High throughput screening of 16 million serologically negative blood donors for hepatitis B virus, hepatitis C virus and human immunodeficiency virus type-1 by nucleic acid amplification testing with specific and sensitive multiplex reagent in Japan
High throughput screening of 16 million serologically negative blood donors for hepatitis B virus, hepatitis C virus and human immunodeficiency virus type-1 by nucleic acid amplification testing with specific and sensitive multiplex reagent in Japan
复制标题
DOI：
10.1016/s0166-0934(03)00215-5
复制
发表时间：
2003-09-01
影响因子：
3.1
通讯作者：
Nishioka, K
中科院分区：
文献类型：
--
作者：
Mine, H;Emura, H;Nishioka, K
1999年7月1日，日本红十字会输血服务中心对经过血清学筛查后自愿捐献的血液进行了全国范围的B型肝炎病毒（HBV）、丙型肝炎病毒（HCV）和人类免疫缺陷病毒1型（HIV-1）核酸扩增检测（NAT），用于输血和血浆分离。从2000年2月1日起，开始对50份血清学筛查阴性的捐献血液进行HBV、HCV和HIV-1 NAT筛查，并在献血后1天内报告结果。建立了快速运输、电子通信、自动化标本制备、合并以及自动化扩增和检测系统。目前，NAT筛查在献血后1天内进行。本报告描述了通过NAT的血液筛查系统以及使用多重试剂同时筛查HBV、HCV和HIV-1从超过1600万份血液样本中获得的结果。2000年2月1日至2002年12月31日，共检测血清学阴性标本16012175份，检出B型肝炎病毒DNA（HBV DNA）308份。输入体积为0.2ml的50池NAT筛查的灵敏度显著高于高灵敏度HBsAg检测。46例HCV RNA阳性，6例HIV-1 RNA阳性。这些病例经HCV抗体和HIV-1抗体筛查均未检出。假阳性率为0.18%。NAT系统是从血清学筛查测试阴性的无偿自愿捐赠中开发出来的。我们为医疗机构提供经NAT筛查HBV、HCV和HIV-1的血液制品，用于输血，并为分离提供原料血浆。这是第一个通过NAT筛查预防输血传播的HBV、HCV和HIV-1感染的自动化综合系统。(C)2003年由Elsevier B. V.出版
Nationwide nucleic acid amplification testing (NAT) for hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus type 1 (HIV-1) of blood donated voluntarily after serological screening was implemented on July 1st 1999 for transfusion and plasma fractionation by the Japanese Red Cross blood transfusion services. From February 1st 2000, HBV, HCV and HIV-1 NAT screening of pools of 50 negative serologically screened donated blood was started and the results were reported within 1 day after blood donation. Systems were established for rapid shipment, electronic communication, automated specimen preparation, pooling and automated amplification and detection. At present, NAT screening is carried out within 1 day after donation. This report describes the blood screening system by NAT and the results obtained from over 16 million blood samples using simultaneous screening for HBV, HCV and HIV-1 with multiplex reagent. Between February 1, 2000 and December 31, 2002, 16012175 serologically negative units were tested by NAT. 308 units with Hepatitis B virus DNA (HBV DNA) were detected. The sensitivity of 50 pool NAT screening with input volume of 0.2 ml is significantly higher than that of highly sensitive HBsAg testing. 46 cases with HCV RNA and six cases with HIV-1 RNA were detected. These cases were not detected by HCV antibody and HIV-1 antibody screening. The false positive rate was 0.18%. The NAT system was developed from serological screening test negative non-remunerated voluntary donations. We supply blood products to medical organizations after screening by NAT for HBV, HCV and HIV-1 for transfusion and source plasma for fractionation. This is the first automated integrated system for prevention of transfusion transmitted HBV, HCV and HIV-1 infections, by NAT screening. (C) 2003 Published by Elsevier B.V.