title: Comparative analysis of HIV-1 viral load assays on subtype quantification: Bayer Versant HIV-1 RNA 3.0 versus Roche Amplicor HIV-1 Monitor version 1.5.
abstract: Quantification of HIV-1 subtypes is essential for appropriate clinical management. Whereas viral load assays were initially developed to accurately quantify subtype B, the recent worldwide spread of non-B subtypes and the introduction of treatment programs in regions with non-B subtypes have prompted adaptations of these assays. The Bayer Versant HIV-1 RNA 3.0 Assay (branched DNA [bDNA] 3.0) and the Roche Amplicor HIV-1 Monitor version 1.5 (Amplicor 1.5) assays are reported to quantify all subtypes in group M; however, evaluation of performance characteristics remains limited. In this study, we evaluated the accuracy and reliability of bDNA 3.0 and Amplicor 1.5 on multiple serially diluted viral isolates from HIV-1 group M, subtypes A through F. Testing was conducted on both assay systems in two independent laboratories. Comparative pansubtype quantification from regression analysis showed that quantification by bDNA 3.0 was approximately 0.3 log-fold lower than that by Amplicor 1.5. Comparative pansubtype accuracy analysis showed data points more closely distributed about their respective regression lines and thus showing greater reliability by bDNA 3.0 than by Amplicor 1.5.
authors.affiliation: Department of Laboratory Medicine, University of California at San Francisco and Clinical Laboratories at San Francisco General Hospital, San Francisco, California 94110, USA. elbeik@itsa.ucsf.edu
authors.forename: Tarek
authors.initials: T
authors.lastname: Elbeik
authors.forename: W Gregory
authors.initials: WG
authors.lastname: Alvord
authors.forename: Rapee
authors.initials: R
authors.lastname: Trichavaroj
authors.forename: Mark
authors.initials: M
authors.lastname: de Souza
authors.forename: Robin
authors.initials: R
authors.lastname: Dewar
authors.forename: Arthur
authors.initials: A
authors.lastname: Brown
authors.forename: David
authors.initials: D
authors.lastname: Chernoff
authors.forename: Nelson L
authors.initials: NL
authors.lastname: Michael
authors.forename: Patricia
authors.initials: P
authors.lastname: Nassos
authors.forename: Keith
authors.initials: K
authors.lastname: Hadley
authors.forename: Valerie L
authors.initials: VL
authors.lastname: Ng
mesh_terms: D021121:Branched DNA Signal Amplification Assay; D015658:HIV Infections / Q000821:virology; D015497:HIV-1 / Q000145:classification* / Q000235:genetics / Q000502:physiology*; D006801:Humans; D012367:RNA, Viral / Q000097:blood; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D020133:Reverse Transcriptase Polymerase Chain Reaction; D019562:Viral Load
chemical_list: D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic