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Performance Evaluation of Elecsys Vitamin D Total II Assay Using Roche Modular Analytics E170
J Lab Med Qual Assur 2018;40:109-111
Published online June 30, 2018
© 2018 Korean Association of External Quality Assessment Service.

Eun Jung Cho, Hyunjung Kim, Jeongho Park, Dongsik Kim, Youngjong Cha, and Hae Kyung Lee

Department of Laboratory Medicine, Uijeongbu St. Mary셲 Hospital, College of Medicine, The Catholic University of Korea, Uijeongbu, Korea
Correspondence to: Hae-Kyung Lee
Departments of Laboratory Medicine, Uijeongbu St. Mary셲 Hospital, College of Medicine, The Catholic University of Korea, 271 Cheonbo-ro, Uijeongbu 11765, Korea
Tel: +82-31-820-3159
Fax: +82-31-847-6266
E-mail: hkl@cathlic.ac.kr
Received March 23, 2018; Revised March 28, 2018; Accepted March 30, 2018.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
 Abstract
We evaluated the performance of a recently developed immunoassay, Elecsys vitamin D total II assay (Roche Diagnostics GmbH, Germany). Precision, linearity, and comparison studies were performed according to the Clinical and Laboratory Standards Institute guidelines. Control materials, linearity materials, and patient samples were used for the evaluation. For the correlation study, liquid chromatography-tandem mass spectrometry was used as the comparative method. Total coefficients of variations of the analyte were between 5.1% and 9.6%. The results of linearity evaluation were also acceptable for the range tested. Correlations with comparative methods were good; however, the mean values of the Elecsys vitamin D assay were higher than those of liquid chromatography-tandem mass spectrometry. The overall analytical performance of the Elecsys vitamin D total II assay is acceptable for the immunology analyzer. Therefore, the Elecsys vitamin D total II assay is expected to be widely used.
Keywords : Vitamin D, Performance, Evaluation
References
  1. Clinical and Laboratory Standards Institute. Evaluation of precision performance of quantitative measurement methods: approved guideline. 2nd ed. Wayne (PA): Clinical and Laboratory Standards Institute, 2014.
  2. Clinical and Laboratory Standards Institute. Evaluation of the linearity of quantitative measurement procedures:a statistical approach: approved guideline. Wayne (PA):Clinical and Laboratory Standards Institute, 2003.
  3. Clinical and Laboratory Standards Institute. Measurement procedure comparison and bias estimation using patient samples: approved guideline. 3rd ed. Wayne (PA):Clinical and Laboratory Standards Institute, 2013.
  4. Lee JH, Choi JH, Kweon OJ, Park AJ. Discrepancy between vitamin D total immunoassays due to various cross-reactivities. J Bone Metab 2015;22:107-12.
    Pubmed KoreaMed CrossRef
  5. Farrell CJ, Martin S, McWhinney B, Straub I, Williams P, Herrmann M. State-of-the-art vitamin D assays: a comparison of automated immunoassays with liquid chromatography-tandem mass spectrometry methods. Clin Chem 2012;58:531-42.
    Pubmed CrossRef