title: Total cholesterol performance of Abell-Levy-Brodie-Kendall reference measurement procedure: Certification of Japanese in-vitro diagnostic assay manufacturers through CDC's Cholesterol Reference Method Laboratory Network.
abstract: BACKGROUND
  Accurate measurement of total cholesterol (TC) is important for cardiovascular disease risk management. The US Centers for Disease Control and Prevention (CDC) and Cholesterol Reference Method Laboratory Network (CRMLN) perform Abell-Levy-Brodie-Kendall (AK) reference measurement procedure (RMP) for TC as a secondary reference method, and implement Certification Protocol for Manufacturers. Japanese CRMLN laboratory at Osaka performed the AK RMP for 22 years, and conducted TC certification for reagent/calibrator/instrument systems of six Japanese manufacturers every 2 years for 16 years. Osaka TC performance was examined and compared to CDC's reference values.
  
  
  METHODS
  AK RMP involved sample hydrolysis, cholesterol extraction, and determination of cholesterol levels by spectrophotometry. The Certification Protocol for Manufacturers includes comparison with AK RMP using at least 40 fresh specimens. Demonstration of average bias ≤3% and total coefficient of variation ≤3% qualified an analytical system for certification.
  
  
  RESULTS
  In the AK RMP used in the Osaka CRMLN laboratory, the regression equation for measuring TC was y (Osaka)=1.000x (CDC)+0.032 (n=619, R(2)=1.000). Six Japanese manufacturers had allowable performance for certification.
  
  
  CONCLUSIONS
  The AK RMP for TC measurement was accurate, precise, and stable for 22 years. Six Japanese manufacturers were certified for 16 years.
authors.affiliation: National Cerebral and Cardiovascular Center, Department of Preventive Cardiology, Lipid Reference Laboratory, Japan. Electronic address: nakamura.masakazu.hp@ncvc.go.jp.
authors.forename: Masakazu
authors.initials: M
authors.lastname: Nakamura
authors.affiliation: Public Health, Department of Social Medicine, Graduate School of Medicine, Osaka University, Japan.
authors.forename: Hiroyasu
authors.initials: H
authors.lastname: Iso
authors.affiliation: Public Health, Department of Social Medicine, Graduate School of Medicine, Osaka University, Japan.
authors.forename: Akihiko
authors.initials: A
authors.lastname: Kitamura
authors.affiliation: Public Health, Department of Social Medicine, Graduate School of Medicine, Osaka University, Japan.
authors.forename: Hironori
authors.initials: H
authors.lastname: Imano
authors.affiliation: Osaka Center for Cancer and Cardiovascular Disease Prevention, Japan.
authors.forename: Masahiko
authors.initials: M
authors.lastname: Kiyama
authors.affiliation: Nutritional Health Science Research Center, Chubu University, Japan.
authors.forename: Shinji
authors.initials: S
authors.lastname: Yokoyama
authors.affiliation: Department of Health Sciences, Faculty of Medical Sciences, Kyushu University, Japan.
authors.forename: Yuzo
authors.initials: Y
authors.lastname: Kayamori
authors.affiliation: National Cerebral and Cardiovascular Center, Department of Preventive Cardiology, Lipid Reference Laboratory, Japan.
authors.forename: Isao
authors.initials: I
authors.lastname: Koyama
authors.affiliation: National Cerebral and Cardiovascular Center, Department of Preventive Medicine and Epidemiologic Informatics, Japan.
authors.forename: Kunihiro
authors.initials: K
authors.lastname: Nishimura
authors.affiliation: National Cerebral and Cardiovascular Center, Department of Preventive Medicine and Epidemiologic Informatics, Japan.
authors.forename: Michikazu
authors.initials: M
authors.lastname: Nakai
authors.affiliation: Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, USA.
authors.forename: Mahnaz
authors.initials: M
authors.lastname: Dasti
authors.affiliation: Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, USA.
authors.forename: Hubert W
authors.initials: HW
authors.lastname: Vesper
authors.affiliation: Teikyo Academic Research Center, Teikyo University, Japan.
authors.forename: Tamio
authors.initials: T
authors.lastname: Teramoto
authors.affiliation: National Cerebral and Cardiovascular Center, Department of Preventive Cardiology, Department of Preventive Medicine and Epidemiologic Informatics, Japan.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Miyamoto
mesh_terms: D001681:Biological Assay / Q000592:standards*; D002568:Certification; D002784:Cholesterol / Q000097:blood*; D006801:Humans; D007564:Japan; D007753:Laboratories / Q000592:standards*; D011786:Quality Control; D011933:Reagent Kits, Diagnostic / Q000592:standards; D012015:Reference Standards; D012016:Reference Values; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D011933:Reagent Kits, Diagnostic; D002784:Cholesterol
keywords: AK RMP; CDC; CRMLN; Certification; TC
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