World Academy of Science, Engineering and Technology
Published May 2, 2015 | Version 10001321
Journal article Open

Performance of the Aptima® HIV-1 Quant Dx Assay on the Panther System

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The Aptima® HIV-1 Quant Dx Assay is a fully automated assay on the Panther system. It is based on Transcription- Mediated Amplification and real time detection technologies. This assay is intended for monitoring HIV-1 viral load in plasma specimens and for the detection of HIV-1 in plasma and serum specimens. Nine-hundred and seventy nine specimens selected at random from routine testing at St Thomas' Hospital, London were anonymised and used to compare the performance of the Aptima HIV-1 Quant Dx assay and Roche COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0. Two-hundred and thirty four specimens gave quantitative HIV-1 viral load results in both assays. The quantitative results reported by the Aptima Assay were comparable to those reported by the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, v2.0 with a linear regression slope of 1.04 and an intercept on -0.097. The Aptima assay detected HIV-1 in more samples than the COBAS assay. This was not due to lack of specificity of the Aptima assay because this assay gave 99.83% specificity on testing plasma specimens from 600 HIV-1 negative individuals. To understand the reason for this higher detection rate a side-by-side comparison of low level panels made from the HIV-1 3rd international standard (NIBSC10/152) and clinical samples of various subtypes were tested in both assays. The Aptima assay was more sensitive than the COBAS assay. The good sensitivity, specificity and agreement with other commercial assays make the HIV-1 Quant Dx Assay appropriate for both viral load monitoring and detection of HIV-1 infections.

