Comparison of the analytical and operational performance of two viral nucleic acid test blood screening systems: Procleix Tigris and cobas s 201
Comparison of the analytical and operational performance of two viral nucleic acid test blood screening systems: Procleix Tigris and cobas s 201
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DOI：
10.1111/j.1537-2995.2008.01965.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
在法国血液局的4个筛选实验室中，比较了两种自动三型乙型肝炎病毒（HBV）、丙型肝炎病毒（HCV）和人类免疫缺陷病毒（HIV）核酸检测（NAT）系统的操作和分析性能。两个实验室以个体捐赠（ID）的形式评估Procleix Tigris系统（Chiron/Gen-Probe），两个站点在6个捐赠的迷你池（MPs）上使用cobas s 201系统（罗氏分子系统）。比较两种方法的分析灵敏度、特异度和操作性能。在不同基因型的标准稀释板中，HCV RNA对MP-NAT相对敏感性因子的ID在8.7 - 21.9之间，HIV RNA在6.7 - 14.8之间，HBV DNA在0.71 - 11.6之间。Tigris对HIV O组样本的灵敏度是cobas s 201的800倍（1:6），但对cobas s 201采集的HIV-2样本的灵敏度不及HIV-1 M组样本。在2011年5月对10520份Tigris和1444个测试池进行初步筛选后，两种NAT系统的特异性均为99.9%，但在重复和池分辨率测试算法后达到100%。当每日工作负载超过400个捐赠时，cobas上的池测试协议的吞吐量更高。在检测HCV RNA和HIV RNA稀释板时，Tigris ID-NAT格式明显比cobas s 201 MP-NAT格式更敏感，但尽管s 201稀释系数为1:6，但对某些HBV基因型板的敏感性差异不显著。两个NAT系统都表现出可接受的操作性能，但对于日常使用，需要进一步提高系统可靠性。
The operational and analytical performance of two automated triplex hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) nucleic acid test (NAT) systems were compared in four screening laboratories of the French Blood Service.Two laboratories evaluated the Procleix Tigris system (Chiron/Gen-Probe) in individual donation (ID) format and two sites used the cobas s 201 system (Roche Molecular Systems) on minipools (MPs) of six donations. The analytical sensitivity, the specificity, and operational performance were compared.The ID to MP-NAT relative sensitivity factors in standard dilution panels of different genotypes varied between 8.7 and 21.9 for HCV RNA, 6.7 and 14.8 for HIV RNA, and 0.71 and 11.6 for HBV DNA. Tigris was 800-fold more sensitive than cobas s 201 (1:6) for a HIV group O sample, but did not detect the HIV-2 sample picked up by cobas s 201 with equal sensitivity as the HIV-1 group M samples. The specificity of both NAT systems after initial screening of 10,520 donations with Tigris and 1444 test pools on s 201 was 99.9 percent for both systems, but reached 100 percent after the repeat and pool resolution test algorithms. A higher throughput of the pool test protocol on cobas s 201 became apparent when the daily workload was more than 400 donations.Tigris ID-NAT format was significantly more sensitive than cobas s 201 MP-NAT in detecting HCV RNA and HIV RNA dilution panels, but despite the 1:6 dilution factor in s 201 the difference in sensitivity was not significant for some of the HBV genotype panels. Both NAT systems demonstrated acceptable operational performance, but for routine use further improvement in system reliability is desirable.