title: Evaluation of performance across the dynamic range of the Abbott RealTime HIV-1 assay as compared to VERSANT HIV-1 RNA 3.0 and AMPLICOR HIV-1 MONITOR v1.5 using serial dilutions of 39 group M and O viruses.
abstract: Performance of the Abbott m2000 instrument system and the Abbott RealTime HIV-1 assay was evaluated using a panel of 37 group M (subtypes A-D, F, G, CRF01_AE, CRF02_AG and unique recombinant forms) and 2 group O virus isolates. Testing was performed on 273 sample dilutions and compared to VERSANT HIV-1 RNA 3.0 (bDNA) and AMPLICOR HIV-1 MONITOR v1.5 (Monitor v1.5) test results. RealTime HIV-1, bDNA, and Monitor v1.5 tests quantified 87%, 78%, and 81% of samples, respectively. RealTime HIV-1 detected an additional 31 samples at < 40 copies/mL. For group M, RealTime HIV-1 dilution profiles and viral loads were highly correlated with bDNA and Monitor v1.5 values; 87% and 89% of values were within 0.5 log(10) copies/mL. In contrast, the group O viruses were not detected by Monitor v1.5 and were substantially underquantified by approximately 2 log(10) copies/mL in bDNA relative to the RealTime HIV-1 assay. Sequence analysis revealed that RealTime HIV-1 primer/probe binding sites are highly conserved and exhibit fewer nucleotide mismatches relative to Monitor v1.5. The automated m2000 system and RealTime HIV-1 assay offer the advantages of efficient sample processing and throughput with reduced "hands-on" time while providing improved sensitivity, expanded dynamic range and reliable quantification of genetically diverse HIV-1 strains.
authors.affiliation: Abbott Diagnostics, AIDS Research and Retrovirus Discovery, D-09NG, Bldg. AP20, 100 Abbott Park Road, Abbott Park, IL 60064-6015, USA.
authors.forename: Priscilla
authors.initials: P
authors.lastname: Swanson
authors.forename: Shihai
authors.initials: S
authors.lastname: Huang
authors.forename: Klara
authors.initials: K
authors.lastname: Abravaya
authors.forename: Carmen
authors.initials: C
authors.lastname: de Mendoza
authors.forename: Vincent
authors.initials: V
authors.lastname: Soriano
authors.forename: Sushil G
authors.initials: SG
authors.lastname: Devare
authors.forename: John
authors.initials: J
authors.lastname: Hackett
mesh_terms: D001331:Automation; D021121:Branched DNA Signal Amplification Assay / Q000379:methods*; D005069:Evaluation Studies as Topic; D014644:Genetic Variation; D015658:HIV Infections / Q000821:virology*; D015497:HIV-1 / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D012367:RNA, Viral / Q000032:analysis*; D011933:Reagent Kits, Diagnostic; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000379:methods*; D019562:Viral Load
chemical_list: D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic