References

  1. Silvester C, Healey DS, Cunningham P, Dax EM.  Multisite evaluation of four anti-HIV-1/HIV-2 enzyme immunoassays. Australian HIV Test Evaluation Group. J Acquir Immune Defic Syndr Hum Retrovirol 1995;8:411-9.
  2. Branson BM and Stekler JD Detection of Acute HIV Infection: We Can’t Close the Window. editorial commentary JID 2012;205:521 Stekler J,  Maenza J, Stevens CE,  Swenson PD: et al, Screening for Acute HIV Infection: Lessons Learned. CID 2007; 44:459–61
  3. Conway DP,, Holt M, McNulty A, Couldwell DL, Smith DE, Davies SC,  Cunningham P, Keen P, Guy R, and on behalf of the Sydney Rapid HIV Test Study Multi-Centre: Evaluation of the Determine HIV Combo Assay when Used for Point of Care Testing in a High Risk Clinic-Based Population PLoS One. 2014; 9(4): e94062.
  4. Australian Government Department of Health. Therapeutic Goods Administration (TGA). Clinical performance requirements and risk mitigation strategies for HIV tests. Version 1.0, March 2015 [internet].  Available at: https://www.tga.gov.au/publication/clinical-performance-requirements-and-risk-mitigation-strategies-hiv-tests(last accessed 2 November 2016).
  5. Weber B, Berger A, Rabenau H, Doerr HW: Evaluation of a new combined antigen and antibody human immunodeficiency virus screening assay, VIDAS HIV DUO Ultra. J Clin Microbiol 2002;40:1420-6.
  6. Mellors JW, Kingsley LA, Rinaldo CR Jr, Todd JA, Hoo BS, Kokka RP, et al. Quantitation of HIV-1 RNA in plasma predicts outcome after seroconversion. Ann Intern Med 1995;122:573-9.
  7. O’Brien WA, Hartigan PM, Martin D, Esinhart J, Hill A, Benoit S, et al. Changes in plasma HIV-1 RNA and CD4+ lymphocyte counts and the risk of progression to AIDS. Veterans Affairs Cooperative Study Group on AIDS. N Engl J Med 1996;334:426-31.
  8. Daar ES, Little S, Pitt J, Santangelo J, Ho P, Harawa N, et al: Diagnosis  of  primary  HIV-1  infection.  Los Angeles County Primary HIV Infection Recruitment Network. Ann Intern Med 2001;134:25-9.
  9. Oliver AR, Pereira SF, Clark DA:  Comparative evaluation of the automated Roche TaqMan real-time quantitative human immunodeficiency virus type 1 RNA PCR assay and the Roche AMPLICOR Version 1.5 conventional PCR assay. J. Clin. Microbiol 2007;45: 3616-9.
  10. Roche Molecular Systems, COBAS AmpliPrep/COBAS TAQMAN HIV-1 Test, package insert. P/N: 03543005. 2004.
  11. Hecht FM, Busch MP, Rawal B, Webb M, Rosenberg E, Swanson M, et al: Use of laboratory tests and clinical symptoms for identification of primary HIV infection. AIDS 2002;16:1119-29.
  12. Swanson P, Soriano V, Devare SG, Hackett J, Jr: Comparative performance of three viral load assays on human immunodeficiency virus type 1 (HIV-1) isolates representing group M (subtypes A to G) and group O: LCx HIV RNA quantitative, AMPLICOR HIV-1 MONITOR version 1.5, and Quantiplex HIV-1 RNA version 3.0. J Clin Microbiol 2001;39:862-70.
  13. Clarke JR, Galpin S, Braganza R, Ashraf A, Russell R, Churchill DR, et  al:  Comparative quantification of diverse serotypes of HIV- 1 in plasma from a diverse population of patients. J Med Virol 2000;62:445-9.
  14. Roche Molecular Systems, COBAS AmpliPrep/COBAS TAQMAN HIV-1 Test, package insert. P/N: 03543005. 2004.
  15. Swanson P, Huang S,  Holzmayer V, Bodelle P, Yamaguchi J, Brennan C, et al: Performance of the automated Abbott RealTimeTM HIV-1 assay on a genetically diverse panel of specimens from Brazil. J Virol Methods 2006;134:237-43.
  16. Tang N, Huang S, Salituro J, Mak WB, Cloherty G, Johanson J, et al. A Real Time HIV-1 viral load assay for automated quantitation of HIV-1 RNA in genetically diverse group M subtypes A-H, group O and group N samples. J Virol Methods 2007;146:236-45.
  17. Deacon NJ, Tsykin A,  Solomon  A,  Smith  K,  Ludford-Menting M, Hooker DJ, et al. Genomic structure of an attenuated quasi species of HIV-1 from a blood transfusion donor and recipients. Science 1995;270:988-91.
  18. Oelrichs RB, Lawson VA, Coates KM, Chatfield C, Deacon NJ, McPhee DA: Rapid full-length genomic sequencing of two cytopathically heterogeneous Australian primary HIV-1 isolates. J Biomed Sci 2000;7:128-35.
