前S1抗原检测在献血人群的HBV感染筛查中的应用

Application of Detection of Pre-S1 Antigen in Screening Blood Donators with HBV Infection

目的:通过比较献血人群中谷丙转氨酶、乙肝表面抗原和前S1抗原检测与HBV-DNA检测结果的一致性,探讨前S1抗原检测在献血人群中筛查乙肝病毒感染者的应用价值。方法:1080份献血样本中,采用ELISA法检测前S1抗原,PCR法检测HBV-DNA,分析前S1抗原检测与HBV-DNA检测的一致性。结果:(1)1000例合格的献血人群中,前S1抗原的阳性率为0.3%,HBV-DNA阳性率为0.1%,两者呈中度一致性(Kappa值=0.499),且有统计学意义(P<0.05)。(2)1080例样本中,ALT、HBs Ag、前S1抗原的阳性率分别为5.83%、1.76%、1.67%,HBV-DNA阳性率为0.93%,ALT检测法与HBV-DNA检测无一致性(Kappa值=-0.0162);HBs Ag检测与HBV-DNA检测呈高度一致性(Kappa值=0.6160),前S1抗原检测与HBV-DNA检测呈高度一致性(Kappa值=0.7108),二者均有统计学意义(P<0.05)。(3)ALT和HBs Ag两项联合检测及ALT、HBs Ag和前S1抗原三项联合检测的阳性率分别为7.41%、7.69%,HBV-DNA阳性率为0.93%。两项联合检测法与HBV-DNA检验结果一致(Kappa值=0.1866),三项联合检测法与HBV-DNA检验结果一致(Kappa值=0.2019),均有统计学意义(P<0.05)。结论:前S1抗原检测与HBV-DNA检测有较高一致性,能够减少献血人群中HBV感染的漏检;将ALT、HBs Ag和前S1抗原进行联合检测能够提高HBV感染筛查率。

Objective： To investigate the value of determining Pre-S 1 antigen in screening blood donators with HBV infection by comparing the consistency between ALT, HBsAg, Pre-S1 antigen tests and HBV-DNA tests for blood donators. Methods： A total of 1080 samples were respectively tested by Pre-S1 antigen with an ELISA method and HBV-DNA with a PCR method. Based on the results of tests, the consistency between Pre-S1 antigen and HBV-DNA tests was analyzed. Results： （1）In 1000 cases of qualified samples, the positive rate of Pre-S 1 antigen was 0.3%, and the positive rate of HBV-DNA was 0.1%, these two test indexes had a medium-degree consistency （Kappa value 0.499）（P〈0.05）. （2）In 1080 cases of blood samples, the positive rates ofALT, HBsAg and Pre-S1 antigen were 5.83%, 1.76% and 1.67%, and the positive rate of HBV-DNA was 0.93%. There was no statistical difference in the positive rate of HBsAg and Pre-S1 antigen but ALT respectively compared that of HBV-DNA （P〉0.05）. There were statistical difference for the positive rate of ALT, HBsAg and Pre-S1 antigen respectively compared that of HBV-DNA （P〈 0.05）. Kappa＇s test showed no consistency between ALT and HBV-DNA （Kappa value -0.0162）, high-degree consistency between HBsAg and HBV-DNA （Kappa value 0.6160） and high-degree consistency between Pre-S1 antigen and HBV-DNA （Kappa value 0.7108） were found （P〈0.05）. （3）In 1080 cases of blood samples, the positive rate of combined ALT and HBsAg was 7.41%, the positive rate of combined ALT plus HBsAg plus Pre-S1 antigen was 7.69%, and the positive rate of HBV-DNA was 0.93%. There were statistical difference in the positive rates of the combined with Pre-S1 antigen and without Pre-S1 antigen respectively compared that of HBV-DNA （P〈0.05）. Kappa＇s test showed consistency between combined ALT plus HBsAg and HBV-DNA with a Kappa value of 0.1866, as well as a consistency between combined ALT plus HBsAg plus Pre-S1 antigen and HBV-DNA with a Kappa value of 0.2019 （P〈0.05）. Conclusions： The test of Pre-S1 antigen had a superior consistency with test of HBV-DNA, and could be used to screen the untested donated blood samples with HBV. Furthermore, a combined test of Pre-S1 antigen, ALT and HBsAg could increase the screening rates of donated blood samples with HBV.