Comparison of the Generic HIV Viral Load (R) assay with the Amplicor (TM) HIV-1 Monitor v1.5 and Nuclisens HIV-1 EasyQ (R) v1.2 techniques for plasma HIV-1 RNA quantitation of non-B subtypes: The Kesho Bora preparatory study

摘要

The implementation of cost effective HIV-1 RNA quantitation assays in resource-poor settings is Of paramount importance for monitoring HV-1 infection. A study comparing the analytical performance of three HIV-1 RNA assays (Generic HIV Viral Load (R), Amplicor (TM) v1.5 and Nuclisens EasyQ (R) v1.2) was performed on 160 plasma samples from 160 consecutive antiretroviral treatment naive HIV-1-infected pregnant women assessed for eligibility in the Kesho Bora trial aimed at prevention of mother-to-child transmission of HIV-1 in three African countries (Burkina Faso, Kenya and South Africa). Correlation and agreement of results of the three assays were assessed for plasma HIV-1 RNA quantitation in specimens harbouring mainly sub-subtype All, subtype C, and circulating recombinant form (CRF) 02_AG and CRF06_cpx.Good degrees of correlation and agreement were observed between these HIV-1 RNA assays. However, nine (9/160, 5.6%) strains detectable with the Generic HIV Viral Load (R) assay were not detected by either the Amplicor (TM) (n = 7) or EasyQ (R) (n = 2) test. One strain (0.6%) was missed with the Generic HIV Viral Load (R) assay. Further, concordantly positive plasma samples harbouring CRF02_AG and CRF06_cpx yielded significantly higher HIV-1 RNA concentrations when tested by Generic HIV Viral Load (R), as compared to Amplicor (TM) v1.5 (mean differences, +033 and +0.67 log(10) copies/ml; P = 0.0004 and P = 0.002, respectively). The Generic HIV Viral Load (R) assay accurately quantified the majority of the non-B HIV-1 subtypes assessed in this study. Due to its low cost (similar to 10 US $/test), this assay performed with open real-time PCR instruments is now used routinely in the Kesho Bora trial and may be recommended in other African settings.