Evaluation of Hologic Aptima HIV-1 Quant Dx assay on the Panther system on HIV subtypes

Journal of Clinical Microbiology

Volumn 54, Issue 10, 2016, Pages 2575-2581

  Manak, Mark M ^a   Hack, Holly R ^a   Nair, Sangeetha V ^b   Worlock, Andrew ^b   Malia, Jennifer A ^c   Peel, Sheila A ^c   Jagodzinski, Linda L ^c  

^a HENRY M JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE   (United States)

^b HOLOGIC INC   (United States)

^c WALTER REED ARMY INSTITUTE OF RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GAG PROTEIN; VIRUS RNA;

ARTICLE; CONTROLLED STUDY; ENVELOPE GENE; ENZYME IMMUNOASSAY; GAG GENE; GENE SEQUENCE; HIV RAPID TEST; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 SUBTYPE A; HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 SUBTYPE B; HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 SUBTYPE C; HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 SUBTYPE CRF01 AE; HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 SUBTYPE CRF02 AG; HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 SUBTYPE D; LIMIT OF DETECTION; LONG TERMINAL REPEAT; NONHUMAN; PRIORITY JOURNAL; STRUCTURAL GENE; VIRUS LOAD; VIRUS REPLICATION; CLASSIFICATION; GENETICS; GENOTYPE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; ISOLATION AND PURIFICATION; MOLECULAR DIAGNOSIS; PROCEDURES; VIROLOGY;

GENOTYPE; HIV; HIV INFECTIONS; HUMANS; MOLECULAR DIAGNOSTIC TECHNIQUES; VIRAL LOAD;

EID: 84991255897     PISSN: 00951137     EISSN: 1098660X     Source Type: Journal    
DOI: 10.1128/JCM.01350-16     Document Type: Article

References (37)

