Department of Laboratory Medicine, Health Promotion Research Institute, Korea Association of Health Promotion, Seoul, Korea.
MEDIcheck LAB, Korea Association of Health Promotion, Cheongju, Korea.
J Clin Lab Anal. 2020 Aug;34(8):e23316. doi: 10.1002/jcla.23316. Epub 2020 Mar 29.
Mild-to-moderate fibrosis is rarely diagnosed because the disease is asymptomatic in the early stage. The serum level of Mac-2 binding protein glycosylation isomer (M2BPGi) has been found to increase with the severity of liver fibrosis. The aim of this study was to determine the diagnostic performance of M2BPGi in screening liver fibrosis using magnetic resonance elastography (MRE) as a reference standard and to compare it with using the aspartate aminotransferase-to-platelet ratio (APRI) and the Fibrosis-4 index (FIB-4) in health checkups.
This cross-sectional study consecutively selected subjects at health examinations who underwent MRE and M2BPGi testing at eight health promotion centers in Korea between January and September 2019. The serum M2BPGi level was measured using the chemiluminescence enzyme immunoassay method. The measured levels were indexed using the cutoff index (COI). COI values of M2BPGi were compared with the MRE results.
The median (interquartile) values of COI for fibrosis stages F0 (normal liver stiffness), F1 (mild fibrosis), F2 (significant fibrosis), and ≥F3 (advanced fibrosis) were 0.49 (0.34-0.61), 0.48 (0.38-0.68), 0.64 (0.43-1.03), and 1.01 (0.75-1.77), respectively (P < .0001). The AUCs of the COI for the screening of fibrosis stage ≥F1, ≥F2, and ≥F3 were 0.591, 0.698, and 0.853, respectively. Using a threshold of 0.75 for COI to exclude advanced fibrosis had a sensitivity, specificity, and negative predictive value of 80.0%, 77.9%, and 98.9%, respectively. The AUC for excluding advanced fibrosis was better for M2BPGi than for FIB-4 and APRI.
Serum M2BPGi was useful for screening significant and advanced fibrosis in health checkups.
轻度至中度纤维化很少被诊断出来，因为在疾病早期阶段没有症状。已经发现，肝纤维化严重程度与 Mac-2 结合蛋白糖基化异构体（M2BPGi）的血清水平升高有关。本研究旨在确定 M2BPGi 通过磁共振弹性成像（MRE）作为参考标准筛查肝纤维化的诊断性能，并将其与在健康检查中使用天冬氨酸氨基转移酶与血小板比值（APRI）和纤维化 4 指数（FIB-4）进行比较。
这是一项横断面研究，连续选择了 2019 年 1 月至 9 月在韩国的八个健康促进中心进行 MRE 和 M2BPGi 检测的健康检查受试者。使用化学发光酶免疫测定法测量血清 M2BPGi 水平。使用截断指数（COI）对测量值进行索引。将 M2BPGi 的 COI 值与 MRE 结果进行比较。
COI 的纤维化分期 F0（正常肝硬度）、F1（轻度纤维化）、F2（显著纤维化）和≥F3（晚期纤维化）的中位数（四分位距）分别为 0.49（0.34-0.61）、0.48（0.38-0.68）、0.64（0.43-1.03）和 1.01（0.75-1.77）（P<0.0001）。COI 筛查纤维化分期≥F1、≥F2 和≥F3 的 AUC 分别为 0.591、0.698 和 0.853。使用 COI 截断值为 0.75 排除晚期纤维化的敏感性、特异性和阴性预测值分别为 80.0%、77.9%和 98.9%。排除晚期纤维化的 AUC 对 M2BPGi 优于 FIB-4 和 APRI。
血清 M2BPGi 可用于健康检查中筛选显著和晚期纤维化。
