title: Evaluation of the Abbott m2000rt RealTime HIV-1 assay with manual sample preparation compared with the ROCHE COBAS AmpliPrep/AMPLICOR HIV-1 MONITOR v1.5 using specimens from East Africa.
abstract: The performance of the Abbott m2000rt RealTime HIV-1 assay (RealTime HIV-1) with manual sample preparation was compared against the ROCHE COBAS AmpliPrep/AMPLICOR HIV-1 MONITOR Test v1.5 (CAP/CA HIV-1) using samples collected from 100 donors infected with HIV and 20 donors not infected with HIV in northern Tanzania where HIV-1 subtypes A, C, D, and their recombinant forms predominate. The RealTime HIV-1 appeared to have more within-run variability at high HIV-1 RNA concentrations, but total assay variability over the dynamic range tested was within the manufacturer's claim of <0.3 SD copies/mL. Accuracy studies showed 100% concordance for positive and negative values. When continuous values were examined, CAP/CA HIV-1 yielded higher values than the RealTime HIV-1 at higher nominal HIV-1 RNA concentrations. The RealTime HIV-1 assay showed excellent linearity between 2.5 and 7.0 log copies/mL. Of negative samples, 100% showed negative results, and >95% of samples with nominal concentrations of 40 copies/mL were detected at > or = 40 copies/mL by RealTime HIV-1. Manual sample preparation may contribute to higher total assay variability. This study suggests that the Abbott m2000rt RealTime HIV-1 assay with manual sample preparation is an acceptable and feasible alternative to the conventional ROCHE COBAS AmpliPrep/AMLICOR HIV-1 Monitor v1.5 assay and that the RealTime HIV-1 assay performs well on samples from East Africa.
authors.affiliation: Division of Infectious Diseases and International Health, Department of Medicine, Duke University Medical Center, Box 102359, Durham, NC 27710, USA. crump017@mc.duke.edu
authors.forename: John A
authors.initials: JA
authors.lastname: Crump
authors.forename: Lesley E
authors.initials: LE
authors.lastname: Scott
authors.forename: Emma
authors.initials: E
authors.lastname: Msuya
authors.forename: Anne B
authors.initials: AB
authors.lastname: Morrissey
authors.forename: Ekyafyose E
authors.initials: EE
authors.lastname: Kimaro
authors.forename: John F
authors.initials: JF
authors.lastname: Shao
authors.forename: Wendy S
authors.initials: WS
authors.lastname: Stevens
mesh_terms: D001782:Blood Donors; D005838:Genotype; D015658:HIV Infections / Q000175:diagnosis* / Q000821:virology; D015497:HIV-1 / Q000145:classification / Q000235:genetics / Q000302:isolation & purification / Q000502:physiology; D006801:Humans; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D012367:RNA, Viral / Q000097:blood; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000379:methods*; D013636:Tanzania; D019562:Viral Load
chemical_list: D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic