Department of Genome Medical Sciences Project, Research Institute, National Center for Global Health and Medicine, 1-7-1, Kohnodai, Ichikawa, Chiba, 272-8516, Japan.
Department of Gastroenterology, Internal Medicine, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.
J Gastroenterol. 2023 Dec;58(12):1252-1260. doi: 10.1007/s00535-023-02043-1. Epub 2023 Oct 8.
This study aimed to evaluate the quantitative measurement of Mac-2 binding protein glycosylation isomer (M2BPGi) levels using the new chemiluminescent enzyme immunoassay.
The data of a total of 347 patients with hepatitis C virus (HCV) infection and 150 health volunteers from 13 locations in Japan were evaluated. The quantitative system for measuring M2BPGi-Qt levels was based on a new chemiluminescent enzyme immunoassay. We evaluated the reproducibility and quantitation range in quantitative M2BPGi-Qt measurement. We also investigated the confidence ratio of M2BPGi-Qt levels measured by the new quantitative system to M2BPGi levels measured by the current semi-quantitative system for validating the clinical utility of the new method.
The reproducibility of M2BPGi-Qt in HCV samples with negative, positive 1+, and positive 2+ was 0.77 ± 0.02 AU/mL, 2.25 ± 0.03 AU/mL, and 6.55 ± 0.21 AU/mL, respectively, and the corresponding coefficient of variation (CV)s were 2.1%, 1.3%, and 3.2%, respectively. The range of quantification assessment resulted that all CVs showed less than 5% in investigated range. Sample stability testing found that the mean percentage difference between the pre- and post-storage values of 6 samples ranged between 96.2 and 103.9%. The correlation coefficient between M2BPGi and M2BPGi-Qt in patients with HCV and the healthy volunteers was 0.986 and 0.991, respectively. M2BPGi-Qt could be quantitatively assessed in a patient with over 20 C.O.I.
Compared with qualitative methods, the M2BPGi quantitative measurement system could provide a numerical value unaffected by interpretation bias, and measurements are more precise at high M2BPGi levels.
本研究旨在评估新型化学发光酶免疫分析法定量检测 Mac-2 结合蛋白糖基化异构体（M2BPGi）水平。
共评估了来自日本 13 个地点的 347 例丙型肝炎病毒（HCV）感染患者和 150 名健康志愿者的数据。M2BPGi-Qt 水平的定量系统基于新型化学发光酶免疫分析法。我们评估了定量 M2BPGi-Qt 测量中的重现性和定量范围。我们还研究了新定量系统测量的 M2BPGi-Qt 水平与当前半定量系统测量的 M2BPGi 水平之间的置信比，以验证新方法的临床实用性。
在 HCV 样本中，M2BPGi-Qt 的阴性、阳性 1+和阳性 2+的重现性分别为 0.77±0.02 AU/mL、2.25±0.03 AU/mL 和 6.55±0.21 AU/mL，相应的变异系数（CV）分别为 2.1%、1.3%和 3.2%。定量评估范围表明，在研究范围内，所有 CV 均小于 5%。样本稳定性测试发现，6 个样本的预存值和存储后值之间的平均百分比差异在 96.2%至 103.9%之间。HCV 患者和健康志愿者的 M2BPGi 和 M2BPGi-Qt 之间的相关系数分别为 0.986 和 0.991。M2BPGi-Qt 可在超过 20 个 C.O.I.的患者中进行定量评估。
与定性方法相比，M2BPGi 定量测量系统可提供不受解释偏差影响的数值，并且在 M2BPGi 水平较高时测量更为精确。
