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Ann Clin Biochem. 2016 Nov;53(6):632-639. doi: 10.1177/0004563215624461. Epub 2016 Sep 28.

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.

Author information

1
1 Lipid Reference Laboratory, Department of Preventive Cardiology, National Cerebral and Cardiovascular Center, Osaka, Japan.
2
2 Public Health, Department of Social Medicine, Graduate School of Medicine, Osaka University, Osaka, Japan.
3
3 Osaka Center for Cancer and Cardiovascular Disease Prevention, Osaka, Japan.
4
4 Chiba Prefectural Institute of Public Health/Osaka Prefecture University, Institution of Public Nutrition Practice, Chiba, Japan.
5
5 Department of Public Health Medicine, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan.
6
6 Department of Statistics and Data Analysis, Center for Cerebral and Cardiovascular Disease Information, National Cerebral and Cardiovascular Center, Osaka, Japan.
7
7 Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA, USA.
8
8 Teikyo Academic Research Center, Teikyo University, Tokyo, Japan.
9
9 Department of Preventive Cardiology, National Cerebral and Cardiovascular Center, Osaka, Japan.

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.

KEYWORDS:

Centers for Disease Control and Prevention standardization; GC-IDMS; chromotropic acid reference measurement procedure; enzymatic method; fluorometric method; triglycerides

PMID:
26680645
PMCID:
PMC5695560
DOI:
10.1177/0004563215624461
[Indexed for MEDLINE]
Free PMC Article

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