Evaluation of the Serum Mac-2 Binding Protein Glycosylation Isomer Test used for Diagnosis and Monitoring of Liver Fibrosis and the Correlation of Mac-2 Binding Protein Glycosylation Isomer with Hemoglobin A1c.

BACKGROUND: Our aims in this study were to evaluate the performance of the Mac-2 binding protein glycosylation isomer (M2BPGi), a liver fibrosis marker, using Sysmex HISCL following user verification guidelines before clinical use. We also evaluated the correlation between M2BPGi and hemoglobin A1c (HbA1c) because HbA1c is known as another biomarker associated with glycosylation.
METHODS: The analytical performance of M2BPGi was verified following user verification guidelines by the Clinical and Laboratory Standards Institute.
RESULTS: A qualitative, precision experiment for analyte concentrations near the cutoff was verified using quality control materials. The manufacturer's precision claims for the quantitative cutoff index were verified, with coefficients of variation in the range of 1.83 - 4.12%. HbA1c did not significantly contribute to M2BPGi in a multivariate analysis with an age factor.
CONCLUSIONS: The analytical performance of M2BPGi in our results verify the manufacturer's claims. Clinical information and other findings, including HbA1c, are needed for clinical applications.