Performance Evaluation of Elecsys Vitamin D Total II Assay Using Roche Modular Analytics E170

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

doi:10.15263/jlmqa.2018.40.2.109

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Evaluation Brief

J Lab Med Qual Assur 2018; 40(2): 109-111

Published online June 30, 2018

https://doi.org/10.15263/jlmqa.2018.40.2.109

Performance Evaluation of Elecsys Vitamin D Total II Assay Using Roche Modular Analytics E170

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

Department of Laboratory Medicine, Uijeongbu St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Uijeongbu, Korea

Correspondence to:Hae-Kyung Lee Departments of Laboratory Medicine, Uijeongbu St. Mary’s 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
교신저자: 이혜경 우)11765 의정부시 천보로 271, 가톨릭대학교 의정부성모병원 진단검사의학과 Tel: 031)820-3159, Fax: 031)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

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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