Analytical validation of a LC-MS/MS based in vitro diagnostic kit for the quantification of L-tyrosine and taurocholic acid for liver fibrosis diagnosis

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY Practical Laboratory Medicine Pub Date : 2025-01-16 DOI:10.1016/j.plabm.2025.e00454

Guoxiang Xie , Kejun Zhou , Wenting Sun , Fengjie Huang , Lu Wang , Zhangbao Zhou , Wei Jia

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引用次数: 0

Abstract

Background

FibraChek is a newly developed mass spectrometry (MS) assay kit approved by the National Medical Products Administration (NMPA) of China for quantifying L-tyrosine (Tyr) and taurocholic acid (TCA) in serum, aiding liver fibrosis diagnosis. This study aimed to assess its analytical performance.

Methods

The analytical performance was investigated based on NMPA and CLSI guidelines. Method suitability in the clinical context was tested by analyzing clinical samples from liver fibrosis patients confirmed via liver biopsy.

Results

The assay enables simultaneous determination of Tyr and TCA, demonstrating compliance with performance parameters such as linearity, dynamic range, limit of detection (LOD), limit of quantification (LOQ), recovery, repeatability, reproducibility, and stability. It validated a linear range of 20–1000 μmol/L for Tyr and 10.3–618 ng/ml for TCA, maintaining stability after 5 freeze-thaw cycles for 14 months. Components remained stable for up to 7 days at room temperature and 30 days at 2–8 °C. TCA and Tyr were stable for up to 36 months at −20 °C or −80 °C. The method effectively quantified Tyr and TCA in serum from liver fibrosis patients and healthy controls.

Conclusions

This is the first MS-based assay for non-invasive liver fibrosis detection validated for clinical use, providing a rapid and reliable analytical protocol suitable for routine analysis.

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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.