LecT-Hepa: A triplex lectin–antibody sandwich immunoassay for estimating the progression dynamics of liver fibrosis assisted by a bedside clinical chemistry analyzer and an automated pretreatment machine

Abstract

BackgroundA quantitative analysis of glyco-alteration in serum glycoproteins provides glyco-parameters for estimating the progression of liver fibrosis. In the analysis of glycans, a manual pretreatment process for clinical specimens leads to a complicated manipulation and loss-of-clinical implementation of the assay. MethodWe evaluated an automated triplex lectin–antibody sandwich immunoassay assisted by an automated protein purification system (ED-01) and a bedside clinical chemistry analyzer (HISCL) for the acquisition of two glyco-parameters (AOL/DSA and MAL/DSA) derived from a fibrosis-related glyco-alteration of serum alpha1-acid glycoprotein (AGP). ResultsWe adjusted the auto-machines with their accuracy set to CV <5.0% (ED-01) and <1.0% (HISCL). AGP samples were enriched from 275 serum specimens. Two glyco-parameters obtained by HISCL showed a linear correlation with that from a reported assay (R>0.90). The formula for monitoring fibrosis (LecT-Hepa) was given by a combination of the glyco-parameters. This correlated with the fibrosis stage from biopsy (R=0.68) and diagnosed severe fibrosis and cirrhosis. It was superior to that of FIB-4 index. ConclusionsWe automated a multilectin-assisted immunoassay with an order of magnitude reduction of operation time without any loss-of-accuracy. LecT-Hepa is a reliable method to assess fibrosis-dynamics from moderate fibrosis to cirrhosis.