1. World Health Organization (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/. Accessed 20 February 2016.
2. Department of Health and Human Services (DHHS) Panel on Antiretroviral Guidelines for Adults and Adolescents. 28 January 2016. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Accessed 16 February 2016.
3. Williams I, Churchill D, Anderson J, Boffito M, Bower M, Cairns G, Cwynarski K, Edwards S, Fidler S, Fisher M, Freedman A, Geretti AM, Gilleece Y, Horne R, Johnson M, Khoo S, Leen C, Marshall N, Nelson M, Orkin C, Paton N, Phillips A, Post F, Pozniak A, Sabin C, Trevelion R, Ustianowski A, Walsh J, Waters L, Wilkins E, Winston A, Youle M. 2014. British HIV Association guidelines for the treatment of HIV-1-positive adults with antiretroviral therapy 2012. (Updated November 2013. All changed text is cast in yellow highlight.) HIV Med 15(Suppl 1):S1-S85. http://dx.doi.org/10.1111/hiv.12119.
4. European AIDS Clinical Society. October 2015. EACS guidelines, version 8.0. http://www.eacsociety.org/guidelines/eacs-guidelines/eacsguidelines.html. Accessed 26 February 2016.
5. Eron JJ, Cooper DA, Steigbigel RT, Clotet B, Gatell JM, Kumar PN, Rockstroh JK, Schechter M, Markowitz M, Yeni P, Loutfy MR, Lazzarin A, Lennox JL, Strohmaier KM, Wan H, Barnard RJ, Nguyen BY, Teppler H, BENCHMRK Study Teams. 2013. Efficacy and safety of raltegravir for treatment of HIV for 5 years in the BENCHMRK studies: final results of two randomised, placebo-controlled trials. Lancet Infect Dis 13:587-596. http://dx.doi.org/10.1016/S1473-3099(13)70093-8.
6. Laprise C, de Pokomandy A, Baril JG, Dufresne S, Trottier H. 2013. Virologic failure following persistent low-level viremia in a cohort of HIV-positive patients: results from 12 years of observation. Clin Infect Dis 57:1489-1496. http://dx.doi.org/10.1093/cid/cit529.
7. Taiwo B, Gallien S, Aga E, Ribaudo H, Haubrich R, Kuritzkes DR, Eron JJ, Jr. 2011. Antiretroviral drug resistance in HIV-1-infected patients experiencing persistent low-level viremia during first-line therapy. J Infect Dis 204:515-520. http://dx.doi.org/10.1093/infdis/jir353.
8. Bennett B, Hardy B, Fordan S, Haddock-Morilla L, Rowlinson MC, Crowe S. 2013. HIV single staging algorithm: integration and maximization of resources by reducing time between HIV diagnosis and treatment. J Clin Virol 58(Suppl 1):e34-e37. http://dx.doi.org/10.1016/j.jcv.2013.07.020.
9. Korber B, Gaschen B, Yusim K, Thakallapally R, Kesmir C, Detours V. 2001. Evolutionary and immunological implications of contemporary HIV-1 variation. Br Med Bull 58:19-42. http://dx.doi.org/10.1093/bmb/58.1.19.
10. Plantier JC, Djemai M, Lemée V, Reggiani A, Leoz M, Burc L, Vessière A, Rousset D, Poveda JD, Henquell C, Gautheret-Dejean A, Barin F. 2009. Census and analysis of persistent false-negative results in serological diagnosis of human immunodeficiency virus type 1 group O infections. J Clin Microbiol 47:2906-2911. http://dx.doi.org/10.1128/JCM.00602-09.
11. Kim JE, Beckthold B, Chen Z, Mihowich J, Malloch L, Gill MJ. 2007. Short communication: identification of a novel HIV type 1 subtype H/J recombinant in Canada with discordant HIV viral load (RNA) values in three different commercial assays. AIDS Res Hum Retroviruses 23:1309-1313. http://dx.doi.org/10.1089/aid.2007.0080.
12. Geretti AM, Harrison L, Green H, Sabin C, Hill T, Fearnhill E, Pillay D, Dunn D, UK Collaborative Group on HIV Drug Resistance. 2009. Effect of HIV-1 subtype on virologic and immunologic response to starting highly active antiretroviral therapy. Clin Infect Dis 48:1296-1305. http://dx.doi.org/10.1086/598502.
13. Martinez-Cajas JL, Pai NP, Klein MB, Wainberg MA. 2009. Differences in resistance mutations among HIV-1 non-subtype B infections: a systematic review of evidence (1996-2008). J Int AIDS Soc 12:11. http://dx.doi.org/10.1186/1758-2652-12-11.
14. Kiwanuka N, Laeyendecker O, Robb M, Kigozi G, Arroyo M, McCutchan F, Eller LA, Eller M, Makumbi F, Birx D, Wabwire-Mangen F, Serwadda D, Sewankambo NK, Quinn TC, Wawer M, Gray R. 2008. Effect of human immunodeficiency virus type 1 (HIV-1) subtype on disease progression in persons from Rakai, Uganda, with incident HIV-1 infection. J Infect Dis 197:707-713. http://dx.doi.org/10.1086/527416.
15. Baeten JM, Chohan B, Lavreys L, Chohan V, McClelland RS, Certain L, Mandaliya K, Jaoko W, Overbaugh J. 2007. HIV-1 subtype D infection is associated with faster disease progression than subtype A in spite of similar plasma HIV-1 loads. J Infect Dis 195:1177-1180. http://dx.doi.org/10.1086/512682.
16. Vasan A, Renjifo B, Hertzmark E, Chaplin B, Msamanga G, Essex M, Fawzi W, Hunter D. 2006. Different rates of disease progression of HIV type 1 infection in Tanzania based on infecting subtype. Clin Infect Dis 42:843-852. http://dx.doi.org/10.1086/499952.
17. Kiwanuka N, Laeyendecker O, Quinn TC, Wawer MJ, Shepherd J, Robb M, Kigozi G, Kagaayi J, Serwadda D, Makumbi FE, Reynolds SJ, Gray RH. 2009. HIV-1 subtypes and differences in heterosexual HIV transmission among HIV-discordant couples in Rakai, Uganda. AIDS 23:2479-2484. http://dx.doi.org/10.1097/QAD.0b013e328330cc08.
18. Renjifo B, Gilbert P, Chaplin B, Msamanga G, Mwakagile D, Fawzi W, Essex M, Tanzanian Vitamin and HIV Study Group. 2004. Preferential in-utero transmission of HIV-1 subtype C as compared to HIV-1 subtype A or D. AIDS 18:1629-1636. http://dx.doi.org/10.1097/01.aids.0000131392.68597.34.
