Masakazu Nakamura1, Hiroyasu Iso2, Akihiko Kitamura2, Hironori Imano2, Masahiko Kiyama3, Shinji Yokoyama4, Yuzo Kayamori5, Isao Koyama6, Kunihiro Nishimura7, Michikazu Nakai7, Mahnaz Dasti8, Hubert W Vesper8, Tamio Teramoto9, Yoshihiro Miyamoto10. 1. National Cerebral and Cardiovascular Center, Department of Preventive Cardiology, Lipid Reference Laboratory, Japan. Electronic address: nakamura.masakazu.hp@ncvc.go.jp. 2. Public Health, Department of Social Medicine, Graduate School of Medicine, Osaka University, Japan. 3. Osaka Center for Cancer and Cardiovascular Disease Prevention, Japan. 4. Nutritional Health Science Research Center, Chubu University, Japan. 5. Department of Health Sciences, Faculty of Medical Sciences, Kyushu University, Japan. 6. National Cerebral and Cardiovascular Center, Department of Preventive Cardiology, Lipid Reference Laboratory, Japan. 7. National Cerebral and Cardiovascular Center, Department of Preventive Medicine and Epidemiologic Informatics, Japan. 8. Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, USA. 9. Teikyo Academic Research Center, Teikyo University, Japan. 10. National Cerebral and Cardiovascular Center, Department of Preventive Cardiology, Department of Preventive Medicine and Epidemiologic Informatics, Japan.
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.
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: G R Cooper; S J Smith; I W Duncan; A Mather; W D Fellows; T Foley; I D Frantz; J B Gill; T A Grooms; I Hynie Journal: Clin Chem Date: 1986-06 Impact factor: 8.327