Consistency of 2 HBsAg quantitation determination systems in different HBV infection phases and different genotypes

doi:10.3969/j.issn.1673-8640.2016.04.010

Abstract

Abstract:

Objective To analyze the consistency of Roche MODULAR E170 electrochemiluminescence immunoassay system（Roche E170）and Abbott i2000 chemiluminescence microparticle immunoassay system（Abbott i2000）for hepatitis B surface antigen（HBsAg） quantitation determination in different hepatitis B virus（HBV）infection phases and different genotypes. Methods A total of 125 serum samples were collected from chronic hepatitis B patients without antiviral treatment,and they were classified into 4 different phases according to the Guideline of Prevention and Treatment for Chronic Hepatitis B,including immune tolerant phase,immune clearance phase,low replicative phase and hepatitis B e antigen（HBeAg）-negative hepatitis phase. Simultaneously,they were classified according to genotypes（B/C）and different HBsAg levels（HBsAg≤1 000 IU/mL / HBsAg>1 000 IU/mL）as well. All the samples were determined by the 2 systems,and the consistency was analyzed. Results The correlation and consistency of the 2 systems were good（r=0.989,P<0.001）. The correlations of the 4 different HBV infection phases were good （r=0.977-0.993,P<0.001）. The consistencies of the 2 systems during immune clearance phase,low replicative phase and HBeAg-negative hepatitis phase were good. However,during immune tolerant phase,the results of Roche E170 were higher than those of Abbott i2000,and the bias was 0.114 log IU/mL. For B and C genotypes,the correlation and consistency were good（r >0.95,P<0.001）. The 2 systems' r was 0.959 in high HBsAg level group,and the bias between Roche E170 and Abbott i2000 was 0.076 log IU/mL. Even though the correlation was poor,it was falling in professional acceptable range. Conclusions The consistencies of the 2 systems for different HBV infection phases and different genotypes are good,but during immune tolerant phase and in high HBsAg level samples,the same system should be used to evaluate the efficacy of antiviral therapy,in order to avoid differences.

Key words: Hepatitis B surface antigen, Quantitation determination, Correlation, Consistency

CLC Number:

R446.62

LIU Yang, PENG Daorong, MA Yueyun, CHENG Xiaodong, ZHANG Tao, WANG Jing, HAO Xiaoke. Consistency of 2 HBsAg quantitation determination systems in different HBV infection phases and different genotypes[J]. Laboratory Medicine, 2016, 31(4): 288-292.

Figures/Tables 4

References 11

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组别	例数	年龄（岁）	性别（男/女）	HBsAg（log IU/mL）	基因分型（B/C）	HBsAg(≤/>1 000 IU/mL)
免疫耐受期组	26	24.68±9.69	9/17	4.25±0.86	6/20	0/26
免疫清除期组	31	37.57±11.18	26/5	3.51±1.20	5/26	1/30
低复制期组	45	39.89±13.07	27/18	2.99±1.01	10/33	20/25
再活动期组	23	42.95±13.10	15/8	2.97±1.25	5/18	10/13
合计	125	36.75±13.47	77/48	3.38±1.19	26/97	31/94

组别	例数	年龄（岁）	性别（男/女）	HBsAg（log IU/mL）	基因分型（B/C）	HBsAg(≤/>1 000 IU/mL)
免疫耐受期组	26	24.68±9.69	9/17	4.25±0.86	6/20	0/26
免疫清除期组	31	37.57±11.18	26/5	3.51±1.20	5/26	1/30
低复制期组	45	39.89±13.07	27/18	2.99±1.01	10/33	20/25
再活动期组	23	42.95±13.10	15/8	2.97±1.25	5/18	10/13
合计	125	36.75±13.47	77/48	3.38±1.19	26/97	31/94

组别	r值	偏差（log IU/mL）	标准差	95%一致性界限
组别	r值	偏差（log IU/mL）	标准差	-1.96s	+1.96s
B基因型组	0.980	0.005	0.144	-0.278	0.289
C基因型组	0.987	0.042	0.188	-0.327	0.413
低水平组	0.986	-0.055	0.149	-0.348	0.237
高水平组	0.959	0.076	0.179	-0.283	0.434

组别	r值	偏差（log IU/mL）	标准差	95%一致性界限
组别	r值	偏差（log IU/mL）	标准差	-1.96s	+1.96s
B基因型组	0.980	0.005	0.144	-0.278	0.289
C基因型组	0.987	0.042	0.188	-0.327	0.413
低水平组	0.986	-0.055	0.149	-0.348	0.237
高水平组	0.959	0.076	0.179	-0.283	0.434

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