Lee S R, Wood C L, Lane M J, Francis B, Gust C, Higgs C M, Nelles M J, Polito A, DiNello R, Achord D
Ortho Diagnostic Systems, Raritan, New Jersey, USA.
Transfusion. 1995 Oct;35(10):845-9. doi: 10.1046/j.1537-2995.1995.351096026366.x.
Routine screening of blood donations with second-generation hepatitis hepatitis C virus (HCV) assays has substantially reduced the occurrence of posttransfusion hepatitis. However, following the development of third-generation assays, several studies indicated that these assays may identify HCV-infected individuals who are not identified by second-generation assays.
The sensitivity of a third-generation HCV enzyme-linked immunosorbent assay (ELISA-3) was compared with a second-generation ELISA (ELISA-2) in a side-by-side study of 9936 commercial blood donors. ELISA-reactive specimens were subjected to supplemental analysis by third-generation recombinant immunoblot assay and polymerase chain reaction.
ELISA-3 demonstrated greater sensitivity than ELISA-2, detecting 1 additional recombinant immunoblot assay-positive specimen per 2000 tested. ELISA-3 also detected 1 additional HCV-infectious polymerase chain reaction-positive unit among approximately 10,000 units screened.
The incremental sensitivity achieved with ELISA-3 can be expected to eliminate approximately 20 infectious donations per week among those made by commercial donors in the United States. In accordance with previous studies, most of the improved sensitivity of ELISA-3 derives from its increased detection of anti-c33c (NS3), rather than from the inclusion of HCV antigen NS5.
采用第二代丙型肝炎病毒（HCV）检测方法对献血进行常规筛查，已大幅降低了输血后肝炎的发生率。然而，随着第三代检测方法的发展，多项研究表明，这些检测方法可能会识别出第二代检测方法无法识别的HCV感染个体。
在一项对9936名商业献血者的并行研究中，将第三代HCV酶联免疫吸附测定（ELISA-3）的灵敏度与第二代ELISA（ELISA-2）进行了比较。对ELISA反应性标本进行了第三代重组免疫印迹测定和聚合酶链反应的补充分析。
ELISA-3的灵敏度高于ELISA-2，每检测2000份标本可多检测出1份重组免疫印迹测定阳性标本。在筛查的约10000个单位中，ELISA-3还多检测出1个HCV感染性聚合酶链反应阳性单位。
预计ELISA-3所实现的灵敏度提高，可在美国商业献血者每周的献血中消除约20份感染性献血。与先前的研究一致，ELISA-3灵敏度的提高主要源于其对抗-c33c（NS3）检测能力的增强，而非源于包含HCV抗原NS5。
