血液筛查中核酸检测技术降低HBV感染风险的研究

Effectiveness of nucleic acid test to reduce the risk of hepatitis B virus infection during blood screening

目的通过对HBsAg阴性和HBV DNA阳性献血者的血液标本探讨抗-HBs和抗-HBc分布情况,分析潜在HBV感染的风险。方法收集2017年1月—2019年12月邯郸地区无偿献血者263631份血液样品,采用酶联免疫吸附测定(enzyme linked immunosorbent assay,ELISA)方法检测,ELISA检测无反应性或单试剂反应性的标本进行8混1核酸检测,将最终判定HBV DNA阳性的标本,再次进行罗氏核酸检测和化学发光检测,并对所得结果进行对比分析。结果68例HBV DNA阳性中,1992年前后出生HBV(含HBsAg和HBV DNA)阳性献血者人数构成比差异有统计学意义(χ^(2)=37.113,P<0.05);抗-HBs阳性组共16例,构成比为23.53%,低于抗-HBs阴性组,差异有统计学意义(χ^(2)=27.812,P<0.05);抗-HBs阳性合并抗-HBc阳性例数最多(11例),不同血清学模式构成比不同。结论核酸检测技术可检出为无抗-HBs或低抗-HBs水平的血液,最大程度降低了因输血传播HBV的残余风险。

Objective To investigate the distribution of hepatitis B surface antibody(anti-HBs)and hepatitis B core antibody(anti-HBc)in blood samples from blood donors negative for hepatitis B surface antigen(HBsAg)and positive for hepatitis B virus(HBV)DNA,and to evaluate the potential risk of HBV infection.Methods A total of 263631 blood samples were collected from voluntary blood donors in Handan City from January 2017 to December 2019 for enzyme-linked immunosorbent assay(ELISA).Blood samples without response to ELISA or with responses to a single reagent kit were subjected to nucleic acid test with samples pooled at a ratio of 1∶8.The blood samples tested positive for HBV DNA were used for Roche nucleic acid test and chemiluminescence assay.The detection results were analyzed.Results Among the 68 blood donors positive for HBV DNA,there was a significant difference in the constituent ratio of HBV-positive(positive for HBsAg or HBV DNA)cases born before and after 1992(χ^(2)=37.113,P<0.05).The proportion of 16 cases HBV DNA-positive patients was significantly lower in the anti-HBs positive group(23.53%)than that in anti-HBs negative group,the difference was statistically significant(χ^(2)=27.812,P<0.05).The largest number was seen in individuals positive for both anti-HBs and anti-HBc(11 cases),and there was a significant difference in the constituent ratio of different serological patterns.Conclusions Nucleic acid test is effective to detect blood samples without anti-HBs or with low-titer HBs,which minimizes the residual risk of transfusion-transmitted HBV infections.