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

Clinical Chemistry and Laboratory Medicine

Volumn 54, Issue 3, 2016, Pages 493-499

  Schalasta, Gunnar ^a   Börner, Anna ^a   Speicher, Andrea ^a   Enders, Martin ^a  

^a Labor Prof Gisela Enders MVZ   (Germany)

Author keywords

Aptima; COBAS; HIV; quantification; TMA; viral load

Indexed keywords

VIRUS RNA;

ARTICLE; BLOOD SAMPLING; CONTROLLED STUDY; HIV RAPID TEST; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS ASSAY; HUMAN PAPILLOMAVIRUS DNA TEST; INTERMETHOD COMPARISON; LIMIT OF QUANTITATION; MAJOR CLINICAL STUDY; PRIORITY JOURNAL; REFERENCE VALUE; SERODIAGNOSIS; VIRUS DETECTION; VIRUS LOAD; BIOASSAY; BLOOD; COMPARATIVE STUDY; DEVICES; GENETICS; PROCEDURES; STANDARDS; STATISTICAL MODEL;

BIOLOGICAL ASSAY; HIV-1; HUMANS; LINEAR MODELS; RNA, VIRAL;

EID: 84958817310     PISSN: 14346621     EISSN: 14374331     Source Type: Journal    
DOI: 10.1515/cclm-2015-0522     Document Type: Article

References (22)

1. Hughes MD, Johnson VA, Hirsch MS, Bremer JW, Elbeik T, Erice A, et al. Monitoring plasma HIV-1 RNA levels in addition to CD4+ lymphocyte count improves assessment of antiretroviral therapeutic response. Ann Intern Med 1997;126:929-38.
2. Mellors JW, Muñoz A, Giorgi JV, Margolick JB, Tassoni CJ, Gupta P, et al. Plasma viral load and CD4+ lymphocytes as prognostic markers of HIV-1 infection. Ann Intern Med 1997;126:946-54.
3. O'Brien WA, Hartigan PM, Daar ES, Simberkoff MS, Hamilton JD. Changes in plasma HIV RNA levels and CD4+ lymphocyte counts predict both response to antiretroviral therapy and therapeutic failure. VA Cooperative Study Group on AIDS. Ann Intern Med 1997;126:939-45.
4. Asboe D, Aitken C, Boffito M, Booth C, Cane P, Fakoya A, et al., on behalf of the BHIVA Guidelines Subcommittee. British HIV Association guidelines for the routine investigation and monitoring of adult HIV-1-infected individuals 2011. HIV Med 2012;13:1-44.
5. Website: Department of Health and Human Services. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Available from: http://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Accessed 1 December, 2014.
6. Thompson MA, Aberg JA, Hoy JF, Telenti A, Benson C, Cahn P, et al. Antiretroviral treatment of adult HIV infection: 2012 recommendations of the International Antiviral Society-USA panel. J Am Med Assoc 2012;308:387-402.
7. World Health Organization. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. Recommendations for a public health approach. Geneva, Switzerland: WHO Press, 2013.
8. Bourlet T, Signori-Schmuck A, Roche L, Icard V, Saoudin H, Trabaud MA, et al. HIV-1 load comparison using four commercial real-time assays. J Clin Microbiol 2011;49:292-7.
9. Church D, Gregson D, Lloyd T, Klein M, Beckthold B, Laupland K, et al. Comparison of the RealTime HIV-1, COBAS TaqMan 48 v1.0, Easy Q v1.2 and Versant assays for determination of HIV-1 viral loads in a cohort of Canadian patients with diverse HIV subtype infections. J Clin Microbiol 2011;49:118-24.
10. Garcia-Diaz A, Clewley GS, Booth CL, Labett W, McAllister N, Geretti AM. Comparative evaluation of the performance of the Abbott Real-Time Human Immunodeficiency Virus type 1 (HIV-1) assay for the measurement of HIV-1 plasma viral load following automated specimen preparation. J Clin Microbiol 2006;44:1788-91.
11. Garcia-Diaz A, Labbett W, Clewley GS, Guerrero-Ramos A, Geretti AM. Comparative evaluation of the Artus HIV-1 QS-RGQ assay and the Abbott RealTime HIV-1 assay for the quantification of HIV-1 RNA in plasma. J Clin Virol 2013;57:66-9.
12. Schutten M, Peters D, Back NK, Beld M, Beuselinck K, Foulongne V, et al. Multicenter evaluation of the new Abbott RealTime assays for quantitative detection of human immunodeficiency virus type 1 and hepatitis C virus RNA. J Clin Microbiol 2007;45:1712-7.
13. Perrin L, Pawlotsky JM, Bouvier-Alias M, Sarrazin C, Zeuzem S, Colucci G. Multicenter performance evaluation of a new TaqMan PCR assay for monitoring human immunodeficiency virus RNA load. J Clin Microbiol 2006;44:4371-5.
14. Coombs R, Bremer J, Sanchez J, La Rosa A, Fernandes H, Ganoza C, et al. Clinical performance evaluation of the COBAS TaqMan HIV-1 Test for use with the High Pure System v2.0 (HPS/CTM HIV v2) using manual specimen extraction, compared to the COBAS AmpliPrep/COBAS TaqMan HIV-1 Test v2.0 (CAP/CTM HIV Test v2) using automated specimen extraction. J Int AIDS Soc 2012;15(Suppl 3):THPE060.
15. Ferenci P, Fried MW, Shiffman ML, Smith CI, Marinos G, Goncales FL Jr, et al. Predicting sustained virological responses in chronic hepatitis C patients treated with peginterferon alfa-2a (40 KD)/ribavirin. J Hepatol 2005;43:425-33.
16. Wiesmann F, Naeth G, Sarrazin C, Berger A, Kaiser R, Ehret R, et al. Variation analysis of six HCV viral load assays using low viremic HCV samples in the range of the clinical decision points for HCV protease inhibitors. Med Microbiol Immunol 2015;204:515-25.
17. Pyne MT, Vest L, Clement J, Lee J, Rosvall JR, Luk K, et al. Comparison of three Roche hepatitis B virus viral load assay formats. J Clin Microbiol 2012;50:2337-42.
18. Hill CS. Molecular diagnostic testing for infectious diseases using TMA technology. Expert Rev Mol Diagn 2001;1:445-55.
19. Janssens W, Heyndrickx L, Fransen K, Motte J, Peeters M, Nkengasong JN, et al. Genetic and phylogenetic analysis of env subtypes G and H in central Africa. Aids Res Hum Retroviruses 1994;10:877-9.
20. Paba P, Fabeni L, Ciccozzi M, Perno CF, Ciotti M. Performance evaluation of the COBAS/TaqMan HIV-1 v2.0 in HIV-1 positive patients with low viral load: a comparative study. J Virol Methods 2011;173:399-402.
21. Ruelle J, Debaisieux L, Vancutsem E, De Bel A, Delforge ML, Piérard D, et al. HIV-1 low-level viraemia assessed with 3 commercial real-time PCR assays show high variability. BMC Infect Dis 2012;12:100-5.
22. Yan CS, Hanafi I, Kelleher AD, Carr AD, Amin J, McNally LP, et al. Lack of correlation between three commercial platforms for the evaluation of human immunodeficiency virus type 1 (HIV-1) viral load at the clinically critical lower limit of quantification. J Clin Virol 2010;49:249-53.