Katsuyuki Shinohara1, Naotaka Hamasaki2, Yasushi Takagi3, Yutaka Yatomi4, Hiroshi Kikuchi5, Shigemi Hosogaya6, Yohko Kawai7, Hayato Miyachi8, Kenji Kaneko9, Yoshifumi Miyajima9, Hiroyuki Matsumoto10, Yoshikazu Yamamoto11, Miyuki Iwagami9, Susumu Osawa9, Mamoru Umeda12, Hirofumi Koide12, Daisuke Yoshimura13, Hideo Kato14. 1. Department of Clinical Laboratory Medicine, Fukuoka University Chikushi Hospital, Chikushino, Japan; 2. 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. 3. Department of Medical Sciences Medical Education, Faculty of Medicine, Showa University, Tokyo, Japan; 4. Department of Clinical Laboratory Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; 5. Japan Association of Clinical Reagents Industries, Tokyo, Japan; 6. Department of Medical Technology, Faculty of Health Sciences, Tokyo University of Technology, Tokyo, Japan; 7. Department of Clinical Research Center, International University of Health and Welfare, Tokyo, Japan; 8. Department of Laboratory Medicine, Tokai University School of Medicine, Isehara, Japan; 9. The Japanese Association of Medical Technologists, Tokyo, Japan; 10. Clinical Laboratory, Nagoya University Hospital, Nagoya, Japan; 11. Department of Clinical Laboratory Science, Tenri Health Care University Division, Nara, Japan; 12. Japanese Committee for Clinical Laboratory Standards, Tokyo, Japan; 13. International Standardization Division, the Ministry of Economy, Trade and Industry, Tokyo, Japan. 14. Japanese Committee for Clinical Laboratory Standards, Tokyo, Japan; naotaka.hamasaki@city.sasebo.lg.jp hideokato@jccls.org.
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.
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: Uliana Danilenko; Hubert W Vesper; Gary L Myers; Patric A Clapshaw; Johanna E Camara; W Greg Miller Journal: Clin Chem Lab Med Date: 2020-02-25 Impact factor: 8.490