Multicenter evaluation of the performance characteristics of the nucliSens HIV-1 QT assay used for quantitation of human immunodeficiency virus type 1 RNA

Journal of Clinical Microbiology

Volumn 41, Issue 1, 2003, Pages 164-173

  Ginocchio, Christine C ^a   Kemper, Marti ^a   Stellrecht, Kathleen A ^a   Witt, Donald J ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

EDETIC ACID; NUCLEIC ACID; VIRUS RNA;

ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEVICE; EVALUATION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN TISSUE; INTERMETHOD COMPARISON; MULTICENTER STUDY; NONHUMAN; NUCLEIC ACID HYBRIDIZATION; NUCLEOTIDE SEQUENCE; PRIORITY JOURNAL; QUANTITATIVE ASSAY; RANDOMIZED CONTROLLED TRIAL; REPRODUCIBILITY; SENSITIVITY AND SPECIFICITY; STANDARD; VIRUS DETECTION;

HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS 1; RNA VIRUSES;

EID: 0037234786     PISSN: 00951137     EISSN: None     Source Type: Journal    
DOI: 10.1128/JCM.41.1.164-173.2003     Document Type: Article

References (26)

1. Alaeus, A., K. Lidman, A. Sonnerborg, and J. Albert. 1997. Subtype-specific problems with quantification of plasma HIV-1 RNA. AIDS 11:859-865.
2. Boom, R., C. J. Sol, M. M. Salisman, C. J. Lansen, P. M. E. Bertheim-van Dillen, and J. van der Noordaa. 1990. Rapid and simple method for purification of nucleic acids. J. Clin. Microbiol. 28:495-503.
3. Brambilla, D., P. S. Reichelderfer, J. W. Bremer, D. E. Shapiro, R. C. Hershow, D. A. Katzenstein, S. M. Hammer, B. Jackson, A. C. Collier, R. S. Sperling, M. G. Fowler, R. W. Coombs, et al. 1999. The contribution of assay variation and biological variation to the total variability of plasma HIV-1 RNA measurements. AIDS 13:2269-2279.
4. Brown, A. E., B. Jackson, S. A. Fuller, J. Sheffield, M. A. Cannon, and J. R. Lane. 1997. Viral RNA in the resolution of human immunodeficiency virus type 1 diagnostic serology. Transfusion 37:926-929.
5. Carpenter, C. C., D. A. Cooper, M. A. Fischl, J. M. Gatell, B. G. Gazzard, S. M. Hammer, M. S. Hirsch, D. M. Jacobsen, D. A. Katzenstein, J. S. Montaner, D. D. Richman, M. S. Saag, M. Schechter, R. T. Schooley, M. A. Thompson, S. Vella, P. G. Yeni, and P. A. Volberding. 2000. Antiretroviral therapy in adults. Updated recommendations of the International AIDS Society-USA Panel. JAMA 283:381-390.
6. Chew, C. B., B. L. Herring, F. Zheng, C. Browne, N. K. Saksena, A. L. Cunningham, and D. E. Dwyer. 1999. Comparison of three commercial assays for the quantification of HIV-1 RNA in plasma from individuals infected with different HIV-1 subtypes. J. Clin. Virol. 14:87-94.
7. Cunningham, C. K., T. T. Charbonneau, K. Song, D. Patterson, T. Sullivan, T. Cummins, and B. Poiesz. 1999. Comparison of human immunodeficiency virus 1 DNA polymerase chain reaction and qualitative and quantitative RNA polymerase chain reaction in human immunodeficiency virus 1-exposed infants. Pediatr. Infect. Dis. 18:30-35.
8. Delamare, C., M. Burgard, M. J. Mayaux, S. Blanche, A. Doussin, S. Ivanoff, M. L. Chaix, C. Khan, C. Rouzioux, et al. 1997. HIV-1 RNA detection in plasma for the diagnosis of infection in neonates. J. Acquir. Immune Defic. Syndr. Hum. Retrovirol. 15:121-125.
9. Erice, A., D. Brambilla, J. Bremer, J. Brooks Jackson, R. Kokka, B. Yen-Lieberman, and R. W. Coombs. 2000. Performance characteristics of the QUANTIPLEX HIV-1 RNA 3.0 assay for detection and quantitation of human immunodeficiency virus type 1 RNA in plasma. J. Clin. Microbiol. 38:2837-2845.
10. Ginocchio, C. C. 2001. HIV-1 viral load testing. Lab. Med. 32:142-152.
11. Ho, D. D., A. U. Neuman, A. S. Perelson, W. Chen, J. Leonard, and M. Markowitz. 1995. Rapid turnover of plasma virions and CD4 lymphocytes in HIV-1 infection. Nature 373:123-126.
