Germer Jeffrey J, Majewski David W, Yung Billy, Mitchell P Shawn, Yao Joseph D C
Division of Clinical Microbiology, Hilton 4-60, Mayo Clinic, 200 First Street S.W., Rochester, MN 55905, USA.
J Clin Microbiol. 2006 Feb;44(2):318-23. doi: 10.1128/JCM.44.2.318-323.2006.
The Invader 1.0 assay (Invader HCV Genotyping Assay, version 1.0; Third Wave Technologies, Inc., Madison, WI) has been developed for the rapid differentiation of hepatitis C virus (HCV) genotypes 1 to 6 based on sequence variation within the HCV 5' noncoding (NC) region. In the present study, we evaluated the compatibility of Invader 1.0 with the COBAS MONITOR (COBAS AMPLICOR HCV MONITOR Test, version 2.0; Roche Molecular Systems, Inc., Branchburg, NJ), COBAS AMPLICOR (COBAS AMPLICOR Hepatitis C Virus Test, version 2.0; Roche Molecular Systems, Inc.), and COBAS TaqMan (COBAS TaqMan HCV Test; Roche Molecular Systems, Inc.) assays. The minimum HCV RNA titers required for successful HCV genotyping (>/=90% success rate) were 1,000 IU/ml for COBAS MONITOR, 100 IU/ml for COBAS AMPLICOR, and 10 IU/ml for COBAS TaqMan. Invader 1.0 results obtained from unpurified COBAS TaqMan amplification products of 111 retrospectively selected clinical serum specimens (genotypes 1 to 6, with virus titers ranging from 15.1 to 2.1 x 10(7) IU/ml) showed 98% concordance with results obtained from the TRUGENE HCV 5' NC Genotyping Kit (Bayer HealthCare LLC, Tarrytown, NY), used in conjunction with COBAS AMPLICOR. Although the assay is sensitive, accurate, and easy to perform, additional optimization of the Invader 1.0 interpretive software (Invader Data Analysis Worksheet) may be necessary to reduce potential misidentification of HCV genotypes in low-titer specimens. In summary, Invader 1.0 is compatible with a variety of commercially available PCR-based HCV 5' NC region amplification assays and is suitable for routine HCV genotyping in clinical laboratories.
入侵1.0检测法（入侵丙型肝炎病毒基因分型检测法，版本1.0；第三波技术公司，威斯康星州麦迪逊）已被开发用于基于丙型肝炎病毒（HCV）5'非编码（NC）区域内的序列变异对1至6型HCV基因型进行快速区分。在本研究中，我们评估了入侵1.0检测法与COBAS MONITOR（COBAS AMPLICOR HCV MONITOR检测法，版本2.0；罗氏分子系统公司，新泽西州布兰奇堡）、COBAS AMPLICOR（COBAS AMPLICOR丙型肝炎病毒检测法，版本2.0；罗氏分子系统公司）以及COBAS TaqMan（COBAS TaqMan HCV检测法；罗氏分子系统公司）检测法的兼容性。成功进行HCV基因分型（成功率≥90%）所需的最低HCV RNA滴度，对于COBAS MONITOR为1000 IU/ml，对于COBAS AMPLICOR为100 IU/ml，对于COBAS TaqMan为10 IU/ml。从111份回顾性选择的临床血清标本（基因型1至6，病毒滴度范围为15.1至2.1×10⁷ IU/ml）的未纯化COBAS TaqMan扩增产物获得的入侵1.0检测结果，与使用TRUGENE HCV 5' NC基因分型试剂盒（拜耳医疗保健有限责任公司，纽约州塔里敦）并结合COBAS AMPLICOR获得的结果显示出98%的一致性。尽管该检测法灵敏、准确且易于操作，但可能需要对入侵1.0解释软件（入侵数据分析工作表）进行额外优化，以减少低滴度标本中HCV基因型潜在的错误鉴定。总之，入侵1.0检测法与多种基于PCR的市售HCV 5' NC区域扩增检测法兼容，适用于临床实验室的常规HCV基因分型。
