title: Comparison of the Generic HIV Viral Load assay with the Amplicor HIV-1 monitor v1.5 and Nuclisens HIV-1 EasyQ v1.2 techniques for plasma HIV-1 RNA quantitation of non-B subtypes: the Kesho Bora preparatory study.
abstract: 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, Amplicor v1.5 and Nuclisens EasyQ 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 A1, 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 assay were not detected by either the Amplicor (n=7) or EasyQ (n=2) test. One strain (0.6%) was missed with the Generic HIV Viral Load 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, as compared to Amplicor v1.5 (mean differences, +0.33 and +0.67 log(10) copies/ml; P=0.0004 and P=0.002, respectively). The Generic HIV Viral Load assay accurately quantified the majority of the non-B HIV-1 subtypes assessed in this study. Due to its low cost (approximately 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.
authors.affiliation: Laboratoire de Virologie, Centre Muraz, Bobo-Dioulasso, Burkina Faso. franrouet@yahoo.fr
authors.forename: François
authors.initials: F
authors.lastname: Rouet
authors.forename: Vincent
authors.initials: V
authors.lastname: Foulongne
authors.forename: Johannes
authors.initials: J
authors.lastname: Viljoen
authors.forename: Kim
authors.initials: K
authors.lastname: Steegen
authors.forename: Pierre
authors.initials: P
authors.lastname: Becquart
authors.forename: Diane
authors.initials: D
authors.lastname: Valéa
authors.forename: Sivapragashini
authors.initials: S
authors.lastname: Danaviah
authors.forename: Michel
authors.initials: M
authors.lastname: Segondy
authors.forename: Chris
authors.initials: C
authors.lastname: Verhofstede
authors.forename: Philippe
authors.initials: P
authors.lastname: Van de Perre
mesh_terms: D002050:Burkina Faso; D005260:Female; D015658:HIV Infections / Q000821:virology*; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D007630:Kenya; D010949:Plasma / Q000821:virology*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000821:virology*; D012367:RNA, Viral / Q000097:blood*; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D013019:South Africa; D013223:Statistics as Topic; D019562:Viral Load / Q000191:economics / Q000379:methods*
chemical_list: D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic