Masakazu Nakamura1, Shinji Yokoyama2, Yuzo Kayamori3, Hiroyasu Iso4, Akihiko Kitamura4, Tomonori Okamura5, Masahiko Kiyama6, Hiroyuki Noda7, Kunihiro Nishimura8, Michikazu Nakai9, Isao Koyama10, Mahnaz Dasti11, Hubert W Vesper11, Tamio Teramoto12, Yoshihiro Miyamoto13. 1. National Cerebral and Cardiovascular Center, Department of Preventive Cardiology, Lipid Reference Laboratory, Japan. Electronic address: nakamura.masakazu.hp@ncvc.go.jp. 2. Nutritional Health Science Research Center, Chubu University, Japan. 3. Department of Health Sciences, Faculty of Medical Sciences, Kyushu University, Japan. 4. Public Health, Department of Social and Environmental Medicine, Graduate School of Medicine, Osaka University, Japan. 5. Department of Preventive Medicine and Public Health, Keio University, Japan. 6. Osaka Center for Cancer and Cardiovascular Disease Prevention, Japan. 7. 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. 8. National Cerebral and Cardiovascular Center, Department of Preventive Medicine and Epidemiologic Informatics, Office of Evidence-based Medicine and Risk Analysis, Japan. 9. National Cerebral and Cardiovascular Center, Department of Preventive Medicine and Epidemiologic Informatics, Japan. 10. National Cerebral and Cardiovascular Center, Department of Preventive Cardiology, Lipid Reference Laboratory, Japan. 11. Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, USA. 12. Teikyo Academic Research Center, Teikyo University, Japan. 13. National Cerebral and Cardiovascular Center, Department of Preventive Cardiology, Department of Preventive Medicine and Epidemiologic Informatics, Japan.
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.
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.
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