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

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

Abstract

Abstract:

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

Zhanqing Zhang, Wei Lu, Xinlan Zhou, Yanbing Wang, Rongrong Ding, Dan Huang, Xiufen Li. Consistency between quantitative Lumipulse HBsAg-HQ and Architect HBsAg-QT, and their predictive efficacy on liver tissue pathological state of chronic hepatitis B[J]. Chinese Journal of Experimental and Clinical Infectious Diseases(Electronic Edition), 2017, 11(05): 447-454.

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References 32

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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

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

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）

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）

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

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