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Performance Evaluation of the ARCHITECT i2000 for the Determination of Whole Blood Cyclosporin A and Tacrolimus
J Lab Med Qual Assur 2019;41:117-119
Published online June 30, 2019
© 2019 Korean Association of External Quality Assessment Service.

Misun Lim and Yong-Wha Lee

Department of Laboratory Medicine and Genetics, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Korea
Correspondence to: Yong-Wha Lee, Department of Laboratory Medicine and Genetics, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, 170 Jomaruro, Wonmi-gu, Bucheon 14584, Korea, Tel: +82-32-621-5943 Fax: +82-32-621-5944 E-mail: lywmd@daum.net
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

Maintaining immunosuppressant concentrations within the therapeutic range in organ recipients requires regular monitoring. The blood concentrations of immunosuppressants are routinely measured using one of several automated immunoassays, such as chemiluminescence immunoassays (CLIAs) and liquid chromatography-tandem mass spectrometry (LC-TMS). The ARCHITECT i2000 immunoassay analyzer (Abbott Diagnostics, USA) was developed as an automated CLIA analyzer for the measurement of cyclosporin A and tacrolimus in whole blood. Here, the precision and linearity of the ARCHITECT i2000 analyzer for the detection of cyclosporin A and tacrolimus in whole blood were evaluated according to Clinical and Laboratory Standards Institute guidelines and were compared with those of an LC-TMS detection method. The total coefficient of variation for the two drugs was less than 10%, and they showed linearity values of 0.97 or more, which was within the manufacturer’s range. The measurements of both immunosuppressants by the ARCHITECT i2000 were closely correlated with measurements determined by LC-TMS. However, most measurements were lower with LC-TMS than with the ARCHITECT i2000. Measurement of cyclosporin A and tacrolimus in whole blood using the ARCHITECT i2000 showed very satisfactory performance in terms of precision and linearity as well as good correlation with the comparative method.

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씠떇 솚옄뿉꽌 硫댁뿭뼲젣젣 닾뿬 떆 移섎즺쟻 빟臾쇰냽룄 援ш컙쓣 쑀吏븯怨 룆꽦쓣 理쒖냼솕븯硫 씠떇 嫄곕쐞뿕쓣 理쒖냼솕븯湲 쐞빐 吏냽쟻쑝濡 cyclosporin A tacrolimus 벑쓽 硫댁뿭뼲젣젣뿉 븳 삁以묐냽룄 紐⑤땲꽣留곸씠 슂援щ맂떎. 빟臾쇰냽룄쓽 몴以痢≪젙 踰뺤쑝濡 痢≪젙臾쇱쭏뿉 븳 듅씠룄 젙솗룄瑜 넂씤 븸泥 겕濡쒕쭏 넗洹몃옒뵾 吏덈웾遺꾩꽍踰뺤씠 씠슜맆 닔 엳쑝굹 떆媛꾧낵 鍮꾩슜씠 留롮씠 냼슂릺뒗 떒젏씠 엳떎[1]. 洹쇰옒뿉 솕븰諛쒓킅 硫댁뿭痢≪젙踰 썝由ш 쟻슜맂 옄룞솕 硫댁뿭遺꾩꽍湲곌린濡쒖꽌 떎뼇븳 몴吏옄寃궗瑜 닔뻾븷 닔 엳뒗 ARCHITECT i2000 (Abbott Diagnostics, Abbott Park, IL, USA)媛 엫긽寃궗떎뿉꽌 삁以 빟臾쇰냽룄뿉 留롮씠 씠슜릺怨 엳떎[2].

