Validation of a LC-MS/MS assay for citric acid, cysteine and oxalic acid determination and its application to explore pre-analytical sample storage

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY Practical Laboratory Medicine Pub Date : 2024-09-30 DOI:10.1016/j.plabm.2024.e00433

Ying Shen , Xia Luo , Qing Guan , Wenjie Lou , Liming Cheng

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Abstract

Objectives

Citrate, oxalate and cystine in 24-h urine are considered to be associated with the incidence and recurrence risk of urinary stone disease (USD). An evaluation of the LC-MS/MS kit for simultaneous quantification of the three analytes was undertaken.

Design

& Methods: The analytical performance of the kit was investigated based on FDA, EMA and CLSI guidelines. To promote the standardization of sample storage, this kit has been applied to perform systematic pre-analytical stability study of these analytes in urine.

Results

This method was validated with good linearity with accuracy of 93.1%–104 %. Intra-day and inter-day imprecision were ≤5.55 % and 5.34 %, respectively. Recoveries of citrate, oxalate and cystine added to clinical samples were in the range of 92.0–103 %, 94.8–100 % and 99.0–107 % with CV ≤ 5.52 %. It was recommended that urine preserved with hydrochloric acid could be preferable in consideration of both reliable test results and neglected sample heterogeneity.

Conclusions

This kit is suitable for measurement of citrate, oxalate and cystine for understanding the etiology of urinary stones, and the proper storage of urine samples is crucial for the correctness of the test results.

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验证测定柠檬酸、半胱氨酸和草酸的 LC-MS/MS 分析法及其在探索分析前样品储存中的应用

目的 24 小时尿液中的柠檬酸盐、草酸盐和胱氨酸被认为与尿石症（USD）的发病率和复发风险有关。我们对 LC-MS/MS 试剂盒进行了评估，以同时定量分析这三种分析物：根据 FDA、EMA 和 CLSI 指南对试剂盒的分析性能进行了调查。结果：该方法线性关系良好，准确度为 93.1%-104%。日内和日间误差分别小于5.55%和5.34%。临床样本中柠檬酸盐、草酸盐和胱氨酸的回收率分别为 92.0%-103%、94.8%-100% 和 99.0%-107%，CV ≤ 5.52%。结论：该试剂盒适用于测定枸橼酸盐、草酸盐和胱氨酸，可用于了解尿路结石的病因，尿样的妥善保存对检测结果的正确性至关重要。

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来源期刊

Practical Laboratory Medicine Health Professions-Radiological and Ultrasound Technology

CiteScore

3.50

自引率

0.00%

发文量

审稿时长

7 weeks

期刊介绍： Practical Laboratory Medicine is a high-quality, peer-reviewed, international open-access journal publishing original research, new methods and critical evaluations, case reports and short papers in the fields of clinical chemistry and laboratory medicine. The objective of the journal is to provide practical information of immediate relevance to workers in clinical laboratories. The primary scope of the journal covers clinical chemistry, hematology, molecular biology and genetics relevant to laboratory medicine, microbiology, immunology, therapeutic drug monitoring and toxicology, laboratory management and informatics. We welcome papers which describe critical evaluations of biomarkers and their role in the diagnosis and treatment of clinically significant disease, validation of commercial and in-house IVD methods, method comparisons, interference reports, the development of new reagents and reference materials, reference range studies and regulatory compliance reports. Manuscripts describing the development of new methods applicable to laboratory medicine (including point-of-care testing) are particularly encouraged, even if preliminary or small scale.