title: Measurement performance of reagent manufacturers by Centers for Disease Control and Prevention/Cholesterol Reference Method Laboratory Network lipid standardization specified for metabolic syndrome-focused health checkups program in Japan.
abstract: OBJECTIVE
  This study was designed to clarify the current measurement performance of 7 reagent manufacturers for high-density lipoprotein cholesterol (HDLC), low-density lipoprotein cholesterol (LDLC) and triglycerides (TG) specified for the metabolic syndrome (MetS)-focused health checkups program in Japan.
  
  
  METHODS
  Twenty HDLC, 21 LDLC and 9 TG analytical reagent/instrument/calibrator systems (system), and combinations of reagent lots, instrument models and calibrator lots, underwent Centers for Disease Control and Prevention (CDC)/Cholesterol Reference Method Laboratory Network (CRMLN) lipid standardization. Eighty and 100% systems were requested to achieve an accuracy of within +/-1% and +/-2% of the reference value, so that a clinical laboratory can meet the CDC criteria.
  
  
  RESULTS
  The CDC performance criteria of HDLC, LDLC and TG require an accuracy of within +/-5%, +/-4% and +/-5%, respectively. For HDLC, all 20 systems met the criteria. Fourteen (70.0%) and 18 (90.0%) systems were within +/-1% and +/-2%, respectively. For LDLC, 14 (66.7%) of 21 systems met the criteria, but 7 (33.3%) failed. Five (23.8%) and 17 (81.0%) systems were within +/-1% and +/-2%, respectively. For TG, 8 of 9 systems met the criteria. Two (22.2%) and 4 (44.4%) systems were within +/-1% and +/-2%, respectively. The minimum and maximum differences of a specified sample among manufacturers were 1.6 and 11.0 mg/dL for HDLC, 7.8 and 33.0 mg/dL for LDLC, and 2.8 and 27.4 mg/dL for TG, respectively.
  
  
  CONCLUSIONS
  Homogeneous HDLC methods are acceptable for MetS, but further accuracy improvement of homogeneous LDLC and TG methods will be needed because of their poor performance.
authors.affiliation: Osaka Medical Center for Health Science and Promotion, Japan. xnakamura@kenkoukagaku.jp
authors.forename: Masakazu
authors.initials: M
authors.lastname: Nakamura
authors.forename: Isao
authors.initials: I
authors.lastname: Koyama
authors.forename: Hiroyasu
authors.initials: H
authors.lastname: Iso
authors.forename: Shinichi
authors.initials: S
authors.lastname: Sato
authors.forename: Mitsuyo
authors.initials: M
authors.lastname: Okazaki
authors.forename: Masahiko
authors.initials: M
authors.lastname: Kiyama
authors.forename: Takashi
authors.initials: T
authors.lastname: Shimamoto
authors.forename: Masamitsu
authors.initials: M
authors.lastname: Konishi
mesh_terms: D001774:Blood Chemical Analysis / Q000592:standards; D002138:Calibration / Q000592:standards; D002487:Centers for Disease Control and Prevention, U.S. / Q000592:standards; D002784:Cholesterol / Q000097:blood / Q000592:standards*; D008076:Cholesterol, HDL / Q000097:blood / Q000592:standards*; D006801:Humans; D007564:Japan; D007753:Laboratories / Q000592:standards; D008055:Lipids / Q000737:chemistry; D024821:Metabolic Syndrome / Q000097:blood / Q000175:diagnosis*; D011786:Quality Control; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D012016:Reference Values; D015203:Reproducibility of Results; D014481:United States
chemical_list: D008076:Cholesterol, HDL; D008055:Lipids; D011933:Reagent Kits, Diagnostic; D002784:Cholesterol