Lumipulse HBsAg-HQ对HBsAg的性能评估：建筑师HBsAg-QT与HBsAg的一致

StephenW

Adv Clin Exp Med. 2018 Jun 8. doi: 10.17219/acem/69247. [Epub ahead of print]
Performance evaluation of HBsAg by Lumipulse HBsAg-HQ: The agreement with HBsAg by Architect HBsAg-QT and the effectiveness in predicting liver tissue pathological states of chronic hepatitis B patients.
Zhang Z1, Ding R1, Lu W1, Yang Z2, Wang Y1, Zhou X1, Huang D1, Li X1, Feng Y1.
Author information

1
    Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.
2
    Fujirebio Shanghai Representative Office, Shanghai, China.

Abstract
BACKGROUND:

A novel high-sensitivity HBsAg quantification assay, Lumipulse HBsAg-HQ, was developed. However, its performance in practical application has not yet been adequately investigated.
OBJECTIVES:

The aim of the study was to evaluate the agreement of serum HBsAg by Lumipulse HBsAg-HQ (HBsAg-HQ) with HBsAg by Architect HBsAg-QT (HBsAg-QT) and comparatively investigate the efficacy of serum HBsAg-HQ and HBsAg-QT in predicting the liver tissue pathological states of chronic hepatitis B (CHB) patients.
MATERIAL AND METHODS:

A total of 147 HBeAg-positive and 128 HBeAg-negative patients were enrolled. HBsAg-HQ and HBsAg-QT were measured using CLEIA Lumipulse G1200 and CMIA Abbott Architect I2000 automatic analyzer, respectively. The Scheuer standard was used for the pathological diagnosis of liver tissue samples.
RESULTS:

In both HBeAg-positive and HBeAg-negative patients, HBsAg-HQ was significantly positively correlated with HBsAg-QT (r = 0.913 and r = 0.959, respectively), the overall disagreement rates between HBsAg-HQ and HBsAg-QT were 2.72% (4/147) and 4.69% (6/128), respectively. In HBeAg-positive patients, the area under the ROC curve (AUC) of HBsAg-HQ and HBsAg-QT for predicting the grade ≥G3 (0.686 and 0.684, respectively) and stage ≥S4 (0.739 and 0.745, respectively) were the greatest compared with other pathological states; the optimal cutoffs of HBsAg-HQ and HBsAg-QT for predicting the grade ≥G3 were <2.244 × 107 mIU/mL and <3.589 × 107 mIU/mL, and those for predicting the stage ≥S4 were 7.328 × 106 mIU/mL and <6.194 × 106 mIU/mL, respectively.
CONCLUSIONS:

HBsAg-HQ is highly correlated and in agreement with HBsAg-QT in both HBeAg-positive and HBeAg-negative patients; HBsAg-HQ and HBsAg-QT are very valuable in predicting the grade ≥G3 and stage ≥S4 in HBeAg-positive patients.
KEYWORDS:

Lumipulse HBsAg-HQ; hepatitis B surface antigen; noninvasive diagnosis; pathology; performance evaluation

PMID:
    29893514
DOI:
    10.17219/acem/69247

StephenW

Adv Clin Exp Med。 2018年6月8日doi：10.17219 / acem / 69247。 [电子版提前打印]
Lumipulse HBsAg-HQ对HBsAg的性能评估：建筑师HBsAg-QT与HBsAg的一致性和慢性乙型肝炎患者肝组织病理状态预测的有效性。
张Z1，丁R1，陆W1，杨Z2，王Y1，周X1，黄D1，李X1，冯Y1。
作者信息

1
    复旦大学上海公共卫生临床中心，中国上海。
2
    Fujirebio上海代表处，中国上海。

抽象
背景：

开发了一种新型高灵敏度HBsAg定量检测试剂Lumipulse HBsAg-HQ。但是，它在实际应用中的表现还没有得到充分的调查。
目的：

本研究的目的是评估Lumipulse HBsAg-HQ（HBsAg-HQ）和HBsAg构建者HBsAg-QT（HBsAg-QT）检测血清HBsAg的一致性，并比较HBsAg-HQ和HBsAg-QT的血清HBsAg-预测慢性乙型肝炎（CHB）患者的肝组织病理状态。
材料与方法：

共招募了147例HBeAg阳性和128例HBeAg阴性患者。使用CLEIA Lumipulse G1200和CMIA Abbott Architect I2000自动分析仪分别测量HBsAg-HQ和HBsAg-QT。 Scheuer标准被用于肝组织样品的病理诊断。
结果：

在HBeAg阳性和HBeAg阴性患者中，HBsAg-HQ与HBsAg-QT显着正相关（分别为r = 0.913和r = 0.959），HBsAg-HQ和HBsAg-QT总体不一致率分别为2.72％（ 4/147）和4.69％（6/128）。在HBeAg阳性患者中，预测≥G3（分别为0.686和0.684）和≥S4（分别为0.739和0.745）的HBsAg-HQ和HBsAg-QT的ROC曲线下面积（AUC）最大与其他病理状态比较; HBsAg-HQ和HBsAg-QT预测≥G3级的最佳截断值分别为<2.244×107 mIU / mL和<3.589×107 mIU / mL，预测≥S4期的最佳截断值分别为7.328×106 mIU / mL和<6.194×106 mIU / mL。
结论：

在HBeAg阳性和HBeAg阴性患者中，HBsAg-HQ与HBsAg-QT高度相关并且一致; HBsAg-HQ和HBsAg-QT对于预测HBeAg阳性患者的≥G3级和≥S4级非常有价值。
关键词：

Lumipulse HBsAg-HQ;乙型肝炎表面抗原;无创诊断;病理;绩效评估

结论：
    29893514
DOI：
    10.17219 / ACEM / 69247

Hepbest

结论：
在HBeAg阳性和HBeAg阴性患者中，HBsAg-HQ与HBsAg-QT高度相关并且一致; HBsAg-HQ和HBsAg-QT对于预测HBeAg阳性患者的≥G3级和≥S4级非常有价值。

这是不是意味着，以后这种方法，可以替代肝穿啦

齐欢畅

马克