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

Details

• Alternative Title:
  Ann Clin Biochem
• Personal Author:
  Nakamura, Masakazu ; Iso, Hiroyasu ; Kitamura, Akihiko ; Imano, Hironori ; Noda, Hiroyuki ; Kiyama, Masahiko ; Sato, Shinichi ; Yamagishi, Kazumasa ; Nishimura, Kunihiro ; Nakai, Michikazu ; Vesper, Hubert W ; Teramoto, Tamio ; Miyamoto, Yoshihiro
• Description:
  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.
  
  
• Subjects:
  Article Centers For Disease Control And Prevention, U.S. Centers For Disease Control And Prevention Standardization Chemistry, Clinical Chromotropic Acid Reference Measurement Procedure Enzymatic Method Enzyme Assays Fluorometric Method Fluorometry GC-IDMS Humans Japan Laboratories Practice Guidelines As Topic Reference Values Triglycerides United States

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• Source:
  Ann Clin Biochem. 53(6):632-639
• Pubmed ID:
  26680645
• Pubmed Central ID:
  PMC5695560
• Document Type:
  Journal Article
• Funding:
  CC999999/Intramural CDC HHSUnited States/
• Volume:
  53
• Issue:
  6
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:21569c10282ce80d4cf218e1bed33216d674e7055c6d5f0a6d43d926abaf73d8
• Download URL:
  https://stacks.cdc.gov/view/cdc/49936/cdc_49936_DS1.pdf
• File Type:
  [PDF - 825.14 KB ]