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.

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, reprod

SUBMITTER: Xie G 

PROVIDER: S-EPMC11788763 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature