Lumipulse HBsAg-HQ与Architect HBsAg-QT定量的一致性及其预测慢性乙型肝炎肝组织病理状态的效能

doi:10.3877/cma.j.issn.1674-1358.2017.05.005

目的

探讨血清Lumipulse HBsAg-HQ与Architect HBsAg-QT定量的一致性及其预测慢性乙型肝炎肝组织病理状态的效能。

方法

选取147例HBeAg阳性和128例HBeAg阴性患者。HBsAg-HQ采用化学发光酶免疫法和Fujirebio Lumipulse G1200全自动化学发光免疫系统检测，HBsAg-QT采用化学发光微粒子免疫法和Abbott Architect I 2000全自动化学发光免疫系统检测。肝组织病理学诊断采用Scheuer评分系统。数据处理和统计分析Medcalc 15.1软件。

结果

血清HBsAg-QT < 100 000 mIU/ml患者，血清HBsAg-HQ与HBsAg-QT呈显著正相关（r = 0.861，P < 0.001），血清HBsAg-HQ与HBsAg-QT总体不一致率为6.45%（2/31）；血清HBsAg-QT ≥ 100 000 mIU/ml患者，血清HBsAg-HQ与HBsAg-QT呈显著正相关（r = 0.929，P < 0.001），血清HBsAg-HQ与HBsAg-QT总体不一致率为0.25%（6/244）。HBeAg阳性患者，血清HBsAg-HQ和HBsAg-QT预测病理学分级≥ G2、≥ G3和分期≥ S2、≥ S3、≥ S4的ROC曲线下面积与对角参考下面积之间的差异均具有统计学意义（P均< 0.05），其中预测病理学分期≥ S4的ROC曲线下面积最大；血清HBsAg-HQ与HBsAg-QT预测肝组织相同病理状态的ROC曲线下面积间差异均无统计学意义（P均> 0.05）；血清HBsAg-HQ和HBsAg-QT预测病理学分期≥ S4的最佳截断值分别为7.328 × 10⁶ mIU/ml和6.194 × 10⁶ mIU/ml，其对应的灵敏度、特异度分别为81.25%和75.00%、64.35%和67.83%。

结论

血清HBsAg-HQ与HBsAg-QT有高度的相关性和一致性，血清HBsAg-HQ和HBsAg-QT对HBeAg阳性患者病理学分期≥ S4有一定预测意义。

关键词: 乙型肝炎表面抗原, 全自动化学发光免疫系统, 肝组织, 病理学, 无创诊断

Objective

To investigate the consistency between quantitative Lumipulse HBsAg-HQ and Architect HBsAg-QT, and their predictive efficacy on liver tissue pathological state of chronic hepatitis B.

Methods

Total of 147 patients with HBeAg-positive and 128 patients with HBeAg-negative were enrolled, respectively. Serum HBsAg-HQ was measured by chemiluminescence enzyme immunoassay and Lumipulse G1200 automatic chemiluminescence immunoassay analyzer, while serum HBsAg-QT was measured by chemiluminescence microparticle immunoassay and Abbott Architect I 2000 automatic chemiluminescence immunoassay analyzer. The Scheuer score system was used for pathological diagnosis of liver tissue. Medcalc software 15.1 was used for data processing and statistical analysis.

Results

Among the patients with serum HBsAg-QT less than 100 000 mIU/ml, serum HBsAg-HQ was positively correlated significantly with HBsAg-QT (r = 0.861, P < 0.001), and the overall disagreement rate between quantitative HBsAg-HQ and HBsAg-QT was 6.45% (2/31). Among the patients with serum HBsAg-QT more than or equal to 100 000 mIU/ml, serum HBsAg-HQ was positively correlated significantly with HBsAg-QT (r = 0.929, P < 0.001), and the overall disagreement rate between quantitative HBsAg-HQ and HBsAg-QT was 0.25% (6/244). Among the patients with HBeAg-positive, the areas under ROC of serum HBsAg-HQ and HBsAg-QT for predicting ≥ G2, ≥ G3 of pathological grade and ≥ S2, ≥ S3, ≥ S4 of pathological stage were significantly larger than the area under diagonal reference (all P < 0.05), in which the area under ROC of serum HBsAg-HQ and HBsAg-QT for predicting ≥ S4 was the largest. The differences between the area under ROC of serum HBsAg-HQ and HBsAg-QT for predicting the same pathological states were not significantly different. The optimal cutoffs of serum HBsAg-HQ and HBsAg-QT for predicting ≥ S4 were 7.328 × 10⁶ mIU/ml and 6.194 × 10⁶ mIU/ml, and the corresponding sensitivity and specificity were 81.25% and 64.35%, 75% and 67.83%, respectively.

Conclusions

The quantitative serum HBsAg-HQ was highly correlated and consistent with HBsAg-QT. Serum HBsAg-HQ and HBsAg-QT were of predictive value for ≥ S4 of pathological stage in patients with HBeAg-positive.

Key words: Hepatitis B surface antigen, Automatic chemiluminescence immunoassay analyzer, Liver tissue, Pathology, Noninvasive diagnosis

表1 血清HBsAg-HQ与HBsAg-QT水平的分组分布（ ± s，log₁₀mIU/ml）

组别	例数	HBsAg-HQ	HBsAg-QT	t值	P值
HBeAg阳性	147	6.932 ± 0.764	6.915 ± 0.856	0.185	0.853
HBeAg阴性	128	5.830 ± 0.930	5.773 ± 1.053	0.459	0.647
HBsAg-QT< 5 log₁₀mIU/ml	31	4.564 ± 0.823	4.206 ± 0.806	1.732	0.089
HBsAg-QT≥ 5 log₁₀mIU/ml	244	6.655 ± 0.752	6.660 ± 0.790	0.072	0.942
合计	275	6.419 ± 1.007	6.383 ± 1.109	0.397	0.691

表1 血清HBsAg-HQ与HBsAg-QT水平的分组分布（ ± s，log₁₀mIU/ml）

组别	例数	HBsAg-HQ	HBsAg-QT	t值	P值
HBeAg阳性	147	6.932 ± 0.764	6.915 ± 0.856	0.185	0.853
HBeAg阴性	128	5.830 ± 0.930	5.773 ± 1.053	0.459	0.647
HBsAg-QT< 5 log₁₀mIU/ml	31	4.564 ± 0.823	4.206 ± 0.806	1.732	0.089
HBsAg-QT≥ 5 log₁₀mIU/ml	244	6.655 ± 0.752	6.660 ± 0.790	0.072	0.942
合计	275	6.419 ± 1.007	6.383 ± 1.109	0.397	0.691

图1 血清HBsAg-HQ与HBsAg-QT的相关性和一致性

表2 血清HBsAg-HQ与HBsAg-QT水平的Pearson相关系数和Bland-Altman一致性分析

组别	例数	r值	P值	偏倚	95%LOA	不一致率（%）
组别	例数	r值	P值	偏倚	95%LOA	≤ 95%LOA下限	≥ 95%LOA上限	合计
HBeAg阳性	147	0.913	< 0.001	0.02	-0.67～0.70	2/147（0.68）	3/147（2.04）	4/147（2.72）
HBeAg阴性	128	0.959	< 0.001	0.06	-0.55～0.66	1/128（0.78）	5/128（3.91）	6/128（4.69）
HBsAg-QT<5 log₁₀mIU/ml	31	0.861	< 0.001	0.36	-0.49～1.20	0/31（0.00）	2/31（6.45）	2/31（6.45）
HBsAg-QT≥ 5 log₁₀mIU/ml	244	0.929	< 0.001	-0.01	-0.58～0.57	2/244（0.82）	4/244（0.16）	6/244（0.25）
合计	275	0.955	< 0.001	0.04	-0.61～0.69	2/275（0.73）	8/275（2.91）	10/275（3.64）

表2 血清HBsAg-HQ与HBsAg-QT水平的Pearson相关系数和Bland-Altman一致性分析

组别	例数	r值	P值	偏倚	95%LOA	不一致率（%）
组别	例数	r值	P值	偏倚	95%LOA	≤ 95%LOA下限	≥ 95%LOA上限	合计
HBeAg阳性	147	0.913	< 0.001	0.02	-0.67～0.70	2/147（0.68）	3/147（2.04）	4/147（2.72）
HBeAg阴性	128	0.959	< 0.001	0.06	-0.55～0.66	1/128（0.78）	5/128（3.91）	6/128（4.69）
HBsAg-QT<5 log₁₀mIU/ml	31	0.861	< 0.001	0.36	-0.49～1.20	0/31（0.00）	2/31（6.45）	2/31（6.45）
HBsAg-QT≥ 5 log₁₀mIU/ml	244	0.929	< 0.001	-0.01	-0.58～0.57	2/244（0.82）	4/244（0.16）	6/244（0.25）
合计	275	0.955	< 0.001	0.04	-0.61～0.69	2/275（0.73）	8/275（2.91）	10/275（3.64）

图2 血清HBsAg-HQ和HBsAg-QT与肝组织病理学分级和分期的相关性

图3 血清HBsAg-HQ与HBsAg-QT预测HBeAg阳性患者病理学分级≥ G3和分期≥ S4的ROC曲线

表3 血清HBsAg-HQ和HBsAg-QT预测肝组织不同病理状态的ROC曲线下面积

病理状态	HBsAg	HBeAg阳性						HBeAg阴性
病理状态	HBsAg	AUC^*	SE^#	Z	P	95%CI	AUC^*	SE^#	Z	P	95%CI
≥ G2	HBsAg-HQ	0.651^a	0.046	3.290	0.001	0.568～0.727	0.573f	0.051	1.425	0.1542	0.482～0.660
	HBsAg-QT	0.670^a	0.045	3.755	< 0.001	0.588～0.745	0.547^f	0.052	0.781	0.4351	0.451～0.629
≥ G3	HBsAg-HQ	0.686^b	0.047	3.957	< 0.001	0.604～0.760	0.584^g	0.064	1.317	0.1877	0.493～0.671
	HBsAg-QT	0.684^b	0.046	4.038	< 0.001	0.602～0.758	0.558^g	0.068	0.778	0.4365	0.463～0.641
≥ S2	HBsAg-HQ	0.659^c	0.049	3.266	0.001	0.576～0.735	0.492^h	0.054	0.145	0.8848	0.402～0.582
	HBsAg-QT	0.660^c	0.050	3.213	0.001	0.577～0.736	0.514^h	0.053	0.156	0.8757	0.418～0.598
≥ S3	HBsAg-HQ	0.712^d	0.042	5.045	< 0.001	0.632～0.784	0.572ⁱ	0.052	1.391	0.1641	0.481～0.659
	HBsAg-QT	0.720^d	0.041	5.327	< 0.001	0.640～0.791	0.540ⁱ	0.053	0.645	0.5192	0.444～0.623
≥ S4	HBsAg-HQ	0.739^e	0.046	5.159	< 0.001	0.660～0.808	0.552^j	0.064	0.810	0.4177	0.461～0.640
	HBsAg-QT	0.745^e	0.045	5.476	< 0.001	0.666～0.813	0.508^j	0.065	0.058	0.9536	0.414～0.593

表3 血清HBsAg-HQ和HBsAg-QT预测肝组织不同病理状态的ROC曲线下面积

病理状态	HBsAg	HBeAg阳性						HBeAg阴性
病理状态	HBsAg	AUC^*	SE^#	Z	P	95%CI	AUC^*	SE^#	Z	P	95%CI
≥ G2	HBsAg-HQ	0.651^a	0.046	3.290	0.001	0.568～0.727	0.573f	0.051	1.425	0.1542	0.482～0.660
	HBsAg-QT	0.670^a	0.045	3.755	< 0.001	0.588～0.745	0.547^f	0.052	0.781	0.4351	0.451～0.629
≥ G3	HBsAg-HQ	0.686^b	0.047	3.957	< 0.001	0.604～0.760	0.584^g	0.064	1.317	0.1877	0.493～0.671
	HBsAg-QT	0.684^b	0.046	4.038	< 0.001	0.602～0.758	0.558^g	0.068	0.778	0.4365	0.463～0.641
≥ S2	HBsAg-HQ	0.659^c	0.049	3.266	0.001	0.576～0.735	0.492^h	0.054	0.145	0.8848	0.402～0.582
	HBsAg-QT	0.660^c	0.050	3.213	0.001	0.577～0.736	0.514^h	0.053	0.156	0.8757	0.418～0.598
≥ S3	HBsAg-HQ	0.712^d	0.042	5.045	< 0.001	0.632～0.784	0.572ⁱ	0.052	1.391	0.1641	0.481～0.659
	HBsAg-QT	0.720^d	0.041	5.327	< 0.001	0.640～0.791	0.540ⁱ	0.053	0.645	0.5192	0.444～0.623
≥ S4	HBsAg-HQ	0.739^e	0.046	5.159	< 0.001	0.660～0.808	0.552^j	0.064	0.810	0.4177	0.461～0.640
	HBsAg-QT	0.745^e	0.045	5.476	< 0.001	0.666～0.813	0.508^j	0.065	0.058	0.9536	0.414～0.593

表4 血清HBsAg-HQ与HBsAg-QT预测HBeAg阳性患者肝组织不同病理状态的最佳截断值及其对应的诊断参数

病理状态	HBsAg^*	截断值	灵敏度（%）	特异度（%）	Youden指数	阳性预测值（%）	阴性预测值（%）	预测指数
≥ G2	HBsAg-HQ	≤ 7.216	73.61	58.67	0.323	63.1	69.8	0.329
	HBsAg-QT	≤ 7.555	88.89	46.67	0.356	61.5	81.4	0.429
≥ G3	HBsAg-HQ	≤ 7.351	87.18	43.52	0.307	35.8	90.4	0.262
	HBsAg-QT	≤ 7.555	97.44	38.89	0.363	36.5	97.7	0.342
≥ S2	HBsAg-HQ	≤ 7.622	89.01	42.86	0.319	71.7	70.6	0.423
	HBsAg-QT	≤ 7.555	84.62	51.79	0.364	74.0	67.4	0.414
≥ S3	HBsAg-HQ	≤ 7.315	86.79	53.19	0.400	51.1	87.7	0.388
	HBsAg-QT	≤ 7.555	98.11	44.68	0.428	50.0	97.7	0.477
≥ S4	HBsAg-HQ	≤ 6.865	81.25	64.35	0.456	38.8	92.5	0.313
	HBsAg-QT	≤ 6.792	75.00	67.83	0.428	39.3	90.7	0.300

表4 血清HBsAg-HQ与HBsAg-QT预测HBeAg阳性患者肝组织不同病理状态的最佳截断值及其对应的诊断参数

病理状态	HBsAg^*	截断值	灵敏度（%）	特异度（%）	Youden指数	阳性预测值（%）	阴性预测值（%）	预测指数
≥ G2	HBsAg-HQ	≤ 7.216	73.61	58.67	0.323	63.1	69.8	0.329
	HBsAg-QT	≤ 7.555	88.89	46.67	0.356	61.5	81.4	0.429
≥ G3	HBsAg-HQ	≤ 7.351	87.18	43.52	0.307	35.8	90.4	0.262
	HBsAg-QT	≤ 7.555	97.44	38.89	0.363	36.5	97.7	0.342
≥ S2	HBsAg-HQ	≤ 7.622	89.01	42.86	0.319	71.7	70.6	0.423
	HBsAg-QT	≤ 7.555	84.62	51.79	0.364	74.0	67.4	0.414
≥ S3	HBsAg-HQ	≤ 7.315	86.79	53.19	0.400	51.1	87.7	0.388
	HBsAg-QT	≤ 7.555	98.11	44.68	0.428	50.0	97.7	0.477
≥ S4	HBsAg-HQ	≤ 6.865	81.25	64.35	0.456	38.8	92.5	0.313
	HBsAg-QT	≤ 6.792	75.00	67.83	0.428	39.3	90.7	0.300

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Consistency between quantitative Lumipulse HBsAg-HQ and Architect HBsAg-QT, and their predictive efficacy on liver tissue pathological state of chronic hepatitis B

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Consistency between quantitative Lumipulse HBsAg-HQ and Architect HBsAg-QT, and their predictive efficacy on liver tissue pathological state of chronic hepatitis B