蹂 뿰援ъ뿉꽌뒗 Clinical and Laboratory Standards Institute (CLSI)뿉 젣떆맂 룊媛吏移⑥뿉 뵲씪 ARCHITECT i2000쓣 씠슜븯뿬 痢≪젙븳 삁以 cyclosporin A tacrolimus 냽룄뿉 븯뿬 젙諛룄, 吏곸꽑꽦怨 긽愿꽦쓣 룊媛븯떎[3-5]. Cyclosporin A tacrolimus寃궗媛 쓽猶곕맂 쟾삁 寃泥댁 궡遺 젙룄愿由ъ슜 臾쇱쭏쓣 씠슜븯뿬 룊媛븯떎. 몢 醫낅ぉ뿉 빐 꽭 냽룄쓽 젙룄愿由ъ슜 臾쇱쭏쓣 씠슜븯뿬 CLSI 湲곗뿉 留욎텛뼱 5씪媛 삤쟾·삤썑뿉 諛섎났寃궗 닔뻾 썑 珥 蹂씠怨꾩닔瑜 援ы븯怨, 怨좊냽룄 냽룄쓽 臾쇱쭏쓣 씠슜븯뿬 5媛吏 냽룄濡 씗꽍 썑 諛섎났 痢≪젙븯뿬 吏곸꽑꽦쓣 蹂댁씠뒗 援ш컙쓣 寃利앺븯쑝硫, 3,600媛 쓽 떎뼇븳 媛믪쓣 蹂댁씠뒗 寃泥대 씠슜븯뿬 븸泥 겕濡쒕쭏넗洹몃옒뵾 吏덈웾遺꾩꽍踰뺤씠 쟻슜맂 Waters Acquity UPLC TQ-Detector (Waters Corp., Milford, MA, USA)쓽 긽愿꽦쓣 Passing-Bablok 쉶洹떇쓣 씠슜븯뿬 룊媛븯떎.

媛곴컖쓽 룊媛뿉 븳 넻怨꾨뒗 Microsoft Office Excel 2013 (Microsoft Corp., Redmond, WA, USA) 봽濡쒓렇옩쓣 씠슜븯뿬 遺꾩꽍븯떎.

몢 醫낅ぉ쓽 珥 蹂씠怨꾩닔뒗 怨좊냽룄臾쇱쭏 8.0%-8.3%쓽 媛믪쓣 蹂댁怨 냽룄臾쇱쭏 5.8%-9.3%쓽 媛믪쓣 蹂댁떎(Table 1). 吏곸꽑꽦 룊媛뿉꽌 몢 醫낅ぉ 紐⑤몢 젣議곗궗 젣떆踰붿쐞 궡뿉꽌 寃곗젙怨꾩닔媛 0.97 씠긽씠뿀떎(Table 2). 븸泥 겕濡쒕쭏넗洹몃옒뵾 吏덈웾遺꾩꽍 踰뺢낵쓽 긽愿꽦 룊媛뿉꽌 몢 醫낅ぉ 紐⑤몢 긽愿怨꾩닔媛 0.9 씠긽쑝濡 굹굹 諛젒븳 긽愿꽦쓣 蹂댁쑝굹 븸泥 겕濡쒕쭏넗洹몃옒뵾 吏덈웾遺꾩꽍쑝濡 痢≪젙맂 寃곌낵쓽 遺遺꾩씠 ARCHITECT i2000쑝濡 痢≪젙맂 寃곌낵蹂대떎 cyclosporine A tacrolimus 媛곴컖 룊洹좎쟻쑝 濡 12.0% 3.7% 궙 寃껋쑝濡 愿李곕릺뿀떎(Figs. 1, 2).

Table 1 . Precision of cyclosporin A and tacrolimus measurement by the ARCHITECT i2000 with high-, medium-, and low-level quality control materials (controls 1, 2, and 3).

Items (units)LevelMean±standard deviationCoefficient of variation (%)Desirable precision (%)*
Cyclosporin A (ng/mL)Low78.7±7.299.315.0
Medium273.5±19.507.4
High722.4±59.808.3
Tacrolimus (ng/mL)Low3.8±0.225.810.0
Medium8.9±0.596.6
High18.6±1.588.0

The instrument used was from the following company: ARCHITECT i2000 (Abbott Diagnostics, Abbott Park, IL, USA)..

