title: Multianalyte Conventional Reference Material (MacRM): A Useful Tool for Nationwide Standardization of Laboratory Measurements for Medical Care-A Model Study in Japan.
abstract: BACKGROUND
  The Japanese Committee for Clinical Laboratory Standards (JCCLS) has developed a multianalyte conventional reference material (MacRM) for nationwide standardization of laboratory measurements.
  
  
  METHODS
  To prepare the MacRM, pooled sera were obtained from healthy Japanese individuals. Target values of the pooled sera for 30 analytes were assigned on the basis of the measurement results of 45 certified clinical laboratories whose calibration was verified by measuring certified reference materials (CRMs) provided by the National Institute of Standards and Technology, the Institute for Reference Materials and Measurements, and JCCLS. Commutability of MacRM was assessed by comparison with results for 150 individual inpatients at Fukuoka University Chikushi Hospital. Survey samples were prepared by essentially the same method for MacRM but without target values. The survey samples were used to assess agreement among 165 laboratories that used various assay kits and platforms calibrated with the MacRM.
  
  
  RESULTS
  The commutability of MacRM was confirmed for 30 analytes with sera from 150 individual patients. The imprecision (CV) of measurements of survey samples (high and low concentrations) among the 165 laboratories was 0.4%-10.0%. Twenty-six of 30 analytes were within the goals for interinstitutional allowable bias. An aliquot of MacRM stored frozen at -80 °C remained stable for ≥4 years.
  
  
  CONCLUSIONS
  The MacRM was successfully applied as a calibrator to achieve nationwide standardization for 30 analytes measured by 165 laboratories that used various methods from different manufacturers.
authors.affiliation: Department of Clinical Laboratory Medicine, Fukuoka University Chikushi Hospital, Chikushino, Japan;
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Shinohara
authors.affiliation: Department of Clinical Chemistry, Faculty of Pharmaceutical Sciences, Nagasaki International University, Sasebo, Japan; Sasebo City Public Health Center, Sasebo, Japan; naotaka.hamasaki@city.sasebo.lg.jp hideokato@jccls.org.
authors.forename: Naotaka
authors.initials: N
authors.lastname: Hamasaki
authors.affiliation: Department of Medical Sciences Medical Education, Faculty of Medicine, Showa University, Tokyo, Japan;
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Takagi
authors.affiliation: Department of Clinical Laboratory Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan;
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Yatomi
authors.affiliation: Japan Association of Clinical Reagents Industries, Tokyo, Japan;
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kikuchi
authors.affiliation: Department of Medical Technology, Faculty of Health Sciences, Tokyo University of Technology, Tokyo, Japan;
authors.forename: Shigemi
authors.initials: S
authors.lastname: Hosogaya
authors.affiliation: Department of Clinical Research Center, International University of Health and Welfare, Tokyo, Japan;
authors.forename: Yohko
authors.initials: Y
authors.lastname: Kawai
authors.affiliation: Department of Laboratory Medicine, Tokai University School of Medicine, Isehara, Japan;
authors.forename: Hayato
authors.initials: H
authors.lastname: Miyachi
authors.affiliation: The Japanese Association of Medical Technologists, Tokyo, Japan;
authors.forename: Kenji
authors.initials: K
authors.lastname: Kaneko
authors.affiliation: The Japanese Association of Medical Technologists, Tokyo, Japan;
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Miyajima
authors.affiliation: Clinical Laboratory, Nagoya University Hospital, Nagoya, Japan;
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Matsumoto
authors.affiliation: Department of Clinical Laboratory Science, Tenri Health Care University Division, Nara, Japan;
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Yamamoto
authors.affiliation: The Japanese Association of Medical Technologists, Tokyo, Japan;
authors.forename: Miyuki
authors.initials: M
authors.lastname: Iwagami
authors.affiliation: The Japanese Association of Medical Technologists, Tokyo, Japan;
authors.forename: Susumu
authors.initials: S
authors.lastname: Osawa
authors.affiliation: Japanese Committee for Clinical Laboratory Standards, Tokyo, Japan;
authors.forename: Mamoru
authors.initials: M
authors.lastname: Umeda
authors.affiliation: Japanese Committee for Clinical Laboratory Standards, Tokyo, Japan;
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Koide
authors.affiliation: International Standardization Division, the Ministry of Economy, Trade and Industry, Tokyo, Japan.
authors.forename: Daisuke
authors.initials: D
authors.lastname: Yoshimura
authors.affiliation: Japanese Committee for Clinical Laboratory Standards, Tokyo, Japan; naotaka.hamasaki@city.sasebo.lg.jp hideokato@jccls.org.
authors.forename: Hideo
authors.initials: H
authors.lastname: Kato
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001774:Blood Chemical Analysis / Q000592:standards*; D019411:Clinical Laboratory Techniques / Q000592:standards*; D005260:Female; D005615:Freezing; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D012015:Reference Standards; D055815:Young Adult