Rush Medical College, Department of Immunology and Microbiology, Chicago, Illinois, USA.
J Clin Microbiol. 2012 Aug;50(8):2737-47. doi: 10.1128/JCM.00578-12. Epub 2012 Jun 12.
HIV-1 RNA quantitation continues to be extremely important for monitoring patients infected with HIV-1, and a number of assays have been utilized for this purpose. Differences in assay performance with respect to log(10) recovery and HIV-1 subtype specificity have been well documented for commercially available assays, although comparisons are usually limited to one or two assay platforms. Two new FDA-approved assays, the Roche Cobas AmpliPrep/Cobas TaqMan HIV-1 test (RT) and the Abbott RealTime HIV-1 assay (AR), that utilize real-time PCR have replaced previous HIV-1 RNA platforms. Inadequate detection of some strains of HIV-1 resulted in the addition of a new primer/probe set and the introduction of a second version of the RT assay. In this study, comparisons of assay performance between the different FDA-approved HIV-1 RNA assay platforms (both new and existing) were performed by using validation data that included both well-characterized virus stock and locally collected clinical samples. Laboratories across diverse geographical regions performed the validation testing and submitted data to the Virology Quality Assurance program (VQA) for analysis. Correlation values for clinical sample testing varied across the assay platforms (r = 0.832 to 0.986), and average log(10) recoveries for HIV-1 RNA controls (compared to the nominal value) ranged from -0.215 to 0.181. These data demonstrate the need for use of one assay platform for longitudinal patient monitoring, but the data also reinforce the notion that no one assay is superior and that testing across platforms may be required for discordance reconciliation.
HIV-1 RNA 定量仍然是监测 HIV-1 感染患者的极其重要的手段，为此已经使用了许多检测方法。虽然比较通常仅限于一两个检测平台，但已有大量文献记录了市售检测方法在对数（10）恢复和 HIV-1 亚型特异性方面的性能差异。两种新的获得 FDA 批准的检测方法，罗氏 Cobas AmpliPrep/Cobas TaqMan HIV-1 测试（RT）和雅培 RealTime HIV-1 assay（AR），都利用了实时 PCR，已经取代了以前的 HIV-1 RNA 平台。由于无法充分检测到某些 HIV-1 毒株，因此添加了新的引物/探针组，并对 RT 检测方法进行了第二次修订。在这项研究中，通过使用包括经过充分鉴定的病毒株和当地采集的临床样本在内的验证数据，对不同 FDA 批准的 HIV-1 RNA 检测方法平台（新旧平台）的性能进行了比较。来自不同地理位置的实验室进行了验证测试，并将数据提交给病毒学质量保证计划（VQA）进行分析。临床样本检测的相关性值在不同的检测平台之间有所不同（r = 0.832 至 0.986），HIV-1 RNA 对照的平均对数（10）回收率（与标称值相比）范围从-0.215 到 0.181。这些数据表明需要使用一种检测平台进行纵向患者监测，但数据也强化了一个观点，即没有一种检测方法是优越的，可能需要跨平台进行检测以解决不一致性。