*Based on the manufacturer’s criteria.


Table 2 . Linearity of cyclosporine A and tacrolimus measurement by the ARCHITECT i2000.

ItemsUnitsLinearity rangeR2Best fit
Cyclosporin Ang/mL40–1,5000.999Linear
Tacrolimusng/mL3–300.994Linear

The instrument used was from the following company: ARCHITECT i2000 (Abbott Diagnostics, Abbott Park, IL, USA)..


Figure 1.

Comparison of whole blood cyclosporin A measurement by ultra performance liquid chromatography with tandem mass spectrometry and the ARCHITECT i2000, which uses a chemiluminescence immunoassay method. (A) Passing and Bablok regression plot and (B) Bland-Altman plot. The instrument used was from the following company: ARCHITECT i2000 (Abbott Diagnostics, Abbott Park, IL, USA). Abbreviation: LC-TMS, liquid chromatography-tandem mass spectrometry.


Figure 2.

Comparison of whole blood tacrolimus measurement by ultra performance liquid chromatography with tandem mass spectrometry and the ARCHITECT i2000, which uses a chemiluminescence immunoassay method. (A) Passing and Bablok regression plot and (B) Bland-Altman plot. The instrument used was from the following company: ARCHITECT i2000 (Abbott Diagnostics, Abbott Park, IL, USA). Abbreviation: LC-TMS, liquid chromatography-tandem mass spectrometry.


ARCHITECT i2000쓣 씠슜븳 삁以 cyclosporin A tacrolimus 냽룄 痢≪젙 젙諛룄 吏곸꽑꽦뿉 엳뼱꽌 留ㅼ슦 留뚯”븷 留뚰븳 꽦뒫쓣 蹂댁怨, 븸泥 겕濡쒕쭏넗겕옒뵾 吏덈웾遺꾩꽍踰뺢낵룄 醫뗭 긽愿꽦쓣 蹂댁떎. ARCHITECT i2000쓣 씠슜븳 삁以 cyclosporin A tacrolimus 냽룄 痢≪젙 씠떇 솚옄뿉꽌 吏냽쟻쑝濡 cyclosporin A tacrolimus 벑쓽 硫댁뿭뼲젣젣뿉 븳 떊냽븯怨 젙솗븳 삁以묐냽룄 紐⑤땲꽣留곸씠 媛뒫븳 쑀슜븳 寃궗踰뺤쑝濡 룊媛릺뿀떎.

媛먯궗쓽 湲

蹂 뿰援ъ뿉 吏썝쓣 븘겮吏 븡 븳援븷蹂댄듃닚뿉 源딆 媛먯궗瑜 뱶由곕떎.

References
  1. Poquette MA, Lensmeyer GL, Doran TC. Effective use of liquid chromatography-mass spectrometry (LC/MS) in the routine clinical laboratory for monitoring sirolimus, tacrolimus, and cyclosporine. Ther Drug Monit 2005;27:144-50.
    Pubmed CrossRef
  2. Wu AH. A selected history and future of immunoassay development and applications in clinical chemistry. Clin Chim Acta 2006;369:119-24.
    Pubmed CrossRef
  3. Clinical and Laboratory Standard Institute. Evaluation of the precision performance of clinical chemistry devices: approved guideline second edition (EP5-A2). Wayne (PA): Clinical and Laboratory Standard Institute, 2004.
  4. Clinical and Laboratory Standard Institute. Evaluation of the linearity of quantitative measurement procedures: a statistical approach; approved guideline (EP6-A). Wayne (PA): Clinical and Laboratory Standard Institute, 2003.
  5. Clinical and Laboratory Standard Institute. Method comparison and bias estimation using patient samples: approved guideline second edition (EP9-A2). Wayne (PA): Clinical and Laboratory Standard Institute, 2002.