Technical Note: Experience of Implementing Tacrolimus Immunoassay on the Alinity i Analyzer in an Academic Medical Center: Small Percentage of Specimens Were Sent to Reference Laboratory for LC-MS/MS Analysis.

IF 1.1 4区 医学 Q4 MEDICAL LABORATORY TECHNOLOGY
Melody Nelson, Tracy Kisler, Kelsey Woodard, Amitava Dasgupta
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Abstract

Objective: Liquid chromatography combined with tandem mass spectrometry (LC-MS/MS) is considered the gold standard for analysis of tacrolimus as this method is free from metabolite interferences. Due to complexity of analysis and initial high cost, many hospital laboratories use immunoassays for routine monitoring of tacrolimus. In 2023, we implemented a Federal Food and Drug Administration (FDA) approved Chemiluminescent microparticle immunoassay (CMIA) of tacrolimus on the Alinity i analyzer with an option for physicians to request LC-MS/MS analysis if they were not satisfied with the immunoassay result.

Methods: CMIA tacrolimus was performed on the Alinity i analyzer, and the result was reported within four hours. After evaluating a particular tacrolimus result, if a physician requested LC-MS/MS analysis, the same whole blood specimen was sent to the reference laboratory. Then, we compared LC-MS/MS value with initial immunoassay result.

Results: In a 12-month period, 25,897 tacrolimus tests were ordered by physicians. Only 388 specimens (1.49%) were sent to the reference laboratory for LC-MS/MS analysis. The overall correlation between LC-MS/MS value (x-axis) and immunoassay result was excellent (y=1.045x+0.652, r=0.96, n=388). Out of 388 specimens, only 70 specimens were considered discordant due to more than 20% bias between the LC-MS/MS and immunoassay values. When these specimens were compared, the regression equation was 1.277x+0.412, r=0.95.

Conclusions: The CMIA assay on the Alinity i analyzer is suitable for routine therapeutic drug monitoring of tacrolimus with high physician satisfaction.

技术说明:某学术医疗中心在Alinity i分析仪上实施他克莫司免疫测定的经验:一小部分标本被送到参比实验室进行LC-MS/MS分析。
目的:液相色谱-串联质谱法(LC-MS/MS)无代谢物干扰,被认为是分析他克莫司的金标准。由于分析的复杂性和最初的高成本,许多医院实验室使用免疫测定法进行他克莫司的常规监测。2023年,我们在Alinity i分析仪上实施了联邦食品和药物管理局(FDA)批准的他克莫司化学发光微粒免疫测定(CMIA),如果医生对免疫测定结果不满意,可以选择LC-MS/MS分析。方法:CMIA他克莫司在Alinity i分析仪上检测,结果在4小时内报告。在评估特定的他克莫司结果后,如果医生要求LC-MS/MS分析,则将相同的全血标本送到参比实验室。然后将LC-MS/MS值与初始免疫测定结果进行比较。结果:在12个月期间,医生订购了25,897次他克莫司试验。只有388份标本(1.49%)送到参比实验室进行LC-MS/MS分析。LC-MS/MS值(x轴)与免疫测定结果总体相关性极好(y=1.045x+0.652, r=0.96, n=388)。在388个标本中,由于LC-MS/MS和免疫测定值之间的偏差超过20%,只有70个标本被认为不一致。当这些标本比较时,回归方程为1.277x+0.412, r=0.95。结论:Alinity i分析仪CMIA法适用于他克莫司常规治疗药物监测,医师满意度高。
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
Annals of clinical and laboratory science
Annals of clinical and laboratory science 医学-医学实验技术
CiteScore
1.60
自引率
0.00%
发文量
112
审稿时长
6-12 weeks
期刊介绍: The Annals of Clinical & Laboratory Science welcomes manuscripts that report research in clinical science, including pathology, clinical chemistry, biotechnology, molecular biology, cytogenetics, microbiology, immunology, hematology, transfusion medicine, organ and tissue transplantation, therapeutics, toxicology, and clinical informatics.
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