In-house HIV-1 RNA real-time RT-PCR assays: principle, available tests and usefulness in developing countries

Expert Rev Mol Diagn. 2008 Sep;8(5):635-50. doi: 10.1586/14737159.8.5.635.

Abstract

The principle of currently available licensed HIV-1 RNA assays is based on real-time technologies that continuously monitor the fluorescence emitted by the amplification products. Besides these assays, in-house quantitative (q) real-time reverse transcription (RT)-PCR (RT-qPCR) tests have been developed and evaluated particularly in developing countries, for two main reasons. First, affordable and generalized access to HIV-1 RNA viral load is urgently needed in the context of expected universal access to prevention and antiretroviral treatment programs in these settings. Second, since many non-B subtypes, circulating recombinant forms and unique recombinant forms circulate in these areas, in-house HIV-1 RNA RT-qPCR assays are ideal academic tools to thoroughly evaluate the impact of HIV-1 genetic diversity on the accuracy of HIV-1 RNA quantification, as compared with licensed techniques. To date, at least 15 distinct in-house assays have been designed. They differ by their chemistry and the HIV-1 target sequence (located in gag, Pol-IN or LTR gene). Analytical performances of the tests that have been extensively evaluated appear at least as good as (or even better than) those of approved assays, with regard to HIV-1 strain diversity. Their clinical usefulness has been clearly demonstrated for early diagnosis of pediatric HIV-1 infection and monitoring of highly active antiretroviral therapy efficacy. The LTR-based HIV-1 RNA RT-qPCR assay has been evaluated by several groups under the auspices of the Agence Nationale de Recherches sur le SIDA et les hépatites virales B et C. It exists now as a complete standardized commercial test.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • DNA Primers / genetics
  • Developing Countries*
  • HIV-1 / genetics*
  • Humans
  • RNA, Viral / analysis*
  • RNA, Viral / genetics
  • Reverse Transcriptase Polymerase Chain Reaction / methods*
  • Time Factors

Substances

  • DNA Primers
  • RNA, Viral