Blood Center of Zhejiang Province, Jianye Road 789, Hangzhou, Zhejiang, 310052, People's Republic of China.
Key Laboratory of Blood Safety Research of Zhejiang Province, Jianye Road 789, Hangzhou, Zhejiang, 310052, People's Republic of China.
BMC Infect Dis. 2022 Mar 23;22(1):279. doi: 10.1186/s12879-022-07279-5.
Since 2010, the Blood Center of Zhejiang province, China, has conducted a pilot nucleic acid amplification testing (NAT) screening of blood donors for Hepatitis B virus (HBV), Hepatitis C virus (HCV), and Human immunodeficiency virus (HIV). This study aims to assess the results of NAT testing over 10 years to establish the effects and factors influencing NAT yields of HBV, HCV, and HIV.
Blood donations from seven different blood services were screened for HBV DNA, HCV RNA, and HIV RNA using 6 mini pools (6MP) or individual donation (ID)-NAT method between August 1, 2010, and December 31, 2019, at the NAT centralized screening center. We compared 3 transcription-mediated amplification (TMA) assays and 2 polymerase chain reaction (PCR) assays. Further, HBV, HCV, and HIV NAT yields were calculated and donor characteristics and prevalence of HBV NAT yields analyzed. Donors with HCV and HIV NAT yield were also followed up.
1916.31 per million donations were NAT screening positive overall. The NAT yields for HBV, HCV, HIV and non-discriminating reactive were 1062.90 per million, 0.97 per million, 1.45 per million, and 850.99 per million, respectively, which varied in the seven blood services and different years. HBV NAT yields were higher than those of HCV and HIV and varied across demographic groups. Risk factors included being male, old age, low education level, and first-time donors. We found no differences in NAT yields of HBV, HCV, and HIV between the 3 TMA and 2 PCR assays; nonetheless, statistically, significant differences were noted between the five assays.
In summary, NAT screening in blood donations reduces the risk of transfusion-transmitted infections and shortens the window period for serological marker screening. Therefore, a sensitive NAT screening method, ID-NAT workflow, and recruitment of regular low-risk donors are critical for blood safety.
自 2010 年以来,中国浙江省血液中心对献血者进行了乙型肝炎病毒(HBV)、丙型肝炎病毒(HCV)和人类免疫缺陷病毒(HIV)的核酸扩增检测(NAT)筛查试点。本研究旨在评估 10 年来的 NAT 检测结果,以确定 HBV、HCV 和 HIV 的 NAT 产量的影响因素和影响因素。
2010 年 8 月 1 日至 2019 年 12 月 31 日,在 NAT 集中筛查中心,使用 6 个迷你池(6MP)或个体供体(ID)-NAT 方法对来自七个不同血站的血液进行 HBV DNA、HCV RNA 和 HIV RNA 筛查。我们比较了 3 种转录介导扩增(TMA)检测法和 2 种聚合酶链反应(PCR)检测法。此外,还计算了 HBV、HCV 和 HIV 的 NAT 产量,并分析了供体特征和 HBV NAT 产量的流行情况。对 HCV 和 HIV NAT 产量阳性的供体进行了随访。
总体而言,有 1916.31/百万人份的筛查呈 NAT 阳性。HBV、HCV、HIV 和非鉴别反应的 NAT 产量分别为 1062.90/百万人份、0.97/百万人份、1.45/百万人份和 850.99/百万人份,7 个血站和不同年份的 NAT 产量有所不同。HBV NAT 产量高于 HCV 和 HIV,且在不同人群中有所不同。危险因素包括男性、年龄较大、教育程度较低和初次供体。我们发现 3 种 TMA 和 2 种 PCR 检测法的 HBV、HCV 和 HIV 的 NAT 产量无差异,但 5 种检测法之间存在统计学差异。
总之,血液捐献的 NAT 筛查降低了输血传播感染的风险,并缩短了血清标志物筛查的窗口期。因此,采用敏感的 NAT 筛查方法、ID-NAT 工作流程和招募定期低风险供体对于血液安全至关重要。