  19. Prado JG, Shintani A, Bofill M, Clotet B, Ruiz L, Martinez-Picado J. Lack  of  longitudinal  intrapatient correlation  between  p24 antigenemia and levels of HIV-1 RNA in patients with chronic HIV infection during structured treatment interruptions.  J Clin Microbiol 2004;42:1620-5.
  20. Bonard D, Rouet F, Toni TA, Minga A, Huet C, Ekouévi DK, et al. Field evaluation of an improved assay using a heat-dissociated p24 antigen for adults mainly infected with HIV-1 CRF02_AG strains  in  Cote  d’Ivoire, West  Africa.  J  Acquir Immune Defic Syndr 2003;34:267-73.
  21. Bonard D, Rouet F, Toni TA, Minga A, Huet C, Ekouévi DK, et al. Field evaluation of an improved assay using a heat-dissociated p24 antigen for adults mainly infected with HIV-1 CRF02_AG strains  in  Cote  d’Ivoire, West  Africa.  J  Acquir Immune Defic Syndr 2003;34:267-73.
  22. Fiscus SA, Wiener J, Abrams EJ,  Bulterys  M,  Cachafeiro  A, Respess RA. Ultrasensitive p24 assay for diagnosis of perinatal Human Immunodeficiency Virus type 1 infection.  J  Clin Microbiol 2007; 45:2274-7
  23. Preston BD, Poiesz BJ, Loeb LA. Fidelity of HIV-1 reverse transcriptase. Science 1988;242:1168-71. Roberts JD, Bebenek K, Kunkel TA.  The accuracy of reverse transcriptase from HIV-1. Science 1988;242:1171-3.
  24. Cohen CJ, Hunt S, Sension M, Farthing C, Conant M, Jacobson S, et al. A randomized trial assessing the impact of phenotypic resistance testing on antiretroviral therapy. AIDS 2002;16:579-88.
  25. Meynard JL, Vray M, Morand-Joubert L, Race E, Descamps D, Peytavin G, et al. Phenotypic or genotypic resistance testing for choosing antiretroviral therapy after treatment failure: a randomized trial. AIDS 2002;16:727-36.
  26. Tural C, Ruiz L, Holtzer C, Schapiro J, Viciana P, González J, et al. Clinical utility of HIV-1 genotyping and expert advice: the Havana trial. AIDS 2002;16:209-18.
  27. Haubrich RH, Kemper CA, Hellmann NS, Keiser PH, Witt MD, Tilles JG, et al. A randomized, prospective study of phenotype susceptibility testing versus standard of care to manage antiretroviral therapy: CCTG 575. AIDS 2005;19:295-302.
  28. Ena J, Ruiz de Apodaca RF, Amador C. Net benefits of resistance testing directed therapy compared with standard of care in HIV-infected patients with virological failure: A meta-analysis. Enferm Infecc Microbiol Clin 2006;24:232-7.
  29. Haupts S, Ledergerber B, Böni J, Schüpbach J, Kronenberg A, Opravil M, et al. Impact of genotypic resistance testing on selection of salvage regimen in clinical practice. Antivir Ther 2003;8:443-54.
  30. Simcock M, Sendi P, Ledergerber B, Keller T, Schüpbach J, Battegay M, et al. A longitudinal analysis of healthcare costs after treatment optimization following genotypic antiretroviral resistance testing: does resistance testing pay off?. Antivir Ther 2006;11:305-14.
  31. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. Available http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf.
  32. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Laboratory Testing, Drug-Resistance Testing (http://aidsinfo.nih.gov/guidelines).
  33. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Laboratory Testing, Drug-Resistance Testing (http://aidsinfo.nih.gov/guidelines)
  34. Whitcomb JM, Huang W, Fransen S, Limoli K, Toma J, Wrin T, et  al. Development and Characterization of a Novel Single- Cycle    Recombinant-Virus Assay to Determine  Human Immunodeficiency Virus Type 1 Coreceptor Tropism. Antimicrobial Agents and Chemotherapy 2007;51:566-75
  35. Braun P, Wiesmann F. Phenotypic assays for the determination of coreceptor tropism in HIV-1 infected individuals. Eur J Med Res 2007;12:463-72.
  36. Hughes CA, Foisy MM, Dewhurst N et al. Abacavir hypersensitivity reaction: an update. Ann Pharmacother. 2008;42:387-96.
  37. Martin AM, Nolan D, Gaudieri S, et al. Predisposition to abacavir hypersensitivity conferred by HLA-B*5701 and a haplotypic Hsp70-Hom variant. Proc Natl Acad Sci U S A 2004;101:4180-5.
  38. Hologic, Inc. November 2014. Aptima HIV-1 Quant Dx assay product information. Hologic, Inc, San Diego, CA. http://stage.hologic.com/products/clinical-diagnostics-and-bloodscreening/assays-and-tests/Aptima-hiv-1-quant-dx-assay.
  39. EUROArray HLA-B57:01 Direct Test instruction for the molecular genetic test. MN_5210-V_A_UK_C04.doc. Version: 22/11/2016