目的分析血液筛查中无偿献血者HIV阳性反应的多样性表现,研究献血者HIV检测阳性反应的血清学和分子生物学状态,为今后献血者招募和检测工作提供指导和借鉴。方法对2010年11月-2014年6月北京市无偿献血者的血液标本进行2次HIV血清学ELISA检测和1次HIV RNA核酸单人份联检和鉴别检测。将ELISA和/或NAT反应性标本送至北京市疾病预防控制中心进行Western Blot（WB）确证试验。对部分HIV ELISA窗口期标本进行HIV荧光定量PCR（RT-PCR）检测,病毒含量低于检测下限的标本,使用probit方法推断其病毒载量。结果1）血清学及核酸检测均阳性反应标本453例中,4例标本只有4代试剂检测为反应性,且2例在RT-PCR中可以检测到HIV-RNA。2）HIV ELISA窗口期献血者21例,均为19-39岁男性。12例进行荧光定量PCR检测的HIV ELISA窗口期标本,病毒浓度分布为（6-305 000）cp/m L,且HIV病毒载量呈现线性均态分布,证明为随机献血者。有4例标本病毒浓度低于100 cp/m L,其中6 cp/m L为目前国内报道的最低HIV ELISA窗口期标本病毒浓度。3）发现HIV精英控制者（HIV elite controller）1名。结论无偿献血者中存在处于抗-HIV检测窗口期的感染者,也存在极低和极高病毒载量的HIV ELISA窗口期感染者和HIV精英控制者,因此在HIV筛查中会面临复杂化多样化的标本。
Objective To statistically analyze diverse HIV positive samples during the blood screening process,to study the serological and molecular biological features of these samples,and to provide evidence for blood donor recruitment and screening. Methods The donor samples collected from the 2010 to 2014 in Beijing were screened by routine two times enzyme-linked immunosorbent assay（ ELISA） and one time nucleic acid test（ NAT）. ELISA and / or NAT reactively samples were confirmed by Western Blot assay in the Beijing Center for Disease Prevention and Control. Qualitative nucleic acid test was performed on some samples that were non-reactive by ELISA but reactive by NAT. When the HIV viral load was not detectable by qualitative nucleic acid test,the probit analysis was used to estimate the HIV viral load. Results 1）. 453 samples were both reactive in ELISA and NAT test. Among them,4 samples were non-reactive by third-generation HIV ELSIA screen reagent,but were reactive by fourth-generation reagent. In two out of the four samples,HIV-RNA were detected by RT-PCR. 2）. 21 samples were screened by NAT during window phase. These donors were all 19- 38 years old males. 12 HIV ELISA window period samples were performed with qualitative nucleic acid test（ ranged,6- 305,000 cps / m L）,and 4samples＇ HIV virus concentration were below 100 cps / m L. 6 cps / m L HIV ELISA window period sample was the lowest virus load found in China. The HIV viral load showed a linear mean distribution,which proved that they were not test-seekers.3）. We have screened one HIV elite controller. Conclusion Diverse HIV positive individuals in this study consist of HIV antibody detection window period infectors,the extreme low virus load HIV window period carrier and HIV elite controller.During HIV screening process,complex and diverse samples would be expected.
Chinese Journal of Blood Transfusion