Search for


TEXT SIZE

search for



CrossRef (0)
Elecsys Vitamin D Total II 떆빟쓽 꽦뒫 룊媛
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.

議곗젙, 源쁽젙, 諛뺤젙샇, 源룞떇, 李⑥쁺醫, 씠삙寃
Eun Jung Cho, Hyunjung Kim, Jeongho Park, Dongsik Kim, Youngjong Cha, Hae Kyung Lee

媛넧由븰援 쓽젙遺꽦紐⑤퀝썝 吏꾨떒寃궗쓽븰怨

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
援먯떊옄: 씠삙寃 슦)11765 쓽젙遺떆 泥쒕낫濡 271, 媛넧由븰援 쓽젙遺꽦紐⑤퀝썝 吏꾨떒寃궗쓽븰怨 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

깉濡쒖슫 Elecsys vitamin D total II assay (Roche Diagnostics GmbH, Germany) 떆빟쓽 痢≪젙 꽦뒫쓣 룊媛빐蹂댁븯떎. 젙諛룄, 吏곸꽑꽦, 洹몃━怨 긽愿꽦쓣 Clinical and Laboratory Standards Institute 湲곗뿉 뵲씪 룊媛븯떎. 긽슜솕맂 젙룄愿由щЪ吏덇낵 솚옄 寃泥닿 룊媛뿉 궗슜릺뿀떎. 긽愿꽦 룊媛뿉꽌뒗 Access 25-hydroxyvitamin D total assay (Beckman Coulter Inc., USA)瑜 鍮꾧탳 떆빟쑝濡 궗슜븯떎. 珥 coefficients of variation뒗 5.1%-9.6%濡 굹궗怨, 吏곸꽑꽦 寃곌낵룄 룊媛븳 踰붿쐞 궡뿉꽌 留뚯”븷 留뚰븳 닔以씠뿀떎. 鍮꾧탳 옣鍮꾩쓽 긽愿꽦룄 슦닔븳 꽦쟻쓣 蹂댁뿬二쇱뿀떎. Elecsys vitamin D total II assay뒗 젙諛룄, 吏곸꽑꽦, 긽愿꽦 痢〓㈃뿉꽌 슦닔븳 遺꾩꽍 꽦뒫쓣 蹂댁뿬二쇱뼱 엫긽寃궗떎뿉꽌 쑀슜븯寃 궗슜븷 닔 엳쓣 寃껋쑝濡 깮媛곷맂떎.

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
Body

삁泥 諛 삁옣 以묒쓽 total 25-hydroxyvitamin D (25OH-D)瑜 쟾湲고솕븰諛쒓킅踰 썝由щ줈 痢≪젙븯뒗 Elecsys vitamin D total II assay (Roche Diagnostics GmbH, Mannheim, Germany) 떆빟쓽 꽦뒫쓣 룊媛빐蹂댁븯떎. 룊媛뒗 젙諛룄, 吏곸꽑꽦 諛 긽愿꽦뿉 븯뿬 씠猷⑥뼱議뚮떎. 젙諛룄뒗 몢 媛吏 냽룄쓽 젙룄愿由щЪ吏(PreciControl vitamin D total II level 1 lot no. 245476, level 2 lot no. 245477)瑜 씠슜븯뿬 룊媛븯떎. Clinical and Laboratory Standards Institute (CLSI) EP05-A3뿉 뵲씪 媛곴컖쓽 젙룄愿由щЪ吏덉쓣 20씪 룞븞 留ㅼ씪 2 run뵫, run떦 2쉶뵫 諛섎났 痢≪젙븯뿬 룊媛븯떎[1]. 吏곸꽑꽦 CLSI EP06-A뿉 뵲씪 룊媛븯떎[2]. 5媛吏 냽룄瑜 媛吏 VALIDATE VIT D (Maine Standards Co., LLC, ME, USA)瑜 씠슜븯뿬 媛곴컖 2쉶뵫 諛섎났 痢≪젙븯뿬 洹 寃곌낵瑜 씠슜븯뿬 吏곸꽑꽦쓣 룊媛븯떎. 긽愿꽦 CLSI EP09-A3뿉 뵲씪꽌 몴以寃궗踰뺤씤 liquid chromatography-tandem mass spectrometry (LC-MS/MS) 鍮꾧탳븯떎[3]. 떎뼇븳 냽룄瑜 媛吏 40媛 씠긽쓽 솚옄 寃泥대 씠슜븯뿬 LC-MS/MS Roche Modular Analytics E170뿉꽌 痢≪젙븯뿬 洹 寃곌낵瑜 鍮꾧탳븯떎. 媛 醫낅ぉ蹂 젙諛룄 룊媛寃곌낵瑜 Table 1뿉 젣떆븯떎. Fig. 1 吏곸꽑꽦 룊媛寃곌낵瑜 蹂댁뿬二쇰뒗 洹몃옒봽씠怨, Fig. 2뒗 긽愿꽦 룊媛寃곌낵瑜 蹂댁뿬二쇨퀬 엳떎. 媛 빆紐⑸퀎 젙諛룄 룊媛寃곌낵, 냽룄 諛 怨좊냽룄 젙룄愿由щЪ吏덉쓽 total coefficients of variation뒗 5.1% 9.6% 닔以쑝濡 紐⑤몢 留뚯”븷 留뚰븳 닔以씠뿀떎. 吏곸꽑꽦 룊媛뿉꽌 엫긽쟻쑝濡 以묒슂븳 냽룄 踰붿쐞뿉꽌 slope 0.948, intercept 0.000쑝濡 슦닔븳 吏곸꽑꽦씠 솗씤릺뿀怨, 젣議곗궗媛 젣떆븯뒗 吏곸꽑꽦쓽 踰붿쐞瑜 留뚯”븯떎. LC-MS/MS 긽愿꽦 룊媛寃곌낵 R=0.9456씠뿀쑝굹, 몢 諛⑸쾿 媛 mean bias뒗 8.4 ng/mL濡, Elecsys vitamin D total II assay踰뺤쓽 vitamin D媛믪씠 LC-MS/MS踰뺢낵 鍮꾧탳븯뿬 넂寃 愿李곕릺뿀떎. 씠뒗 옄룞솕 硫댁뿭痢≪젙踰뺣뱾씠 25OH-D2 삉뒗 vitamin D epimers뿉 쓽븳 援먯감諛섏쓳쑝濡 25OH-D 냽룄媛 넂寃 痢≪젙릺뒗 湲곗〈쓽 뿰援щ뱾怨 씪移섎릺뒗 냼寃ъ씠뿀떎[4,5]. 뵲씪꽌 Elecsys vitamin D total II뒗 엫긽寃궗떎뿉꽌 vitamin D 痢≪젙 떆빟쑝濡쒖꽌 쑀슜븯寃 궗슜븷 닔 엳쓣 寃껋쑝濡 湲곕맂떎.

Table 1 . Precision profile of Elecsys vitamin D total II assay.

AnalyteQuality control levelMeanCoefficient of variation (%)

Within-runBetween-runBetween-dayTotal
Vitamin D (ng/mL)Low12.6348.20.05.09.6
High27.8023.50.03.85.1

Figure 1.

Linearity studies using Elecsys vitamin D total II assay.


Figure 2.

Comparison of the Elecsys vitamin D total II assay and LC-MS/MS method. The scatter plot (A) and bias plot (B) are shown. Abbreviation: LC-MS/MS, liquid chromatography-tandem mass spectrometry.


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