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目的:探讨乙肝表面抗原(HBsAg)酶联免疫吸附试验(ELISA)检测呈灰区、弱阳性样本采用荧光定量PCR(FQ-PCR)的复检情况。方法:选取2012-01-2014-12无偿献血者血液标本为研究对象,将献血者分为3组,A组:ELISA检测HBsAg阴性(S/CO<0.3)标本200例;B组:ELISA检测HBsAg灰区(0.7≤S/CO<1)标本792例;C组:ELISA检测HBsAg弱反应性(1≤S/CO<3)标本417例。结果:B组FQ-PCR复检21例(2.65%)HBV-DNA浓度>100IU/ml;C组FQ-PCR复检20例(4.80%)HBV-RNA浓度<100IU/ml;ELISA双试剂灰区HBV-DNA FQ-PCR阳性率高于单试剂灰区,差异有统计学意义(P<0.05);ELISA双试剂弱反应性HBV-DNA FQ-PCR阳性率与单试剂弱反应性比较差异无统计学意义(P>0.05)。结论:ELISA检测HBsAg为灰区、弱反应性标本存在一定的HBV-DNA阳性标本漏检和误诊,这部分血样采用FQ-PCR检测可提高输血安全,避免血源浪费。
OBJECTIVE: To investigate the re-examination of hepatitis B surface antigen (HBsAg) enzyme-linked immunosorbent assay (ELISA) in gray zone and weakly positive samples by fluorescence quantitative PCR (FQ-PCR). Methods: The blood samples of unpaid blood donors from January 2012 to December 2014 were selected as study objects. Blood donors were divided into three groups. Group A: 200 cases of HBsAg negative (S / CO <0.3) were detected by ELISA; Group B: 792 cases of HBsAg gray zone (0.7≤S / CO <1), and 417 cases of HBsAg poor response (1≤S / CO <3). Results: HBV-DNA concentration was 100 IU / ml in 21 cases (2.65%) in group B, 20 cases (4.80% The positive rate of HBV-DNA FQ-PCR was higher than that of single reagent (P <0.05). The positive rate of HBV-DNA FQ-PCR between weak-reactive ELISA and double-reagent was not significantly different from that of single reagent Statistical significance (P> 0.05). Conclusion: HBsAg was detected by ELISA in the gray zone. There was some undetected and misdiagnosed HBV-DNA positive specimens in the weakly reactive specimens. FQ-PCR could improve the safety of blood transfusion and avoid the blood waste.