全自动LC-MS/MS:准备好用于临床常规实验室了吗?

IF 3.1 4区医学 Q2 MEDICAL LABORATORY TECHNOLOGY Journal of Mass Spectrometry and Advances in the Clinical Lab Pub Date : 2023-08-02 DOI:10.1016/j.jmsacl.2023.07.001

Sina Junger , Miriam Hoene , Maria Shipkova , Gudrun Danzl , Christof Schöberl , Andreas Peter , Rainer Lehmann , Eberhard Wieland , Helmine Braitmaier

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摘要

液相色谱-串联质谱（LC-MS/MS）是一种灵敏度高、特异性强的方法。然而，由于其高度复杂性和缺乏自动化，它在临床实验室的常规使用受到阻碍。研究表明，在医院常规实验室中，使用首个全自动LC-MS/MS对25-羟基维生素D和免疫抑制剂（ISD）进行分析，具有优异的分析性能。目的我们的目标是（1）验证自动LC-MS/MS在商业实验室中的适用性，这与医院实验室的需求不同；（2）检查其在不同专业背景的操作员中的可用性。方法我们评估了维生素D和ISDs环孢菌素A和他克莫司在五个月内的分析测定性能。将这些测定与医院实验室中的相同分析仪、内部LC-MS/MS方法和化学发光微粒免疫测定（CMIA）进行比较。九名操作员通过结构化问卷对全自动LC-MS/MS系统的可用性进行了评估。结果该自动化系统具有较高的精密度（CV<；8%）、准确度（偏倚<；7%），与外部质量评价（EQA）样品的浓度符合良好。在医院常规实验室中使用相同的分析仪获得了可比较的结果。25-OH维生素D3（-10.6%）、环孢菌素A（-4.3%）和他克莫司（-6.6%）的结果与内部LC-MS/MS的结果存在可接受的中位偏差。自动化系统和免疫测定之间的中位偏倚仅适用于25-OH维生素D3（6.6%）。所有用户都表示，他们对全自动LC-MS/MS系统有很好的体验。结论全自动LC-MS/MS可以在商业实验室中轻松地集成用于常规诊断。

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Automated LC-MS/MS: Ready for the clinical routine Laboratory?

Background

Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is a sensitive method with high specificity. However, its routine use in the clinical laboratory is hampered by its high complexity and lack of automation. Studies demonstrate excellent analytical performance using the first fully automated LC-MS/MS for 25-hydroxy vitamin D and immunosuppressant drugs (ISD) in hospital routine laboratories.

Objectives

Our objectives were (1) to verify the suitability of an automated LC-MS/MS in a commercial laboratory, which differs from the needs of hospital laboratories, and (2) examine its usability among operators with various professional backgrounds.

Methods

We assessed the analytical assay performance for vitamin D and the ISDs cyclosporine A and tacrolimus over five months. The assays were compared to an identical analyzer in a hospital laboratory, to in-house LC-MS/MS methods, and to chemiluminescent microparticle immunoassays (CMIA). Nine operators evaluated the usability of the fully automated LC-MS/MS system by means of a structured questionnaire.

Results

The automated system exhibited a high precision (CV < 8%), accuracy (bias < 7%) and good agreement with concentrations of external quality assessment (EQA) samples. Comparable results were obtained with an identical analyzer in a hospital routine laboratory. Acceptable median deviations of results versus an in-house LC-MS/MS were observed for 25-OH vitamin D3 (-10.6%), cyclosporine A (-4.3%) and tacrolimus (-6.6%). The median bias between the automated system and immunoassays was only acceptable for 25-OH vitamin D3 (6.6%). All users stated that they had had a good experience with the fully automated LC-MS/MS system.