title: Comparison between the triglycerides standardization of routine methods used in Japan and the chromotropic acid reference measurement procedure used by the CDC Lipid Standardization Programme.
abstract: Background The US Centers for Disease Control and Prevention ensured adequate performance of the routine triglycerides methods used in Japan by a chromotropic acid reference measurement procedure used by the Centers for Disease Control and Prevention lipid standardization programme as a reference point. We examined standardized data to clarify the performance of routine triglycerides methods. Methods The two routine triglycerides methods were the fluorometric method of Kessler and Lederer and the enzymatic method. The methods were standardized using 495 Centers for Disease Control and Prevention reference pools with 98 different concentrations ranging between 0.37 and 5.15 mmol/L in 141 survey runs. The triglycerides criteria for laboratories which perform triglycerides analyses are used: accuracy, as bias ≤5% from the Centers for Disease Control and Prevention reference value and precision, as measured by CV, ≤5%. Results The correlation of the bias of both methods to the Centers for Disease Control and Prevention reference method was: y (%bias) = 0.516 × (Centers for Disease Control and Prevention reference value) -1.292 ( n = 495, R2= 0.018). Triglycerides bias at medical decision points of 1.13, 1.69 and 2.26 mmol/L was -0.71%, -0.42% and -0.13%, respectively. For the combined precision, the equation y (CV) = -0.398 × (triglycerides value) + 1.797 ( n = 495, R2= 0.081) was used. Precision was 1.35%, 1.12% and 0.90%, respectively. It was shown that triglycerides measurements at Osaka were stable for 36 years. Conclusions The epidemiologic laboratory in Japan met acceptable accuracy goals for 88.7% of all samples, and met acceptable precision goals for 97.8% of all samples measured through the Centers for Disease Control and Prevention lipid standardization programme and demonstrated stable results for an extended period of time.
authors.affiliation: 1 Lipid Reference Laboratory, Department of Preventive Cardiology, National Cerebral and Cardiovascular Center, Osaka, Japan.
authors.forename: Masakazu
authors.initials: M
authors.lastname: Nakamura
authors.affiliation: 2 Public Health, Department of Social Medicine, Graduate School of Medicine, Osaka University, Osaka, Japan.
authors.forename: Hiroyasu
authors.initials: H
authors.lastname: Iso
authors.affiliation: 2 Public Health, Department of Social Medicine, Graduate School of Medicine, Osaka University, Osaka, Japan.
authors.forename: Akihiko
authors.initials: A
authors.lastname: Kitamura
authors.affiliation: 2 Public Health, Department of Social Medicine, Graduate School of Medicine, Osaka University, Osaka, Japan.
authors.forename: Hironori
authors.initials: H
authors.lastname: Imano
authors.affiliation: 2 Public Health, Department of Social Medicine, Graduate School of Medicine, Osaka University, Osaka, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Noda
authors.affiliation: 3 Osaka Center for Cancer and Cardiovascular Disease Prevention, Osaka, Japan.
authors.forename: Masahiko
authors.initials: M
authors.lastname: Kiyama
authors.affiliation: 4 Chiba Prefectural Institute of Public Health/Osaka Prefecture University, Institution of Public Nutrition Practice, Chiba, Japan.
authors.forename: Shinichi
authors.initials: S
authors.lastname: Sato
authors.affiliation: 5 Department of Public Health Medicine, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan.
authors.forename: Kazumasa
authors.initials: K
authors.lastname: Yamagishi
authors.affiliation: 6 Department of Statistics and Data Analysis, Center for Cerebral and Cardiovascular Disease Information, National Cerebral and Cardiovascular Center, Osaka, Japan.
authors.forename: Kunihiro
authors.initials: K
authors.lastname: Nishimura
authors.affiliation: 6 Department of Statistics and Data Analysis, Center for Cerebral and Cardiovascular Disease Information, National Cerebral and Cardiovascular Center, Osaka, Japan.
authors.forename: Michikazu
authors.initials: M
authors.lastname: Nakai
authors.affiliation: 7 Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA, USA.
authors.forename: Hubert W
authors.initials: HW
authors.lastname: Vesper
authors.affiliation: 8 Teikyo Academic Research Center, Teikyo University, Tokyo, Japan.
authors.forename: Tamio
authors.initials: T
authors.lastname: Teramoto
authors.affiliation: 9 Department of Preventive Cardiology, National Cerebral and Cardiovascular Center, Osaka, Japan.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Miyamoto
mesh_terms: D002487:Centers for Disease Control and Prevention, U.S.; D002624:Chemistry, Clinical / Q000379:methods / Q000592:standards*; D057075:Enzyme Assays / Q000592:standards*; D005470:Fluorometry / Q000592:standards*; D006801:Humans; D007564:Japan; D007753:Laboratories / Q000592:standards; D017410:Practice Guidelines as Topic; D012016:Reference Values; D014280:Triglycerides / Q000097:blood*; D014481:United States
chemical_list: D014280:Triglycerides
keywords: Centers for Disease Control and Prevention standardization; GC-IDMS; chromotropic acid reference measurement procedure; enzymatic method; fluorometric method; triglycerides