Performance of the Aptima® HIV-1 Quant Dx Assay on the Panther System
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.
[1] 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.
[2] 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.
[3] 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
[4] 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.
[5] 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.
[6] 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.
[7] 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.
[8] 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.
[9] 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.
[1] 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.
[2] 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.
[3] 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
[4] 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.
[5] 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.
[6] 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.
[7] 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.
[8] 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.
[9] 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.
@article{"International Journal of Medical, Medicine and Health Sciences:69840", author = "Siobhan O’Shea and Sangeetha Vijaysri Nair and Hee Cheol Kim and Charles Thomas Nugent and Cheuk Yan William Tong and Sam Douthwaite and Andrew Worlock", title = "Performance of the Aptima® HIV-1 Quant Dx Assay on the Panther System", abstract = "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.", keywords = "HIV viral load, Aptima, Roche, Panther system.", volume = "9", number = "5", pages = "397-4", }
