大连市血液中心HBsAg阴性献血者HBV感染的确认与HBV核酸检出效率的评估

Confirmation of Hepatitis B virus infection in HBsAg-negative donors and efficacy of nucleic acid test for screening Hepatitis B virus in Dalian Blood Center

目的通过对HBsAg阴性献血者的HBV感染及感染类别的确认来评估HBV核酸检出的效率。方法对2010年12月2日～2013年4月30日献血者血液标本同时进行血清学（HBsAg、抗-HCV、HIV抗原／抗体、梅毒特异性抗体、谷丙转氨酶和血型）和HBV／HCV／HIV3联核酸筛查，单纯核酸反应性标本需鉴别。依据跟踪或回溯检测的血清学变化确定HBV感染者及其感染类别。结果共筛查117427名献血者合计152739份血液标本，核酸联检初次反应性标本193份。确定HBsAg（-）的HBV感染献血者94名，其中窗口期5名，一过性感染15名，OBI51名。核酸检测假阳性率占初次反应性标本的50．3％。HBsAg（-）献血人群中窗口期、一过性感染和OBI的流行率分别为6．0／10万、18．9／10万和55．3／10万。结论核酸检测对于提高献血者HBV感染的检出有着重要的作用；OBI在HBV总检出中占比远高于一过性HBV感染及窗口期感染；HBV核酸检测存在相当比例的假阳性；多次重复检测有利于假阳性的排除；为保证血液安全，核酸检测初次反应性的血液应报废，而假阳性的献血者需再评估。

Objective To evaluate the efficacy of nucleic acid test in screening Hepatitis B virus a confirmation for HBV infection stage in HBsAg screening negative blood donors. Methods From 2nd December 2010 to 30th April 2013, all sam-ples in Dalian Blood Center were screened with serological markers and triplex-NAT of HBV/HCV/HIV. Triplex-NAT yields should be discriminated. HBV infected donors and infection stages were confirmed according to sero-convertive of follow-up and/or archive samples. Results A total of 152 739 samples from 117 427 blood donors were screened. 193 HBsAg - negative samples were triplex-NAT initial reactive （IR） in which 94 were confirmed HBV infection including 5 window period in- fections （WP） , 15 transient infections and 51 occult HBV infee-tions （OBI）. False-positive rate of NAT was 50. 3% of IR. The prevalence of WP,transient infections and OBI were 6.0 × 10^ -5, 18. 9 × 10^-5 and 55.3 × 10^-5 , respectively. Coneluslon NAT plays an important role in enhancing capacity of HBV detee-tions. Most of NAT-yields are OBIs ,followed with transient infections and WP infections. One of the greatest challenges faced for NAT implementation is a high false-positive rate. Multi-repeat detection is helpful for excluding false-positive. Initial reac-tive units must be discarded and false-positive donors should be reevaluated to ensure the blood safety.