title: Analytical characteristics and comparative evaluation of Aptima HIV-1 Quant Dx assay with Ampliprep/COBAS TaqMan HIV-1 test v2.0.
abstract: Quantitation of HIV-RNA is critically important for diagnosis, prognosis, treatment, monitoring and assessment of infectivity in HIV-1 infection. The objective of this study was to assess performance characteristics of the Aptima HIV-1 Quant Dx assay (Aptima), a new transcription mediated amplification (TMA), fully integrated and automated assay from Hologic Inc., San Diego, CA, USA. The analytical sensitivity, analytical specificity, precision and detection of HIV-1 subtypes were tested based on commercially available international standards or panels. A selected group of 244 anti-HIV-1 (+) plasma samples was used for comparison with Roche COBAS Ampliprep/COBAS TaqMan HIV- 1 test v2.0 (Roche CAP/CTM), (Roche Molecular Systems, Pleasanton, CA).
  
  
  
  The 50 and 95 % limit of detection were estimated at 4.9 (95 % CI 3.9-5.7) and 17.6 (15.2-21.2) IU/mL respectively. The specificity was found 99.83 (99.06-99.97) %. The standard deviations and coefficient of variations for panels with 50 and 100 copies/mL (1.7 and 2 log copies/mL) were 0.14 log copies/mL (8.67 %CV) and 0.18 log copies/mL (9.91 %CV) respectively. The detection rate for Aptima and Roche assays was 220/244 (90.2 %) and 217/244 (88.9 %) respectively.
  
  
  
  The Aptima assay is a sensitive, specific, precise and accurate test for measuring HIV-1 viral loads and for the detection of HIV-1 infections.
authors: Department of Hygiene, Epidemiology and Medical Statistics, Medical School, National and Kapodistrian University of Athens, Mikras Asias 75, GR-11527, Athens, Greece. ahatzak@med.uoa.gr.|Hellenic Scientific Society for the Study of AIDS and Sexually Transmitted Diseases, Athens, Greece. ahatzak@med.uoa.gr.|Department of Hygiene, Epidemiology and Medical Statistics, National Retrovirus Reference Center, National and Kapodistrian University of Athens Medical School, Mikras Asias 75, GR-11527, Athens, Greece. ahatzak@med.uoa.gr.
authors: Angelos
authors: A
authors: Hatzakis
authors: Department of Hygiene, Epidemiology and Medical Statistics, Medical School, National and Kapodistrian University of Athens, Mikras Asias 75, GR-11527, Athens, Greece.
authors: Helen
authors: H
authors: Papachristou
authors: Hologic Inc., 10210 Genetic Center Drive, San Diego, CA, 92121, USA.
authors: Sangeetha J
authors: SJ
authors: Nair
authors: Hologic Inc., 10210 Genetic Center Drive, San Diego, CA, 92121, USA.
authors: Jacqueline
authors: J
authors: Fortunko
authors: Hologic Inc., 10210 Genetic Center Drive, San Diego, CA, 92121, USA.
authors: Tracy
authors: T
authors: Foote
authors: Hologic Inc., 10210 Genetic Center Drive, San Diego, CA, 92121, USA.
authors: HeeCheol
authors: H
authors: Kim
authors: Hologic Inc., 10210 Genetic Center Drive, San Diego, CA, 92121, USA.
authors: Tashi L
authors: TL
authors: Peling
authors: Hologic Inc., 10210 Genetic Center Drive, San Diego, CA, 92121, USA.
authors: Andrew J
authors: AJ
authors: Worlock
mesh_terms: D015658:HIV Infections / Q000175:diagnosis* / Q000821:virology*; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D012367:RNA, Viral / Q000032:analysis* / Q000235:genetics; D012680:Sensitivity and Specificity; D019562:Viral Load / Q000379:methods*
chemical_list: D012367:RNA, Viral