title: HDL cholesterol performance using an ultracentrifugation reference measurement procedure and the designated comparison method.
abstract: BACKGROUND
  Accurate high-density lipoprotein cholesterol (HDL-C) measurements are important for management of cardiovascular diseases. The US Centers for Disease Control and Prevention (CDC) and Cholesterol Reference Method Laboratory Network (CRMLN) perform ultracentrifugation (UC) reference measurement procedure (RMP) to value assign HDL-C. Japanese CRMLN laboratory (Osaka) concurrently runs UC procedure and the designated comparison method (DCM). Osaka performance of UC and DCM was examined and compared with CDC RMP.
  
  
  METHODS
  CDC RMP involved UC, heparin-MnCl₂ precipitation, and cholesterol analysis. CRMLN DCM for samples containing <200 mg/dl triglycerides involved 50-kDa dextran sulfate-MgCl2 precipitation and cholesterol determination.
  
  
  RESULTS
  HDL-C regression equations obtained with CDC (x) and Osaka (y) were y=0.992x+0.542 (R(2)=0.996) for Osaka UC and y=1.004x-0.181 (R(2)=0.998) for DCM. Pass rates within ±1 mg/dl of the CDC target value were 91.9 and 92.1% for Osaka UC and DCM, respectively. Biases at 40 mg/dl HDL-C were +0.22 and -0.02 mg/dl for Osaka UC and DCM, respectively.
  
  
  CONCLUSIONS
  Osaka UC and DCM were highly accurate, precise, and stable for many years, assisting manufacturers to calibrate products for clinical laboratories to accurately measure HDL-C for patients, calculate non-HDL-C, and estimate low-density lipoprotein cholesterol with the Friedewald equation.
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: 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: Public Health, Department of Social and Environmental Medicine, Graduate School of Medicine, Osaka University, Japan.
authors.forename: Hiroyasu
authors.initials: H
authors.lastname: Iso
authors.affiliation: Public Health, Department of Social and Environmental Medicine, Graduate School of Medicine, Osaka University, Japan.
authors.forename: Akihiko
authors.initials: A
authors.lastname: Kitamura
authors.affiliation: Department of Preventive Medicine and Public Health, Keio University, Japan.
authors.forename: Tomonori
authors.initials: T
authors.lastname: Okamura
authors.affiliation: Osaka Center for Cancer and Cardiovascular Disease Prevention, Japan.
authors.forename: Masahiko
authors.initials: M
authors.lastname: Kiyama
authors.affiliation: Public Health, Department of Social and Environmental Medicine, Graduate School of Medicine, Osaka University, Japan; Cancer Control and Health Promotion Division, Health Service Bureau, Ministry of Health, Labour and Welfare, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Noda
authors.affiliation: National Cerebral and Cardiovascular Center, Department of Preventive Medicine and Epidemiologic Informatics, Office of Evidence-based Medicine and Risk Analysis, 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: National Cerebral and Cardiovascular Center, Department of Preventive Cardiology, Lipid Reference Laboratory, Japan.
authors.forename: Isao
authors.initials: I
authors.lastname: Koyama
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: D002487:Centers for Disease Control and Prevention, U.S.; D011232:Chemical Precipitation; D016264:Dextran Sulfate / Q000737:chemistry; D008075:Lipoproteins, HDL / Q000032:analysis* / Q000592:standards; D015636:Magnesium Chloride / Q000737:chemistry; D012015:Reference Standards; D012044:Regression Analysis; D014461:Ultracentrifugation / Q000379:methods* / Q000592:standards; D014481:United States
chemical_list: D008075:Lipoproteins, HDL; D015636:Magnesium Chloride; D016264:Dextran Sulfate
keywords: CDC; CRMLN; Designated comparison method; HDL cholesterol; Ultracentrifugation