Taylor Ninon, Schmid Ilse, Egle Alexander, Greil Richard, Patsch Wolfgang, Oberkofler Hannes
Third Medical Department, Paracelsus Medical University and Universitätsklinikum Salzburg, Salzburg, Austria.
Antivir Ther. 2009;14(8):1189-93. doi: 10.3851/IMP1427.
HIV type-1 (HIV-1) genetic diversity poses a challenge for the development of diagnostic tests based on nucleic acid amplification, which can be overcome, at least in part, by targeting multiple genomic regions. The new Roche Diagnostics COBAS TaqMan (CTM) HIV-1 v2.0 assay uses multiplex real-time PCR detection of sequences in the long terminal repeat and gag regions within the HIV-1 genome.
We conducted initial comparative testing of HIV-1 viral load values in plasma samples from HIV-1-infected individuals using the Abbott RealTime HIV-1 (Abbott RT HIV-1), and the Roche CTM v1.0 and CTM v2.0 real-time PCR amplification systems, with a particular focus on patients previously undetectable or underestimated with the CTM v1.0 assay.
The new Roche CTM v2.0 assay showed excellent agreement with the other two assays over a wide dynamic range (r=0.9685). The assay also allowed accurate determination of viral load levels in individuals infected with HIV-1 isolates that were found falsely negative or underestimated with the Roche CTM v1.0 assay because of mutations within the gag region.
The reliability and accuracy of the CTM v2.0 assay is similar to the Abbott RT HIV-1 assay. The implementation of a multiplex real-time PCR approach in the CTM v2.0 is a significant improvement in viral load testing in comparison with the CTM v1.0 assay.
1型人类免疫缺陷病毒（HIV-1）的基因多样性对基于核酸扩增的诊断测试的开发构成挑战，通过靶向多个基因组区域至少可以部分克服这一挑战。罗氏诊断公司新的COBAS TaqMan（CTM）HIV-1 v2.0检测法采用多重实时PCR检测HIV-1基因组中长末端重复序列和gag区域的序列。
我们使用雅培实时HIV-1（Abbott RT HIV-1）、罗氏CTM v1.0和CTM v2.0实时PCR扩增系统，对HIV-1感染个体血浆样本中的HIV-1病毒载量值进行了初步比较测试，特别关注先前使用CTM v1.0检测法无法检测到或检测值被低估的患者。
新的罗氏CTM v2.0检测法在很宽的动态范围内与其他两种检测法显示出极好的一致性（r=0.9685）。该检测法还能够准确测定感染了因gag区域内突变而被罗氏CTM v1.0检测法误判为阴性或检测值被低估的HIV-1毒株的个体的病毒载量水平。
CTM v2.0检测法的可靠性和准确性与雅培实时HIV-1检测法相似。与CTM v1.0检测法相比，CTM v2.0中采用的多重实时PCR方法是病毒载量检测的一项重大改进。
