Commentary Note: Do We still Need Liquid Chromatography Combined with Mass Spectrometry for Therapeutic Drug Monitoring of Tacrolimus?

IF 1 4区医学 Q4 MEDICAL LABORATORY TECHNOLOGY

Annals of clinical and laboratory science Pub Date : 2026-01-01

Tracy Kisler, Melody Nelson, Amitava Dasgupta

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引用次数: 0

Abstract

Objective: In our laboratory, chemiluminescent microparticle immunoassay (CMIA) of tacrolimus on the Alinity i was implemented in February 2023 with an option for physicians to request liquid chromatography combined with mass spectrometry (LC-MS/MS) analysis to confirm the level of the immunoassay result.

Methods: CMIA tacrolimus was performed on the Alinity i analyzer and the result was reported within 4h. However, if a physician requested LC-MS/MS analysis, the same whole blood specimen was sent to the reference laboratory, where the result was available within 24h. We then compared the LC-MS/MS value with the initial immunoassay result, which was performed in the same specimen.

Results: From February 2, 2023, till November 18^th, 2025, 51,833 tacrolimus tests were ordered in our laboratory. Out of all these specimens only 795 specimens (1.53%) were sent to the reference laboratory for further analysis by LC-MS/MS as requested by ordering physicians. In the majority of specimens (634 out of 795, 79.7%) difference between immunoassay and LC-MS/MS was less than 20%. However, 27 specimens (3.4%) showed positive bias over 30% with a highest bias of 76.7%.

Conclusion: LC-MS/MS is still needed for therapeutic drug monitoring of tacrolimus.

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评论注：我们还需要液相色谱联用质谱法监测他克莫司的治疗药物吗？

目的：本实验室于2023年2月对Alinity i上的他克莫司进行化学发光微粒子免疫分析（CMIA），医师可要求液相色谱-质谱联用（LC-MS/MS）分析以确认免疫分析结果的水平。方法：他克莫司CMIA在Alinity i分析仪上检测，结果在4h内报告。但是，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，在24小时内获得结果。然后，我们将LC-MS/MS值与在同一标本中进行的初始免疫测定结果进行比较。结果：自2023年2月2日至2025年11月18日，本实验室订购他克莫司51833次。在所有样本中，只有795份（1.53%）样本按照订购医师的要求送到参比实验室进行LC-MS/MS进一步分析。在大多数标本中（795例中634例，79.7%），免疫测定法与LC-MS/MS的差异小于20%。27例（3.4%）标本阳性偏倚超过30%，最高偏倚达76.7%。结论：LC-MS/MS仍是他克莫司治疗药物监测的必要手段。

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 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.