Sensitivity of two hepatitis B virus, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) nucleic acid test systems relative to hepatitis B surface antigen, anti-HCV, anti-HIV, and p24/anti-HIV combination assays in seroconversion panels
Sensitivity of two hepatitis B virus, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) nucleic acid test systems relative to hepatitis B surface antigen, anti-HCV, anti-HIV, and p24/anti-HIV combination assays in seroconversion panels
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DOI：
10.1111/j.1537-2995.2008.01966.x
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发表时间：
2009-02-01
期刊：
影响因子：
2.9
通讯作者：
De Micco, Philippe
中科院分区：
文献类型：
--
作者：
Assal, Azzedine;Barlet, Valerie;De Micco, Philippe
与血清学检测相比，准确确定个体献血（ID）或微池（MP）NAT的感染窗口期（IWP）对于剩余风险估计至关重要。Procleix Tigris系统的相对灵敏度（Gen-Probe/Chiron）用于ID-NAT格式和cobas s 201（Roche Molecular Systems）应用于1：通过对每个标志物的5个血清转化组进行四倍重复检测，评估模拟6个微量池（MP 6）核酸检测（NAT）的6份稀释样本。根据bDNA 3.0检测建立的在上升阶段中病毒血症对数线性增加的数学分析，能够估计人类免疫缺陷病毒（HIV）和B肝炎病毒（HBV）检测的IWP。平均IWP为Tigris HIV RNA 5.5天，s 201（1：6）HIV RNA 7.4天，GenScreen Plus p24/抗HIV 17.8天，PRISM抗HIV 19.0天，Tigris HBV DNA 20.6天，s 201（1：6）HIV RNA 7.4天。6）HBV DNA 22.6天，Bio-Rad肝炎B表面抗原（HBsAg）37.8天，PRISM HBsAg 35.5天。在估计的50% NAT血清转换率下，s 201（1：6）和Tigris显示丙型肝炎病毒抗体（抗HCV）检测的平均窗口期减少时间（WPRT）为30.5至35.5天，抗HIV或p24/抗HIV联合检测为10.4至13.5天，HBsAg检测为12.8至17.2天。Tigris ID-NAT比s 201 MP 6-NAT早2天检测到HIV RNA，但在HBV血清转换组中，两种NAT系统之间的灵敏度差异不显著。没有足够的血清转化样本可用于早期HCV感染中WPRT的可靠建模，但通过转换分析灵敏度数据可以预测1.4至2.0天。与（组合的）抗原和抗体测定相比，两种多重NAT系统均显示出显著的WPRT。
Accurate determination of the infectious window period (IWP) that remains with individual-donation (ID) or minipool (MP) NAT compared to those with serology assays is essential for residual risk estimations.The relative sensitivity of the Procleix Tigris system (Gen-Probe/Chiron) used in ID-NAT format and cobas s 201 (Roche Molecular Systems) applied in 1:6 diluted samples to mimic six-minipool (MP6) nucleic acid test (NAT) was assessed by quadruplicate testing of five seroconversion panels per marker. A mathematical analysis based on the log-linear increase of viremia in the ramp-up phase, as established with bDNA 3.0 assays enabled estimation of the IWP for human immunodeficiency virus (HIV) and hepatitis B virus (HBV) assays.The mean IWPs were Tigris HIV RNA 5.5 days, s 201 (1:6) HIV RNA 7.4 days, GenScreen Plus p24/anti-HIV 17.8 days, PRISM anti-HIV 19.0 days, Tigris HBV DNA 20.6 days, s 201 (1:6) HBV DNA 22.6 days, Bio-Rad hepatitis B surface antigen (HBsAg) 37.8 days, and PRISM HBsAg 35.5 days. At estimated 50 percent NAT seroconversion rates, s 201 (1:6) and Tigris showed mean window-period reduction times (WPRTs) of 30.5 to 35.5 days to hepatitis C virus antibody (anti-HCV) assays, 10.4 to 13.5 days to anti-HIV, or combination p24/anti-HIV assays and 12.8 to 17.2 days to HBsAg assays.Tigris ID-NAT detected HIV RNA 2 days earlier than s 201 MP6-NAT, but the difference in sensitivity between the two NAT systems was not significant in HBV seroconversion panels. Insufficient seroconversion samples were available for reliable modeling of WPRT in early HCV infection, but 1.4 to 2.0 days could be predicted by translating analytical sensitivity data. Both multiplex NAT systems demonstrate significant WPRTs compared to (combined) antigen and antibody assays.