两种乙型肝炎病毒、丙型肝炎病毒（HCV）和人类免疫缺陷病毒（HIV）核酸检测系统相对于血清学转换检测组中乙型肝炎表面抗原、抗-HCV、抗-HIV及p24/抗-HIV联合检测的敏感性。

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.

作者信息

Assal Azzedine, Barlet Valérie, Deschaseaux Marie, Dupont Isabelle, Gallian Pierre, Guitton Cathy, Morel P, van Drimmelen Harry, David Bernard, Lelie Nico, De Micco Philippe

机构信息

Etablissement Français du Sang , La Plaine Saint Denis, France.

出版信息

Transfusion. 2009 Feb;49(2):301-10. doi: 10.1111/j.1537-2995.2008.01966.x.

DOI:10.1111/j.1537-2995.2008.01966.x

PMID:19389212

Abstract

BACKGROUND

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.

STUDY DESIGN AND METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

摘要

背景

与血清学检测相比，准确确定个体捐赠（ID）核酸检测或混合样本（MP）核酸检测的感染窗口期（IWP）对于残留风险评估至关重要。

研究设计与方法

通过对每个标志物的五个血清转化样本组进行四次重复检测，评估了ID - NAT形式使用的Procleix Tigris系统（Gen - Probe/Chiron）和应用于1:6稀释样本以模拟六混合样本（MP6）核酸检测（NAT）的cobas s 201（罗氏分子系统公司）的相对灵敏度。基于bDNA 3.0检测确定的病毒血症在上升阶段的对数线性增加进行数学分析，能够估计人类免疫缺陷病毒（HIV）和乙型肝炎病毒（HBV）检测的IWP。

结果

平均IWP分别为：Tigris HIV RNA为5.5天，s 201（1:6）HIV RNA为7.4天，GenScreen Plus p24/抗 - HIV为17.8天，PRISM抗 - HIV为19.0天，Tigris HBV DNA为20.6天，s 201（1:6）HBV DNA为22.6天，伯乐乙肝表面抗原（HBsAg）为37.8天，PRISM HBsAg为35.5天。在估计的50% NAT血清转化率时，s 201（1:6）和Tigris显示，与丙型肝炎病毒抗体（抗 - HCV）检测相比，平均窗口期缩短时间（WPRT）为30.5至35.5天，与抗 - HIV或联合p24/抗 - HIV检测相比为10.4至13.5天，与HBsAg检测相比为12.8至17.2天。

结论

Tigris ID - NAT检测HIV RNA比s 201 MP6 - NAT早2天，但在HBV血清转化样本组中，两种NAT系统的灵敏度差异不显著。在丙型肝炎病毒早期感染中，没有足够的血清转化样本用于可靠的WPRT建模，但通过转换分析灵敏度数据可预测1.4至2.0天。与（联合）抗原和抗体检测相比，两种多重NAT系统均显示出显著的WPRT。