Cobas Pure Integrated Solutions에서의 Tacrolimus 전기화학발광 면역측정법의 성능평가
Performance of Tacrolimus Electrochemiluminescence Immunoassay on Cobas Pure Integrated Solutions
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배경: Cobas Pure integrated solutions (Roche Diagnostics International AG, Switzerland)는 임상화학, 면역분석 및 이온선택전극 진단검사를 하나의 플랫폼에서 시행할 수 있는 신규 출시된 자동분석기이다. 본 연구에서는 Cobas Pure platform에서의 tacrolimus electrochemiluminescence immunoassay (ECLIA)의 수행능을 평가하였으며, 이를 affinity chrome-mediated immunoassay (ACMIA)와 liquid chromatography-tandem mass spectrometry (LC-MS/MS) 법과 비교하였다. 방법: Tacrolimus 정도관리물질 및 복용 중인 환자의 잔여 전혈 검체를 Cobas Pure에서의 tacrolimus ECLIA 평가에 사용하였다. 평가는 Clinical and Laboratory Standards Institute (CLSI) EP5-A3에 따른 정밀도, CLSI EP6-A에 따른 직선성, CLSI EP9-A3에 따른 방법간 비교 및 carryover를 포함하였다. 방법 간 비교는 Cobas Pure에서의 tacrolimus ECLIA 결과를 tacrolimus ACMIA (Siemens Healthineers, USA)와 LC-MS/MS (Waters Corporation, USA) 결과와 비교하였다. 결과: 검사실 내 정밀도는 저, 중, 고농도에서 각각 4.0%, 3.1%, 3.2%였고, 0.91 ng/mL – 27.43 ng/mL 범위 내에서 직선성을 보였다. Cobas Pure의 tacrolimus ECLIA 측정결과는 ACMIA와는 0.977, LC-MS/MS와는 0.994의 상관계수를 보였으나 약간의 차이를 보였다. Carryover 효과는 0.03%였다. 결론: Cobas Pure platform에서의 tacrolimus ECLIA 수행능 평가 결과, 허용 가능한 정밀도, 직선성 및 타 검사법과의 상관성을 보였으나 약간의 차이를 보였다. 따라서 본 연구 결과 임상 검사실에서의 tacrolimus 치료적 모니터링에 사용하기 적합할 것으로 판단된다.
Abstract
Background: Cobas pure integrated solutions (Roche Diagnostics International AG, Switzerland) is a newly launched automatic analyzer combining clinical chemistry, immunoassay, and ion-selective electrode diagnostic testing. We evaluated the analytical performance of tacrolimus electrochemiluminescence immunoassay (ECLIA) on cobas pure and compared it with that of affinity chrome-mediated immunoassay (ACMIA) and liquid chromatography tandem mass spectrometry (LC-MS/MS). Methods: Quality control materials and residual whole blood samples from patients receiving tacrolimus were used in evaluating the performance metrics, including the precision, linearity, comparison, and carryover, of tacrolimus ECLIA (Roche Diagnostics GmbH, Germany) on cobas pure. The precision, linearity, and comparison were assessed in accordance with Clinical and Laboratory Standards Institute guidelines EP5-A3, EP6-A, and EP9-A3, respectively, and the carryover was calculated. Results of tacrolimus ECLIA on cobas pure were compared with those of tacrolimus ACMIA (Siemens Healthineers, USA) and LC-MS/MS (Waters Corporation, USA) on other platforms. Results: The within-laboratory precisions of tacrolimus ECLIA on cobas pure were 4.0%, 3.1%, and 3.2% at low, medium, and high concentrations of quality control materials. The linearity of the assay was acceptable (0.91–27.43 ng/mL). Correlation analysis indicated that the results of tacrolimus ECLIA on cobas pure were comparable to those of Dimension TAC and LC-MS/MS (r=0.977 and 0.994, respectively) with slight difference. Moreover, the carryover effect was 0.03%. Conclusions: Tacrolimus ECLIA on cobas pure showed acceptable precision, linearity, and correlation with ACMIA and LC-MS/MS except for a slight difference. The overall performance of tacrolimus ECLIA on cobas pure is suitable for the therapeutic drug monitoring of tacrolimus in clinical laboratories.
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