Good correlation between tacrolimus concentrations using improved CMIA on the Alinity i analyzer and LC-MS/MS method from a reference laboratory but unexpected negative bias with another LC-MS/MS method from a different reference laboratory.

IF 1.9 4区医学 Q2 PATHOLOGY American journal of clinical pathology Pub Date : 2024-07-05 DOI:10.1093/ajcp/aqae005

Kelsey Woodard, Tracey Kisler, Amitava Dasgupta

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Abstract

Objectives: We compared tacrolimus concentrations obtained by the more recently US Food and Drug Administration-approved tacrolimus assay (CMIA) on the Alinity i analyzer (Abbott Laboratories) with a liquid chromatography/tandem mass spectrometry (LC-MS/MS)-based method from 2 reference laboratories. We also investigated the correlation between the CMIA tacrolimus and Elecsys tacrolimus assays.

Methods: Tacrolimus concentrations were measured in EDTA whole blood by the chemiluminescent microparticle immunoassay (CMIA) using the Alinity i analyzer, and then 2 aliquots were sent to 2 reference laboratories, both using ascomycin as the internal standard for the LC-MS/MS method.

Results: The total precision of the CMIA tacrolimus assay was excellent. When tacrolimus concentrations obtained by the LC-MS/MS method from reference laboratory A were plotted on the x-axis and corresponding CMIA values were plotted on the y-axis, the following regression equation was observed: y = 0.9721x + 1.005 (r = 0.95), indicating no significant bias with the CMIA. However, when tacrolimus values obtained from reference laboratory B were used for comparison, the regression equation was y = 0.7664x + 1.775 (r = 0.93), indicating significant negative bias with the CMIA. When we compared tacrolimus concentrations obtained by reference laboratories A and B, we observed positive bias with tacrolimus concentrations obtained by reference laboratory B. However, tacrolimus concentrations obtained by both CMIA and Elecsys immunoassays were comparable.

Conclusions: Because of good correlation of tacrolimus concentrations using the CMIA and LC-MS/MS from reference laboratory A, our long-term reference laboratory for drug analysis, we concluded that the CMIA on the Alinity i can be used for therapeutic drug monitoring of tacrolimus.

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在 Alinity i 分析仪上使用改进的 CMIA 与一家参考实验室的 LC-MS/MS 方法之间的他克莫司浓度具有良好的相关性，但与另一家参考实验室的 LC-MS/MS 方法之间却出现了意想不到的负偏差。

研究目的我们比较了 Alinity i 分析仪（雅培实验室）上最新获得美国食品和药物管理局批准的他克莫司测定法（CMIA）和 2 家参考实验室基于液相色谱/串联质谱（LC-MS/MS）的方法得出的他克莫司浓度。我们还研究了 CMIA 他克莫司检测法与 Elecsys 他克莫司检测法之间的相关性：方法：使用 Alinity i 分析仪通过化学发光微粒子免疫分析法（CMIA）测定 EDTA 全血中他克莫司的浓度，然后将 2 份等分样品送至 2 个参考实验室，这 2 个实验室均使用阿霉素作为 LC-MS/MS 方法的内标：结果：CMIA 他克莫司测定法的总精密度非常高。将参考实验室 A 用 LC-MS/MS 方法获得的他克莫司浓度绘制在 x 轴上，相应的 CMIA 值绘制在 y 轴上，可观察到以下回归方程：y = 0.9721x + 1.005（r = 0.95），表明 CMIA 无明显偏差。然而，当使用参考实验室 B 的他克莫司值进行比较时，回归方程为 y = 0.7664x + 1.775（r = 0.93），表明 CMIA 存在明显的负偏差。当我们比较参考实验室 A 和 B 所获得的他克莫司浓度时，我们发现参考实验室 B 所获得的他克莫司浓度存在正偏差，但 CMIA 和 Elecsys 免疫测定法所获得的他克莫司浓度相当：由于使用 CMIA 和参考实验室 A（我们的长期药物分析参考实验室）的 LC-MS/MS 测得的他克莫司浓度具有良好的相关性，我们认为 Alinity i 上的 CMIA 可用于他克莫司的治疗药物监测。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

American journal of clinical pathology 医学-病理学

CiteScore

7.70

自引率

2.90%

发文量

367

审稿时长

3-6 weeks

期刊介绍： The American Journal of Clinical Pathology (AJCP) is the official journal of the American Society for Clinical Pathology and the Academy of Clinical Laboratory Physicians and Scientists. It is a leading international journal for publication of articles concerning novel anatomic pathology and laboratory medicine observations on human disease. AJCP emphasizes articles that focus on the application of evolving technologies for the diagnosis and characterization of diseases and conditions, as well as those that have a direct link toward improving patient care.