19. Hemelaar J, Gouws E, Ghys PD, Osmanov S, WHO-UNAIDS Network for HIV Isolation and Characterisation. 2011. Global trends in molecular epidemiology of HIV-1 during 2000-2007. AIDS 25:679-689. http://dx.doi.org/10.1097/QAD.0b013e328342ff93.
20. 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.
21. Brown B, Darden J, Tovanabutra S, Oblander T, Frost J, Sanders-Buell E, de Souza M, Birx D, McCutchan F, Polonis V. 2005. Biologic and genetic characterization of a panel of 60 human immunodeficiency virus type 1 isolates, representing clades A, B, C, D, CRF01-AE, and CRF02-AG, for the development and assessment of candidate vaccines. J Virol 79:6089-6101. http://dx.doi.org/10.1128/JVI.79.10.6089-6101.2005.
22. Huang D, Giesler T, Bremer J. 2003. Sequence characterization of the protease and partial reverse transcriptase proteins of the NED panel, an international HIV type 1 subtype reference and standards panel. AIDS Res Hum Retroviruses 19:321-328. http://dx.doi.org/10.1089/088922203764969528.
23. Manak M, Sina S, Anekella B, Sanders-Buell E, Garrett P, Ragupathy V, Hewlett I, Kim J, Vermeulen M, Stramer S, Sabino E, Michael N, Peel S, Tovanabutra S, Busch M, Schito M. 2012. Pilot studies for development of an HIV subtype panel for surveillance of global diversity. AIDS Res Hum Retroviruses 28:594-606. http://dx.doi.org/10.1089/aid.2011.0271.
24. Sanchez AM, DeMarco CT, Hora B, Keinonen S, Chen Y, Brinkley C, Stone M, Tobler L, Keating S, Schito M, Busch MP, Gao F, Denny TN. 2014. Development of a contemporary globally diverse HIV viral panel by the EQAPOL program. J Immunol Methods 409:117-130. http://dx.doi.org/10.1016/j.jim.2014.01.004.
25. Kijak GH, Tovanabutra S, Rerks-Ngarm S, Nitayaphan S, Eamsila C, Kunasol P, Khamboonruang C, Thongcharoen P, Namwat C, Premsri N, Benenson M, Morgan P, Bose M, Sanders-Buell E, Paris R, Robb M, Birx D, De Souza M, McCutchan F, Michael N, Kim J. 2013. Molecular evolution of the HIV-1 Thai epidemic between the time of RV144 immunogen selection to the execution of the vaccine efficacy trial. J Virol 87:7265-7281. http://dx.doi.org/10.1128/JVI.03070-12.
26. Roche. 2015. COBAS AmpliPrep/COBAS TaqMan HIV-1 test, version 2.0, product insert 05212308 190. Roche Diagnostics, Indianapolis, IN.
27. Abbott. 2012. RealTime HIV-1 product insert 6L18 51-602146/R7. Abbott Molecular, Des Plaines, IL.
28. Clinical and Laboratory Standards Institute (CLSI). 2012. Evaluation of detection capability for clinical laboratory measurement procedures; approved guideline - 2nd ed. CLSI document EP17-A2. Clinical and Laboratory Standards Institute, Wayne, PA.
29. Luft LM, Gill MJ, Church DL. 2011. HIV-1 viral diversity and its implications for viral load testing: review of current platforms. Int J Infect Dis 15:e661-e670. http://dx.doi.org/10.1016/j.ijid.2011.05.013.
30. Amendola A, Pisciotta M, Aleo L, Ferraioli V, Angeletti C, Capobianchi MR. 2016. Evaluation of the Aptima® HIV-1 Quant Dx assay for HIV-1 RNA viral load detection and quantitation in plasma of HIV-1 infected individuals: a comparison with Abbott RealTime HIV-1 assay. J Med Virol 88:1535-1544. http://dx.doi.org/10.1002/jmv.24493.
31. Schalasta G, Börner A, Speicher A, Enders M. 2016. Comparative evaluation of the Aptima HIV-1 Quant Dx assay and COBAS TaqMan HIV-1 v2.0 assay using the Roche High Pure system for the quantification of HIV-1 RNA in plasma. Clin Chem Lab Med 54:493-499. http://dx.doi.org/10.1515/cclm-2015-0522.
32. Hopkins M, Hau S, Tiernan C, Papadimitropoulos A, Chawla A, Beloukas A, Geretti AM. 2015. Comparative performance of the new Aptima HIV-1 Quant Dx assay with three commercial PCR-based HIV-1 RNA quantitation assays. J Clin Virol 69:56-62. http://dx.doi.org/10.1016/j.jcv.2015.05.020.
33. Sam SS, Kurpewski JR, Cu-Uvin S, Caliendo AM. 2016. Evaluation of performance characteristics of the Aptima HIV-1 Quant Dx assay for the detection and quantitation of human immunodeficiency virus type 1 in plasma and cervicovaginal lavage samples. J Clin Microbiol 54:1036-1041. http://dx.doi.org/10.1128/JCM.03289-15.
34. Nair SV, Kim HC, Fortunko J, Foote T, Peling T, Tran C, Nugent CT, Joo S, Kang Y, Wilkins B, Lednovich K, Worlock A. 2016. Aptima HIV-1 Quant Dx-A fully automated assay for both diagnosis and quantification of HIV-1. J Clin Virol 77:46-54. http://dx.doi.org/10.1016/j.jcv.2016.02.002.
35. Mor O, Gozlan Y, Wax M, Mileguir F, Rokovsky A, Noy B, Mendelson E, Levy I. 2015. Evaluation of the RealTime HIV-1, Xpert HIV-1, and Aptima HIV-1 Quant Dx assays in comparison to the NucliSens EasyQ HIV-1 v2.0 assay for quantification of HIV-1 viral load. J Clin Microbiol 53:3458-3465. http://dx.doi.org/10.1128/JCM.01806-15.
36. Ndiaye O, Diop-Ndiaye H, Ouedraogo AS, Fall-Malick FZ, Sow-Sall A, Thiam M, Diouara AA, Ndour CT, Gaye-Diallo A, Mboup S, Toure-Kane C, Study Group. 2015. Comparison of four commercial viral load techniques in an area of non-B HIV-1 subtypes circulation. J Virol Methods 222:122-131. http://dx.doi.org/10.1016/j.jviromet.2015.06.002.
37. Cunningham P, Carrera A, McNally L, Catlett B, Sherring J. 2015. Performance of the Aptima HIV-1 Quant Dx assay for quantitation of HIV-1 RNA in patients' plasma samples and in dried blood spots, poster 15-05. Abstr World STI HIV Congr, Brisbane, Australia.