Detection of HIV-1 and HCV infections among antibody-negative blood donors by nucleic acid-amplification testing
Detection of HIV-1 and HCV infections among antibody-negative blood donors by nucleic acid-amplification testing
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DOI：
10.1056/nejmoa040085
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发表时间：
2004-08-19
影响因子：
158.5
通讯作者：
Busch, MP
中科院分区：
文献类型：
--
作者：
Stramer, SL;Glynn, SA;Busch, MP
背景通过核酸扩增对献血者进行人体免疫缺陷病毒 1 型 (HIV-1) 和丙型肝炎病毒 (HCV) RNA 检测作为一项研究性筛选试验在 1999 年中期在美国引入，以识别血清转化前窗口期的献血者。在核酸筛查的前三年中，美国主要采血项目对 16 至 24 份献血进行了检测。 结果 在筛查的 37,164,054 份单位中，有 12 份被确认为 HIV-1 RNA 阳性，即 310 万份献血中只有 1 份被确认为 HIV-1 p24 抗原检测中检测到的其中 2 份。对于 HCV，在筛查的 39,721,404 个单位中，有 170 个被确认为 HCV RNA 阳性，即 230,000 份捐赠中有 1 份（或者根据使用更灵敏的 HCV 抗体测试确认为 HCV RNA 阳性的 139 份捐赠的基础上，270,000 份捐赠中有 1 份）。首次献血者的HCV和HIV-1核酸扩增检测阳性率分别是重复献血者的3.3倍和4.1倍。对 67 名 HCV RNA 阳性捐献者的后续研究表明，血清转化发生在索引捐献后中位 35 天，随后病毒血症的解决率较低；记录了三例长期免疫沉默的 HCV 感染病例。 结论 Minipool 核酸扩增检测每年有助于预防约 5 例 HIV-1 感染和 56 例 HCV 感染的传播，并将通过输血传播 HIV-1 和 HCV 的残余风险降低至约 200 万血液单位中的 1 例。
BACKGROUNDTesting of blood donors for human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) RNA by means of nucleic acid amplification was introduced in the United States as an investigational screening test in mid-1999 to identify donations made during the window period before seroconversion.METHODSWe analyzed all antibody-nonreactive donations that were confirmed to be positive for HIV-1 and HCV RNA on nucleic acid - amplification testing of "minipools" ( pools of 16 to 24 donations) by the main blood-collection programs in the United States during the first three years of nucleic acid screening.RESULTSAmong 37,164,054 units screened, 12 were confirmed to be positive for HIV-1 RNA or 1 in 3.1 million donations - only 2 of which were detected by HIV-1 p24 antigen testing. For HCV, of 39,721,404 units screened, 170 were confirmed to be positive for HCV RNA, or 1 in 230,000 donations ( or 1 in 270,000 on the basis of 139 donations confirmed to be positive for HCV RNA with the use of a more sensitive HCV-antibody test). The respective rates of positive HCV and HIV-1 nucleic acid - amplification tests were 3.3 and 4.1 times as high among first-time donors as among donors who gave blood repeatedly. Follow-up studies of 67 HCV RNA - positive donors demonstrated that seroconversion occurred a median of 35 days after the index donation, followed by a low rate of resolution of viremia; three cases of long-term immunologically silent HCV infection were documented.CONCLUSIONS Minipool nucleic acid - amplification testing has helped prevent the transmission of approximately 5 HIV-1 infections and 56 HCV infections annually and has reduced the residual risk of transfusion-transmitted HIV-1 and HCV to approximately 1 in 2 million blood units.