Easy CutaMiNi TRFIA与Architect I2000 CMIA血清HBsAg定量预测慢性乙型肝炎肝组织病理状态的一致性

摘要/Abstract

摘要： 目的探讨Easy CutaMiNi TRFIA血清HBsAg(HBsAg-TRFIA)与Architect I2000 CMIA血清HBsAg(HBsAg-CMIA)定量检测结果及其预测慢性乙型肝炎肝组织病理状态性能的一致性。方法 164例HBeAg阳性和132例HBeAg阴性慢性乙型肝炎患者入选本研究。所有入选者均经肝活组织检查,肝组织病理学诊断采用Scheuer评分系统。结果无论HBeAg阳性或阴性患者,HBsAg-TRFIA与HBsAg-CMIA均呈显著正相关(r＝0.939,P<0.01和r＝0.952,P<0.01)并且有紧密的线性关系(F＝2973.419, P< 0.01和F＝1246.786, P<0.01)。HBeAg阳性患者,HBsAg-TRFIA和HBsAg-CMIA预测炎症活动度≥G2、≥G3的ROC曲线下面积分别为0.624(95% CI: 0.539～0.710)、0.671(95% CI: 0.578～0.764)和0.644(95% CI: 0.559～0.728)、0.672(95% CI: 0.577～0.768);预测纤维化分期≥S2、≥S3、≥S4的ROC曲线下面积分别为0.652(95% CI: 0.566～0.738)、0.715(95% CI: 0.631～0.799)、0.775(95% CI: 0.692～0.857)和0.665(95% CI: 0.580～0.750)、0.724(95% CI: 0.642～0.807)、0.781(95% CI: 0.695%～0.866)。HBeAg阴性患者,HBsAg-TRFIA和HBsAg-CMIA预测炎症活动度≥G2、≥G3的ROC曲线下面积分别为0.555(95% CI: 0.452～0.657)、0.581(95% CI: 0.454～0.707)和0.549(95% CI: 0.444～0.654)、0.567(95% CI: 0.433～0.701);预测纤维化分期≥S2,≥S3、≥S4的ROC曲线下面积分别为0.525(95% CI: 0.424～0.626)、0.582(95% CI: 0.481～0.683)、0.566(95% CI: 0.440～0.692)和0.536(95% CI: 0.436～0.636)、0.598(95% CI: 0.495%～0.700)、0.553(95% CI: 0.420～0.686)。无论HBeAg阳性或阴性患者,HBsAg-TRFIA与HBsAg-CMIA预测炎症活动度≥G2、≥G3和纤维化分期≥S2、≥S3、≥S4的ROC曲线下面积之间的差异均无统计学意义(P＞0.05)。结论 HBsAg-TRFIA与HBsAg-CMIA定量检测结果及其预测慢性乙型肝炎肝组织不同病理状态的效能保持高度一致。

关键词: 时间分辨荧光免疫分析, 化学发光微粒子免疫分析, 慢性乙型肝炎, 病理学, 无创诊断

Abstract: Objective To investigate quantitative serum hepatitis B surface antigen (HBsAg) detection using Easy CutaMiNi TRFIA (HBsAg-TRFIA) and Architect I2000 CMIA (HBsAg-CMIA), and to analyze their consistency in predicting liver histopathology in chronic hepatitis B (CHB) patients.Methods One hundred and sixty-four HBeAg-positive and 132 HBeAg-negative CHB patients with liver biopsy were enrolled in the study. Scheuer scoring system was applied in liver histopathological diagnosis.Results HBsAg-TRFIA was significantly positively linearly correlated with HBsAg-CMIA in HBeAg positive(r=0.939, F=2973.419, P<0.0001) and negative patients (r=0.952, F=1246.786, P<0.0001), respectively. Moreover, in HBeAg-positive patients, the areas under the receiver operating characteristic curve (AUROC) of HBsAg-TRFIA and HBsAg-CMIA for predicting ≥ G2 and ≥ G3 were 0.624 (95% CI: 0.539~0.710), 0.671 (95% CI: 0.578~0.764) and 0.644 (95% CI: 0.559~0.728), 0.672 (95% CI: 0.577~0.768), respectively. The AUROC of HBsAg-TRFIA and HBsAg-CMIA for predicting ≥ S2, ≥ S3 and ≥ S4 were 0.652 (95% CI: 0.566~0.738), 0.715 (95% CI: 0.631~0.799), 0.775 (95% CI: 0.692~0.857) and 0.665 (95% CI: 0.580~0.750), 0.724 (95% CI: 0.642~0.807), 0.781 (95% CI: 0.695~0.866), respectively. In HBeAg-negative patients, the AUROC curves of HBsAg-TRFIA and HBsAg-CMIA for predicting ≥ G2 and ≥ G3 were 0.555 (95% CI: 0.452~0.657), 0.581 (95% CI: 0.454~0.707) and 0.549 (95% CI: 0.444~0.654), 0.567 (95% CI: 0.433~0.701), respectively. The AUROC of HBsAg-TRFIA and HBsAg-CMIA for predicting ≥ S2, ≥ S3 and ≥ S4 were 0.525 (95% CI: 0.424~0.626), 0.582 (95% CI: 0.481~0.683), 0.566 (95% CI: 0.440~0.692) and 0.536 (95% CI: 0.436~0.636), 0.598 (95% CI: 0.495~0.700), 0.553 (95% CI: 0.420~0.686), respectively. In both HBeAg positive and negative patients, there were no significant differences between HBsAg-TRFIA and HBsAg-CMIA for predicting the pathological grade ≥ G2, ≥ G3 and stage ≥ S2, ≥ S3, ≥ S4.Conclusion There was highly consistency between HBsAg-TRFIA and HBsAg-CMIA in accuracy for measurement of HBsAg, as well as prediction of liver histopathology in CHB patients.

Key words: Time-resolved fluoroimmunoassay, Chemiluminescence microparticle immunoassay, Chronic hepatitis B, Pathlogy, Noninvasive diagnosis

张正华,金红弟,陆伟,田海兵,汤伟民,张占卿. Easy CutaMiNi TRFIA与Architect I2000 CMIA血清HBsAg定量预测慢性乙型肝炎肝组织病理状态的一致性[J]. 肝脏, 2017, 22(11): 998-1004.

ZHANG Zheng-hua, JIN Hong-di, LU Wei, TIAN Hai-bing, TANG Wei-min, ZHANG Zhan-qing. Infectology Department of Guhua Hospital, Fengxian, Shanghai 201499; Division Two of hepatology Department, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China. Serum HBsAg quantitation using Easy CutaMiNi TRFIA and Architect I2000 CMIA and the consistency analysis in predicting liver histopathology in chronic hepatitis B patients[J]. Chinese Hepatolgy, 2017, 22(11): 998-1004.

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