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  • Mellors, J.W., C. R. Rinaldo, Jr, P. Gupta , R. M. White, J. A. Todd , L. A. Kingsley 1996. Prognosis in HIV-1 infection predicted by the quantity of virus in plasma. Science 272:1167–1170.
  • Wei X., S. K.Ghosh, M.E. Taylor , V. A. Johnson , E. A. Emini, P. Deutsch , J. D. Lifson, S. Bonhoeffer, M. A. Nowak, B. H. Hahn. 1995. Viral dynamics in human immunodeficiency virus type 1 infection. Nature 373:117–122.
  • Perelson A.S., A. U. Neumann, M. Markowitz, J. M. Leonard, D.D. Ho 1996. HIV-1 dynamics in vivo: Virion clearance rate, infected cell lifespan, and viral generation time. Science 271:1582–1586
  • O'Brien, W. A., P. M. Hartigan, D. Martin, J. Esinhart, A. Hill, S. Benoit, M. Rubin, M. S. Simberkoff, and J. D. Hamilton. 1996. 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. 334:426-431.
  • Welles, S. L., J. B. Jackson, B. Yen-Lieberman, L. Demeter, A. J. Japour, L. M. Smeaton, V. A. Johnson, D. R. Kuritzkes, R. T. P. A. Reichelderfer, D. D. Richman, R. Reichman, M. Fischl, R. Dolin, R. W. Coombs, J. O. Kahn, C. McLaren, J. Todd, S. Kwok, and C. S. Crumpacker. 1996. Prognostic value of plasma human immunodeficiency virus type I (HIV-1) RNA levels in patients with advanced HIV-1 disease and with little or no zidovudine therapy. AIDS Clinical Trials Group Protocol 116A/116B/117 Team. J. Infect. Dis. 174:696-703.
  • Coombs, R. W., S. L. Welles, C. Hooper, P. S. Reichelderfer, R. T. D'Aquila, A. J. Japour, V. A. Johnson, D. R. Kuritzkes, D. D. Richman, S. Kwok, J. Todd, J. B. Jackson, V. DeGruttola, C. S. Crumpacker, and J. Kahn. 1996. Association of plasma human immunodeficiency virus Type I RNA level with risk of clinical progression in patients with advanced infection. AIDS Clinical Trials Group (ACTG) 116B/117 Study Team. ACTG Virology Committee Resistance and HIV-1 RNA Working Groups. J. Infect. Dis. 174:704-712.
  • Human immunodeficiency virus type 1 RNA level and CD4 count as prognostic markers and surrogate end points: a meta-analysis. HIV Surrogate Marker Collaborative Group. AIDS Res Hum Retroviruses. 2000;16 (12):1123-1133.
  • Brenner B.G., M. Roger , J.P. Routy, D. Moisi, M. Ntemgwa, C. Matte, J. G. Baril, R. Thomas, D.Rouleau, J. Bruneau, R. Leblanc, M. Legault, C. Tremblay, H. Charest, M. A. Wainberg. Quebec Primary HIV Infection Study Group. 2007 High rates of forward transmission events after acute/early HIV-1 infection. J Infect Dis;195: 951-959.
  • Cohen M.S., Y.Q. Chen, M. McCauley, T. Gamble, M. C. Hosseinipour, N. Kumarasamy, J.G. Hakim, J. Kumwenda, B. Grinsztejn, J.H.S. Pilotto, S.V. Godbole, S. Mehendale, S. Chariyalertsak, B.R. Santos, K.H. Mayer, I.F. Hoffman , S.H. Eshleman, E. Piwowar-Manning, L. Wang, J. Makhema, L.A. Mills, G. de Bruyn, I. Sanne, J. Eron, J. Gallant, D. Havlir, S. Swindells, H. Ribaudo, V. Elharrar, D. Burns, T. E. Taha, K. Nielsen-Saines, D. Celentano, M. Essex, and T.R. Fleming for the HPTN 052 Study Team Prevention of HIV-1 infection with early antiretroviral therapy. 2011 Prevention of HIV-1 Infection with Early Antiretroviral Therapy. N Engl J Med.; 365(6):493-505. [10] WHO. 2013. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. World Health Organization, Geneva, Switzerland. http://www.who.int/hiv/pub/guidelines/arv2013/en/ [11] WHO. 2014. March 2014 supplement to the 2013 consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. World Health Organization, Geneva, Switzerland. http://www.who.int/hiv/pub/ guidelines/arv2013/arvs2013upplement_march2014/en/ [12] Bennett B, S. Fordan, L. Haddock-Morilla, M. Rowlinson 2013 HIV Single staging algorithm: integration and maximization of resources by reducing time between HIV diagnosis and treatment. J. Clin.Virol 58(1):34-37. [13] Styer L.S., T.J. Sullivan, M.M. Parker 2011. Evaluation of an alternative supplemental testing strategy for HIV diagnosis by retrospective analysis of clinical HIV testing data Journal Clin. Virol 52 (1): S35– 40 [14] Amendola A., P. Marsella, M. Boisi, F. Forbici, C. Angeletti, M. R. Capobianchi. 2014. Ability of two commercially available assays (Abbott RealTime HIV-1 and Roche AmpliPrep/Cobas Taqman HIV-1 Version 2.0) to quantify low HIV-1 RNA levels (<2,000 copies/millileter); Comparison of clinical samples and NIBSC working reagents for nucleic acid testing assays. J. Clin. Microbiol. 52(6): 2019- 2026 [15] Sire J.M., M. Vray, M. Merzouk, J.C. Plantier, J. Pavie, S.Maylin, J. Timsit, C. Lascoux-Combe, J. Molina, F. Simon and C.Delaugerre. 2011 Comparative RNA quantification of HIV-1 Group M and Non M with the Roche Cobas AmpliPrep/Cobas Taqman HIV-1 v2.0 and Abbott RealTime HIV-1 PCR Assays. J. Acquir. Immune Defic. Syndr. 56(3): 239-242. [16] Karasi J.C., F. Dziezuk, L. Quennery, S. Forster, U Reischl, G. Colucci, D. Schoener, C. Seguin-Devaux, J.C Schmit. 2011. High correlation between the Roche COBAS AmpliPrep/COBAS Taqman HIV-1, v2.0 and the Abbott m2000 RealTime HIV-1 assays for quantification of viral load in HIV-1 B and non-B subtypes. J. Clin. Virol. 52: 181-186. [17] Swenson L.C., B. Cobb, A.M. Geretti, P.R. Harrigan, M. Polijak, C. Seguin-Devaux, C. Verhofstede, M. Wirden, A. Amendola, J. Boni, T. Bourlet, J.B. Huder, J.C. Karasi, S. Zidovec Lepej, M.M. Lunar, O. Mukabayire, R. Schuurman, J. Tomažič, K. Van Laethem, L. Vandekerckhove, and A. M. Wensing; International Viral Load Assay Collaboration 2014 Comparative Performances of HIV-1 RNA Load Assays at Low Viral Load Levels: Results of an International Collaboration J. Clin. Microbiol 52(2):517-523. [18] Pyne M. T., A. Wilson, D.R. Hilliyard. 2012. Large-scale comparison of Roche Cobas AmpliPrep/cobas TaqMan and Abbott RealTime HIV assays. J. Virol. Methods 184: 106-108. [19] Gatanaga H, K., Tsukada, H. Honda, J. Tanuma, H. Yazaki, T. Watanabe, M. Honda, K. Teruya, Y. Kikuchi and S. Oka 2009 Detection of HIV type 1 load by the Roche Cobas TaqMan assay in patients with viral loads previously undetectable by the Roche Cobas Amplicor Monitor. Clin Infect Dis 48:260–2. [20] Rebeiro P.F., A. Kheshti, S. S. Bebawy, S. E. Stinnette, H. Erdem , Y.Tang, T. R. Sterling, S.P. Raffanti, R. T. D'Aquila 2008. Increased Detectability of Plasma HIV-1 RNA after Introduction of a New Assay and Altered Specimen-Processing Procedures Clin Infect Dis. 47 (10): 1354-1357. [21] Rensburg E.J., K. Tait, A. Watt, R. Schall. 2011. Comparative Evaluation of Roche Cobas Ampliprep/Cobas Tqman HIV-1 version 2 Test using TaqMan 48 Analyzer and the Abbott RealTime HIV-1 Assay. J. Clin. Microbiol 49(1):377-379.