Margaritis Angelo R, Brown Stewart M, Seed Clive R, Kiely Philip, D'Agostino Bruno, Keller Anthony J
Australian Red Cross Blood Service-Enterprise, 97 Great Eastern Highway, Rivervale, Western Australia 6103.
Transfusion. 2007 Oct;47(10):1783-93. doi: 10.1111/j.1537-2995.2007.01343.x.
Recently developed nucleic acid testing (NAT) assays incorporating simultaneous detection of human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) have made HBV NAT screening more feasible for blood services. This study compared the performance of two "multiplex" NAT assays and their automated testing platforms.
The HBV NAT yield rate was estimated by testing 10,397 Hong Kong (HK) donor samples concurrently on the PROCLEIX ULTRIO (Ultrio) assay as individual donor samples with the TIGRIS and on the cobas TaqScreen multiplex (cobas MPX) test in pools of 6 with the cobas s 201. Analytical sensitivity was assessed by probit analysis of diluted international standards and operational performance was compared.
Each system detected two different HBV NAT yield samples for a combined rate of 0.04 percent. One additional sample was reactive on the cobas MPX test but remained unresolved. The 95 percent detection limits for HIV-1, HBV, and HCV were 42.2, 12.2, and 2.0 IU per mL, respectively, for Ultrio and 50.5, 8.4, and 6.0 IU per mL for the cobas MPX. The invalid test and failed run rates were 0.05 and 2.92 percent, respectively, for the TIGRIS and 2.39 and 5.53 percent for the cobas s 201.
Clinical sensitivity for HBV in HK blood donors was equivalent, as was the analytical sensitivity for HIV-1 and HBV; however, the Ultrio assay had a higher analytical sensitivity for HCV. Despite a shorter downtime and mean time of repair for the cobas s 201, the TIGRIS demonstrated better overall operational performance.
最近开发的同时检测人类免疫缺陷病毒（HIV）、丙型肝炎病毒（HCV）和乙型肝炎病毒（HBV）的核酸检测（NAT）检测方法，使血液服务中HBV NAT筛查变得更加可行。本研究比较了两种“多重”NAT检测方法及其自动化检测平台的性能。
通过在TIGRIS上以单个供体样本的形式对10397份香港（HK）供体样本进行PROCLEIX ULTRIO（Ultrio）检测，并在cobas s 201上以6份样本为一组进行cobas TaqScreen多重（cobas MPX）检测，来估计HBV NAT检出率。通过对稀释的国际标准品进行概率分析评估分析灵敏度，并比较操作性能。
每个系统检测出两个不同的HBV NAT阳性样本，合并检出率为0.04%。另外有一个样本在cobas MPX检测中呈反应性，但仍未得到解决。Ultrio检测中HIV-1、HBV和HCV的95%检测限分别为每毫升42.2、12.2和2.0国际单位，cobas MPX分别为每毫升50.5、8.4和6.0国际单位。TIGRIS的无效检测率和运行失败率分别为0.05%和2.92%，cobas s 201分别为2.39%和5.53%。
香港献血者中HBV的临床灵敏度相当，HIV-1和HBV的分析灵敏度也相当；然而，Ultrio检测对HCV的分析灵敏度更高。尽管cobas s 201的停机时间和平均修复时间较短，但TIGRIS的整体操作性能更好。
