Junger Sina, Hoene Miriam, Shipkova Maria, Danzl Gudrun, Schöberl Christof, Peter Andreas, Lehmann Rainer, Wieland Eberhard, Braitmaier Helmine
SYNLAB MVZ Leinfelden-Echterdingen GmbH, Leinfelden-Echterdingen, Germany.
Institute for Clinical Chemistry and Pathobiochemistry, Department for Diagnostic Laboratory Medicine, University Hospital Tübingen, Tübingen, Germany.
J Mass Spectrom Adv Clin Lab. 2023 Aug 2;30:1-9. doi: 10.1016/j.jmsacl.2023.07.001. eCollection 2023 Nov.
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.
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.
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.
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.
A fully automated LC-MS/MS can be easily integrated for routine diagnostics in a commercial laboratory.
液相色谱 - 串联质谱法（LC-MS/MS）是一种具有高特异性的灵敏方法。然而，其在临床实验室的常规应用因高度复杂性和缺乏自动化而受到阻碍。研究表明，在医院常规实验室中，首台用于25-羟基维生素D和免疫抑制剂药物（ISD）分析的全自动LC-MS/MS展现出卓越的分析性能。
我们的目标是（1）验证全自动LC-MS/MS在商业实验室中的适用性，商业实验室的需求与医院实验室不同；（2）考察其在具有不同专业背景的操作人员中的易用性。
我们在五个月的时间里评估了维生素D以及免疫抑制剂环孢素A和他克莫司的分析测定性能。将这些测定结果与医院实验室中相同的分析仪、内部LC-MS/MS方法以及化学发光微粒子免疫分析法（CMIA）进行比较。九名操作人员通过结构化问卷对全自动LC-MS/MS系统的易用性进行了评估。
该自动化系统具有高精度（CV < 8%）、高准确度（偏差 < 7%），并且与外部质量评估（EQA）样本的浓度具有良好的一致性。在医院常规实验室中使用相同的分析仪也获得了类似的结果。观察到25-羟基维生素D3（-10.6%）、环孢素A（-4.3%）和他克莫司（-6.6%）与内部LC-MS/MS结果的可接受中位数偏差。自动化系统与免疫分析法之间的中位数偏差仅在25-羟基维生素D3（6.6%）时可接受。所有用户均表示他们在使用全自动LC-MS/MS系统时体验良好。
全自动LC-MS/MS能够轻松整合到商业实验室的常规诊断中。
