国产ELISA法乙肝表面抗原检测试剂在乙肝流行病学调查中的应用评价

Evaluation of application of domestic ELISA method with HBV HBsAg detection reagents in hepatitis-B epidemiology investigation

目的评价国产酶联免疫吸附试验(ELISA)法乙肝表面抗原(HBsAg)检测试剂在人群乙肝流行病学调查中的应用价值。方法比较国内市场占有率较高的4种ELISA法HBsAg检测试剂,选出灵敏度和特异度高的1种,将其应用于乙肝流行病学调查中,并与雅培公司化学发光微粒子免疫分析(CMIA)法检测结果相比较。结果筛检出D公司的ELISA法HBsAg检测试剂的灵敏度较高;在乙肝流行病学调查血清样本HBsAg检测中,D公司的ELISA法与雅培CMIA法检测结果相比存在差异,校正配对χ2=26.04,P<0.001,前者的灵敏度略低,为88.38%;但两者kappa值为0.937 3,表明两者有较强的一致性。阴性(滴度<0.05IU/ml)、高滴度HBsAg(≥0.5IU/ml)阳性样本,国产ELISA法检测符合率分别为100.00%、99.06%;低滴度(0.05～0.5IU/ml)样本符合率3.70%,但低滴度样本仅占1.39%。结论国产ELSIA法HBsAg检测试剂的灵敏度有待提高,有一定的漏诊率,但仍可满足一般人群乙肝慢性感染者的流行病学调查需要。

Objective To evaluate the application of domestic enzyme-linked immunosorbent assay （ELISA） with HBV HB- sAg detection reagents in the surveillance of chronic hepatitis B infection. Methods Four domestic ELISA reagents ranked higher market shares for HBsAg detection were compared for sensitivity and specificity. One was chosen for higher sensitivity and specificity,1 936 serum samples randomly selected from epidemiological field study were tested using the reagents and the results were compared with the data obtained from parallel tests using Abbott Chemiluminesent Microparticle ImmunoAssay （CMIA） reagents. Results Compared to the other three companies＂ reagents, reagent from company D was proved to have higher sensitivity in detecting HBsAg. When applied in field epidemiological study, there was significant difference between D company＇s reagent and Abbott CMIA reagent （X^2 = 21. 16, P〈0. 001）. The sensitivity of D company＇s ELISA reagent was lower （88.38%）,but the testing results between D company＇s ELISA reagent and Abbott CMIA reagent in detecting HBsAg were consistent （kappa value=0. 9373）. For negative samples （titre〈0.05 IU/ml） or samples with high HBsAg titre （titre≥ 0.5 IU/ml）, the coincidence rates of domestic ELISA reagent were 100% and 99.1% respectively. When used to detect sam- ples with low HBsAg titre （0. 05N0. 5 IU/ml）, the coincidence rate of domestic ELISA reagent was only 3.7%. However, samples with low HBsAg titre accounted for only 1.39% of all samples. Conclusion The sensitivity of domestic ELISA in de- tecting HBsAg was lower, there was a certain omission ratio, but it could still satisfy the need for epidemiological investigation of chronic HBV infection in general population.