12. Holguin, A., C. de Mendoza, and V. Soriano. 1999. Comparison of three different commercial methods for measuring plasma viremia in patients infected with non-B HIV-1 subtypes. Eur. J. Clin. Microbiol. Infect. Dis. 18:256-259.
13. Kievits, T., B. van Gemen, D. van Strijp, R. Schukkink, M. Dircks, H. Adriaanse, L. Malek, R. Sooknanan, and P. Lens. 1991. NASBA isothermal enzymatic in vitro nucleic acid amplification optimized for the diagnosis of HIV-1 infection. J. Virol. Methods 35:273-286.
14. Marschner, I. C., A. C. Collier, R. W. Coombs, R. T. D'Aquila, V. DeGruttola, M. A. Fischl, S. M. Hammer, M. D. Hughes, V. A. Johnson, D. A. Katzenstein, D. D. Richman, L. M. Smeaton, S. A. Spector, and M. S. Saag. 1998. Use of changes in plasma levels of human immunodeficiency virus type 1 RNA to assess the clinical benefit of antiretroviral therapy. J. Infect. Dis. 177:40-47.
15. Mellors, J. W., A. M. Munoz, J. V. Giorgi, J. B. Margolick, C. J. Tassoni, P. Gupta, L. A. Kingsley, J. A. Todd, A. J. Saah, R. Detels, J. P. Phair, and C. Rinaldo, Jr. 1997. Plasma viral load and CD4+ lymphocytes as prognostic markers of HIV-1 infection. Ann. Intern. Med. 126:946-954.
16. Pantaleo, G., and J. Schupbach. 2000. Performance of five different assays for the quantification of viral load in persons infected with various subtypes of HIV-1 Swiss HIV Cohort Study. J. Acquir. Immune Defic. Syndr. 23:138-144.
17. Parekh, B., S. Phillips, T. C. Granade, J. Baggs, D. J. Hu, and R. Respess. 1999. Impact of HIV type 1 subtype variation on viral RNA quantitation. AIDS Res. Hum. Retrovir. 20:133-142.
18. Perelson, A. S., A. U. Neumann, M. Markowitz, J. M. Leonard, and D. D. Ho. 1996. HIV-1 dynamics in vivo: virion clearance rate, infected cell life span, and viral generation time. Science 271:1582-1586.
19. Rich, J. D., N. A. Merriman, E. Mylonakis, T. C. Greenough, T. Flanifan, B. J. Mady, and C. C. J. Carpenter. 1999. Misdiagnosis of HIV infection by HIV-1 plasma viral load testing: a case series. Ann. Intern. Med. 130:37-39.
20. Saag, M. S., M. Holodniy, D. R. Kuritzkes, W. A. O'Brien, R. Coombs, M. E. Poscher, D. M. Jacobsen, G. M. Shaw, D. D. Richman, and P. A. Volberding. 1996. HIV viral load markers in clinical practice. Nat. Med. 348:625-629.
21. Shearer, W. T., T. C. Quinn, P. LaRussa, J. F. Lew, L. Mofenson, S. Almy, K. Rich, E. Handelsman, C. Diaz, M. Pagano, V. Smeriglio, L. A. Kalish, and the Women and Infants Transmission Study Group. 1997. Viral load and disease progression in infants infected with human immunodeficiency virus type 1. N. Engl. J. Med. 336:1337-1342.
22. Triques, K., J. Coste, J. L. Perret, C. Segarra, E. Mpoudi, J. Reynes, E. Delaporte, A. Butcher, K. Dreyer, S. Herman, J. Spadoro, and M. Peeters. 1999. Efficiencies of four versions of the AMPLICOR HIV-1 MONITOR test for quantification of different subtypes of human immunodeficiency virus type 1. J. Clin. Microbiol. 37:110-116.
23. U.S. Department of Health and Human Services Panel on Clinical Practice for Treatment of HIV Infection. 2002. Guidelines for the use of antiretroviral agents in HIV-infected adults and adolescents. U.S. Department of Health and Human Services, Washington, D.C.
24. van Gemen, B., T. Kievits, R. E. Schukkin, D. van Strijp, L. T. Malek, R. Sooknanan, H. G. Huisman, and P. Lens. 1993. Quantification of HIV-1 RNA in plasma using NASBA during primary infection. J. Virol. Methods 43:177-188.
25. Wei, X., S. K. Ghosh, M. E. Taylor, V. A. Johnson, E. A. Emmini, P. Deutsch, J. D. Lifson, S. Bonhoeffer, M. A. Nowak, B. H. Hahn, M. S. Saag, and G. M. Shaw. 1995. Viral dynamics in human immunodeficiency virus type 1 infection. Nature 373:117-122.
26. Witt, D. J., M. Kemper, A. Stead, C. C. Ginocchio, and A. M. Caliendo. 2000. Relationship of incremental specimen volumes and enhanced detection of human immunodeficiency virus type 1 RNA with nucleic acid amplification technology. J. Clin. Microbiol. 38:85-89.