Lee S R, Peterson J, Niven P, Bahl C, Page E, DeLeys R, Giordano-Schmidt D, Baggett D, Green G
Ortho Clinical Diagnostics, Raritan, NJ, USA.
Vox Sang. 2001 Jan;80(1):19-23. doi: 10.1046/j.1423-0410.2001.00008.x.
Recent studies have suggested that potentially infectious donations provided during the antibody-negative 'window' phase of hepatitis C virus (HCV) infection may be identified by testing for viral RNA or HCV core protein. We therefore evaluated the performance of an HCV antigen enzyme-linked immunosorbent assay (ELISA) for identification of window-phase donations and for prospective screening of blood donors.
One-hundred and twenty-eight archived plasma donations containing HCV RNA, but lacking antibody to HCV (anti-HCV), were tested by using the HCV antigen ELISA, together with 9951 freshly collected serum and plasma specimens from blood donors.
HCV core antigen was detected in 94% (120/128) of window-phase plasma donations. Overall specificity in freshly collected blood donor specimens was 99.74%. Two putative window-phase donations containing HCV core protein and viral RNA were identified from paid plasma donors by prospective testing with the HCV antigen ELISA.
These results indicate that an HCV antigen ELISA can identify almost all (94%) of viraemic donations given during the seronegative window phase of infection. The performance of the HCV antigen ELISA appears to be suitable for large-scale screening of blood donations.
近期研究表明，在丙型肝炎病毒（HCV）感染的抗体阴性“窗口期”所提供的可能具有传染性的献血，可通过检测病毒RNA或HCV核心蛋白来识别。因此，我们评估了一种HCV抗原酶联免疫吸附测定（ELISA）在识别窗口期献血以及对献血者进行前瞻性筛查方面的性能。
使用HCV抗原ELISA对128份含有HCV RNA但缺乏抗HCV抗体（抗-HCV）的存档血浆献血样本进行检测，并对9951份来自献血者的新鲜采集的血清和血浆样本进行检测。
在94%（(120/128)）的窗口期血浆献血样本中检测到HCV核心抗原。在新鲜采集的献血者样本中总体特异性为99.74%。通过使用HCV抗原ELISA进行前瞻性检测，从有偿血浆献血者中识别出两份含有HCV核心蛋白和病毒RNA的假定窗口期献血样本。
这些结果表明，HCV抗原ELISA能够识别几乎所有（94%）在感染血清阴性窗口期所进行的病毒血症献血。HCV抗原ELISA的性能似乎适用于大规模的献血筛查。
