 51 Issue: 5 Pages: 1027-40

    • DOI

      10.1515/cclm-2013-0249

    • Related Report
      2012 Annual Research Report
    • Peer Reviewed
  • [Presentation] The IFCC global multicenter study on reference values: its objectives and current status.2014

    • Author(s)
      Ichihara K
    • Organizer
      All Russian Congress of Laboratory Medicine
    • Place of Presentation
      Moscow, Russia
    • Year and Date
      2014-10-01
    • Related Report
      2014 Annual Research Report
    • Invited
  • [Presentation] Biological variations: essential knowledge for the practice of EBLM.2014

    • Author(s)
      Ichihara K
    • Organizer
      The 11th Philippine Council for Quality Assurance of Clinical Laboratory
    • Place of Presentation
      Manila, Philippines
    • Year and Date
      2014-09-24
    • Related Report
      2014 Annual Research Report
    • Invited
  • [Presentation] Essential knowledge on biological sources of variation for the practice of EBLM.2014

    • Author(s)
      Ichihara K
    • Organizer
      MedLab Asia Pacific 2014 in Singapore
    • Place of Presentation
      Singapore, Singapore
    • Year and Date
      2014-02-18
    • Related Report
      2013 Annual Research Report
    • Invited
  • [Presentation] The global multicenter study on reference values and its strategy for harmonization of the results. 2) Essential statistical methods for analyzing sources of variations in laboratory tests.2013

    • Author(s)
      Ichihara K
    • Organizer
      The 13th Conference of Asian Network for Clinical Laboratory Standardization (ANCLS)
    • Place of Presentation
      Ho Chi Minh City, Vietnam
    • Year and Date
      2013-11-14
    • Related Report
      2013 Annual Research Report
    • Invited
  • [Presentation] he strategy and implication of the global study. Symposium: The IFCC global multicenter study on reference values: An Asian perspective.2013

    • Author(s)
      Ichihara K
    • Organizer
      The 13th Congress of Asia-Pacific Fed of Clin Biochem,
    • Place of Presentation
      Bali, Indonesia
    • Year and Date
      2013-10-29
    • Related Report
      2013 Annual Research Report
    • Invited
  • [Presentation] Establishing reference intervals is an imperative but challenging task. The XII National Congress of Biochemistry2013

    • Author(s)
      Ichihara K
    • Organizer
      The XII National Congress of Biochemistry
    • Place of Presentation
      Buenos Aires, Argentina
    • Year and Date
      2013-10-06
    • Related Report
      2013 Annual Research Report
    • Invited
  • [Presentation] Course on Multivariate Analysis for EBLM2013

    • Author(s)
      Ichihara K
    • Organizer
      Seminar for South African Association for Clinical Biochemistry,
    • Place of Presentation
      Cape Town, South Africa
    • Year and Date
      2013-07-31 – 2013-08-01
    • Related Report
      2013 Annual Research Report
    • Invited
  • [Presentation] The challenge and perspective of the on-going global study on reference values.2013

    • Author(s)
      Ichihara K
    • Organizer
      Laboratory Medicine Congress 2013
    • Place of Presentation
      Cape Town, South Africa
    • Year and Date
      2013-07-31
    • Related Report
      2013 Annual Research Report
    • Invited
  • [Presentation] The interim report on regionality of test results within Turkey with comparison of results across the countries.

    • Author(s)
      Ichihara K
    • Organizer
      The Istanbul Division Conference of the Turkish Biochemical Society (TBS)
    • Place of Presentation
      Istanbul, Turkey
    • Related Report
      2012 Annual Research Report
    • Invited
  • [Presentation] The Current Status of IFCC Global Study on Referance Values and Its Perspective.

    • Author(s)
      Ichihara K
    • Organizer
      The 26th Turkey National Congress on Biochemistry.
    • Place of Presentation
      Konya, Turkey
    • Related Report
      2012 Annual Research Report
    • Invited
  • [Presentation] IFCC global study on reference values: the strategy and perspective.

    • Author(s)
      Ichihara K
    • Organizer
      The Annual Congress of the South African Association of Clinical Biochemistry.
    • Place of Presentation
      Cape Town, South Africa
    • Related Report
      2012 Annual Research Report
    • Invited
  • [Presentation] What is an optimal protocol for the IFCC global study on reference values?

    • Author(s)
      Ichihara K
    • Organizer
      The 12th Asian Society of Clinical Pathology and Laboratory Medicine.
    • Place of Presentation
      Kyoto, Japan (国立京都国際会館)
    • Related Report
      2012 Annual Research Report

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Published: 2013-05-15   Modified: 2019-07-29  

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