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Six Sigma Analysis of Vitamin D Measurement Using External Quality Assessment Program
Korean J Clin Lab Sci 2020;52:91-97  
Published on June 30, 2020
Copyright © 2020 Korean Society for Clinical Laboratory Science.

Myungsuk Ji

Department of Laboratory Medicine, Kangbuk Samsung Hospital, Seoul, Korea
Correspondence to: Myungsuk Ji
Department of Laboratory Medicine, Kangbuk Samsung Hospital, 29 Saemunan-ro, Jongno-gu, Seoul 03181, Korea
E-mail: ms.gee@samsung.com
ORCID: https://orcid.org/0000-0001-7536-0367
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Standardization of vitamin analysis continues around the world, and much effort has been made to improve the accuracy of the results. This study analyzed the sigma metrics of the vitamin D test using the external quality assessment (EQA) program. Sigma metrics is used for quantitative tests performed in the laboratory, and the test results can be objectively visualized in terms of quality. This analysis was performed based on the accuracy of the College of American Pathologists (CAP) using the results of the 2019 accuracy-based vitamin D (ABVD) survey, and about 300 laboratories participated in the survey. Reference values were obtained by the Center for Disease Control and Prevention (CDC) reference laboratory. At six different concentrations, the sigma metrics were analyzed to be 1.00, 1.85, 2.42, 1.01, 1.54 and 0.78, respectively. An average of 1.43 sigma metrics was determined. In particular, only positive biases for ABVD-16 and 17 were shown in the liquid chromatography tandem-mass spectrometry (LC-MS/MS), which is the standard method for vitamin D determination when compared to the reference values. The causes of the difference can be explained by cross reactivity to various vitamin D metabolites. Laboratories need to improve their overall performance.
Keywords : Liquid chromatography-tandem mass spectrometry, Sigma metrics, Vitamin D

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