[Study on Reentry Evaluation Mode for Blood Donors Used to be HBV Reactive in Jiangsu Province].

To evaluate the risk of reentry in HBV reactive blood donors and feasibility of HBV reentry strategy.HBsAg+ or HBV DNA+ donors who had been quarantined for more than 6 months in Jiangsu Province could propose for reentry application. Blood samples were routinely screened by dual-ELISA for HBsAg, anti-HCV, HIV Ab/Ag, and anti- Treponema pallidum and those non-reactive ones were tested by minipool nucleic acid testing (NAT) for three times. To identify occult HBV donors, samples of NAT non-reactive were further tested by electrochemiluminescence immunoassay (ECLIA) for HBV seromarkers (including HBsAg, HBsAb, HBeAg, HBeAb, and HBcAb). Donors of only 4 ECLIA patterns were accepted to reentry, including all 5 HBV seromarkers negative, anti-HBs only but having history of hepatitis B vaccine injection, HBcAb only, HBsAb+ / HBcAb+ with HBsAb more than 200 IU/L. Additionally, the detection rate of HBV infection was compared between routine screening mode and ECLIA, as well as the reentry qualified rate of HBsAg+ and HBV DNA+ blood donors.From Oct. 2016 to Aug. 2019, a total of 737 HBV reactive donors had applied for reentry, including 667 HBsAg+ reactive and 70 HBV DNA+ reactive donors. Among 3 screening methods, the highest HBV detection rate (43.15%, 318/737) was observed on ECLIA, while only 4.75% (35/737) on ELISA and 3.12% (23/737) on NAT, respectively. Among 4 qualified patterns of HBV serological markers, the highest proportion was found in the all negative group (22.90%, 155/677), followed by the group with HBsAb+ only and history of hepatitis B vaccine injection (19.35%, 131/677), and the median concentration of HBsAb was 237.7 IU/L. The unqualified rate of HBV DNA+ donors was 82.86%, which was significantly higher than 47.98% of HBsAg+ donors.Routine screening tests merely based on ELISA and NAT could miss occult HBV donors and may not be sufficient for blood safety. HBsAb concentration and vaccine injection history should be included in the evaluation of HBV reactive donors who intend to apply for reentry. There is a relatively larger residual risk of occult HBV infection in blood donors quarantined for HBV DNA reactive.江苏省HBV反应性献血者归队评估模式及其可行性探讨.评估HBV反应性献血者归队风险，探讨HBV归队策略的可行性.对江苏地区既往因HBsAg+或HBV DNA+被屏蔽的无偿献血人群，屏蔽期6个月后重新抽血，进行常规ELISA（HBsAg、抗HCV、HIV Ab/Ag、抗TP ELISA）筛查和3次NAT混样检测。对于ELISA和核酸无反应性的标本，再采用电化学发光法（ECLIA）进行HBV血清学标志物（HBsAg、HBsAb、HBeAg、HBeAb、HBcAb）检测。结合HBV血清学标志物检测结果与献血者乙肝疫苗注射史，设定4种HBV血清学标志物合格模式，综合评估献血者是否符合归队要求。另外，比较常规筛查与ECLIA法两种检测模式在HBV感染的检出率及HBsAg+和HBV DNA+献血者的归队合格率上的差异.2016年10月至2019年8月共有737名HBV初筛反应性献血者提出归队申请，其中既往因HBsAg+或HBV DNA+被屏蔽的献血者分别为667例和70例。737名献血者重新抽血并接受检测，其中通过血清学标志物检测对HBV的检出率最高，占比43.15%（318/737），HBsAg ELISA法和NAT检测的HBV检出率分别为4.75%（35/737）和3.12%（23/ 737）。HBV血清学标志物合格模式中，占比最高的是5项全阴组（22.90%，155/677），其次为仅HBsAb+且有乙肝疫苗注射史组（19.35%，131/677），HBsAb浓度中位数为237.7 IU/L。既往HBV DNA+献血者归队检测不合格率（82.86%）显著高于既往HBsAg+献血者（47.98%）.ELISA和NAT的筛查模式不足以保证血液的安全性，应将ECLIA法、血清学标志物检测及疫苗注射史纳入HBV反应性献血者归队的评估指标。既往HBV DNA反应性被屏蔽献血者归队存在较大隐匿性HBV感染残余风险.