title: Comparison of the Gen-Probe Aptima HIV-1 and Abbott HIV-1 qualitative assays with the Roche Amplicor HIV-1 DNA assay for early infant diagnosis using dried blood spots.
abstract: BACKGROUND
  The current gold standard for infant diagnosis of HIV-1 is the Roche Amplicor Qualitative DNA assay, but it is being phased out.
  
  
  OBJECTIVE
  Compare the Abbott qualitative assay and the Gen-Probe Aptima assay to the gold standard Roche DNA assay using dried blood spots (DBS).
  
  
  METHODS
  The Gen-Probe Aptima and Abbott qualitative HIV-1 assays were compared to the Roche DNA assay for early infant diagnosis. Specificity and sensitivity were determined for the three assays using DBS from 50 HIV-exposed uninfected infants and 269 HIV-1 infected adults from North Carolina, respectively. All of the negative and 151 of the positive DBS had valid results on the 3 different assays, and an additional 118 positive DBS had valid results on the Roche DNA and Aptima assays.
  
  
  RESULTS
  All three assays were very specific. The Roche DNA assay was the most sensitive (96.7%) over a wide range of HIV PVL, including samples with PVL<400 copies/ml. Restricted to samples with PVL>400 copies/ml, the Gen-Probe Aptima assay had sensitivity (96.5%) comparable to the Roche DNA assay (98.8%). The Abbott Qualitative assay was the least sensitive and only had sensitivity above 95% among samples with PVL over 1000 copies/ml.
  
  
  CONCLUSIONS
  The Abbott HIV-1 Qualitative assay was not as sensitive as the comparator assays, so it would not be a useful replacement assay, especially for infants taking antiretroviral prophylaxis. The Gen-Probe Aptima assay is an adequate replacement option for infant diagnosis using DBS.
authors.affiliation: UNC Center for AIDS Research, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. Electronic address: jnelson@med.unc.edu.
authors.forename: Julie A E
authors.initials: JA
authors.lastname: Nelson
authors.affiliation: UNC Center for AIDS Research, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
authors.forename: J Tyler
authors.initials: JT
authors.lastname: Hawkins
authors.affiliation: UNC Center for AIDS Research, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
authors.forename: Maria
authors.initials: M
authors.lastname: Schanz
authors.affiliation: UNC Center for AIDS Research, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
authors.forename: Katie
authors.initials: K
authors.lastname: Mollan
authors.affiliation: Department of Pathology and Laboratory Medicine, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
authors.forename: Melissa B
authors.initials: MB
authors.lastname: Miller
authors.affiliation: UNC Center for AIDS Research, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Pathology and Laboratory Medicine, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
authors.forename: John L
authors.initials: JL
authors.lastname: Schmitz
authors.affiliation: UNC Center for AIDS Research, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Pathology and Laboratory Medicine, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
authors.forename: Susan A
authors.initials: SA
authors.lastname: Fiscus
mesh_terms: D000328:Adult; D004279:DNA, Viral / Q000097:blood*; D059788:Dried Blood Spot Testing / Q000379:methods*; D042241:Early Diagnosis; D015658:HIV Infections / Q000097:blood* / Q000175:diagnosis*; D006679:HIV Seropositivity / Q000821:virology; D015497:HIV-1 / Q000235:genetics*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D025202:Molecular Diagnostic Techniques / Q000379:methods; D012680:Sensitivity and Specificity; D019562:Viral Load / Q000379:methods
chemical_list: D004279:DNA, Viral
keywords: Dried blood spots; Early infant diagnosis; HIV