Evaluation of the Abbott m2000 RealTime human immunodeficiency virus type 1 (HIV-1) assay for HIV load monitoring in South Africa compared to the Roche Cobas AmpliPrep-Cobas Amplicor, Roche Cobas AmpliPrep-Cobas TaqMan HIV-1, and BioMerieux NucliSENS EasyQ HIV-1 assays

Journal of Clinical Microbiology

Volumn 47, Issue 7, 2009, Pages 2209-2217

  Scott, Lesley E ^a   Noble, Lara D ^a   Moloi, Jackie ^a   Erasmus, Linda ^a   Venter, Willem D F ^b   Stevens, Wendy ^a  

^a UNIVERSITY OF THE WITWATERSRAND   (South Africa)

^b UNIVERSITY OF THE WITWATERSRAND   (South Africa)

Author keywords

[No Author keywords available]

Indexed keywords

ACCURACY; ARTICLE; CONTROLLED STUDY; GENE AMPLIFICATION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; INTERMETHOD COMPARISON; LABORATORY AUTOMATION; MAJOR CLINICAL STUDY; NONHUMAN; PRIORITY JOURNAL; REAL TIME POLYMERASE CHAIN REACTION; SOUTH AFRICA; VIRUS LOAD; VIRUS TYPING;

HIV INFECTIONS; HIV-1; HUMANS; MOLECULAR DIAGNOSTIC TECHNIQUES; REAGENT KITS, DIAGNOSTIC; SOUTH AFRICA; VIRAL LOAD;

HUMAN IMMUNODEFICIENCY VIRUS 1;

EID: 67650021214     PISSN: 00951137     EISSN: None     Source Type: Journal    
DOI: 10.1128/JCM.01761-08     Document Type: Article

References (48)

1. Alaeus, A., E. Lilja, S. Herman, J. Spadoro, J. Wang, and J. Albert. 1999. Assay of plasma samples representing different HIV-1 genetic subtypes: an evaluation of new versions of the Amplicor HIV-1 monitor assay. AIDS Res. Hum Retrovir. 15:889-894.
2. Bekker, L. G., L. Myer, C. Orrell, S. Lawn, and R. Wood. 2006. Rapid scale-up of a community-based HIV treatment service: programme performance over 3 consecutive years in Guguletu, South Africa. S. Afr. Med. J. 96:315-320.
3. Bland, J. M., and D. G. Altman. 1999. Measuring agreement in method comparison studies. Stat. Methods Med. Res. 8:135-160.
4. Bonnet, G., S. Tyagi, A. Libchaber, and F. R. Kramer. 1999. Thermodynamic basis of the enhanced specificity of structured DNA probes. Proc. Natl. Acad. Sci. USA 96:6171-6176.
5. Brambilla, D., S. Granger, and J. Bremer. 2000. Abstr. 7th Conf. Retrovir. Opportunist. Infect., abstr. 774.
6. Braun, P., R. Ehret, F. Wiesmann, F. Zabbai, M. Knickmann, R. Kuhn, S. Thamm, G. Warnat, and H. Knechten. 2007. Comparison of four commercial quantitative HIV-1 assays for viral load monitoring in clinical daily routine. Clin. Chem. Lab. Med. 45:93-99.
7. Damond, F., B. Roquebert, A. Benard, G. Collin, M. Miceli, P. Yeni, F. Brun-Vezinet, and D. Descamps. 2007. Human immunodeficiency virus type 1 (HIV-1) plasma load discrepancies between the Roche COBAS AMPLICOR HIV-1 MONITOR Version 1.5 and the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 assays. J. Clin. Microbiol. 45:3436-3438.
8. de Mendoza, C., M. Koppelman, B. Montes, V. Ferre, V. Soriano, H. Cuypers, M. Segondy, and T. Oosterlaken. 2005. Multicenter evaluation of the NucliSens EasyQ HIV-1 v1.1 assay for the quantitative detection of HIV-1 RNA in plasma. J. Virol. Methods 127:54-59.
9. Dorrington, R. E. 2002. How many people are currently infected with HIV in South Africa? S. Afr. Med. J. 92:196-197.
10. Drosten, C., M. Panning, J. F. Drexler, F. Hansel, C. Pedroso, J. Yeats, L. K. de Souza Luna, M. Samuel, B. Liedigk, U. Lippert, M. Sturmer, H. W. Doerr, C. Brites, and W. Preiser. 2006. Ultrasensitive monitoring of HIV-1 viral load by a low-cost real-time reverse transcription-PCR assay with internal control for the 5′ long terminal repeat domain. Clin. Chem. 52:1258-1266.
11. Fiscus, S. A., B. Cheng, S. M. Crowe, L. Demeter, C. Jennings, V. Miller, R. Respess, and W. Stevens. 2006. HIV-1 viral load assays for resource-limited settings. PLoS Med. 3:e417.
12. Garcia-Diaz, A., G. S. Clewley, C. L. Booth, W. Labett, N. McAllister, and A. M. Geretti. 2006. Comparative evaluation of the performance of the Abbott real-time human immunodeficiency virus type 1 (HIV-1) assay for measurement of HIV-1 plasma viral load following automated specimen preparation. J. Clin. Microbiol. 44:1788-1791.
13. Gottesman, B. S., Z. Grossman, M. Lorber, I. Levi, P. Shitrit, M. Katzir, E. Shahar, G. Gottesman, and M. Chowers. 2006. Comparative performance of the Amplicor HIV-1 Monitor assay versus NucliSens EasyQ in HIV subtype C-infected patients. J. Med. Virol. 78:883-887.
14. Griffith, B. P., and D. R. Mayo. 2006. Increased levels of HIV RNA detected in samples with viral loads close to the detection limit collected in plasma preparation tubes (PPT). J. Clin. Virol. 35:197-200.
15. Gueudin, M., J. C. Plantier, V. Lemee, M. P. Schmitt, L. Chartier, T. Bourlet, A. Ruffault, F. Damond, M. Vray, and F. Simon. 2007. Evaluation of the Roche Cobas TaqMan and Abbott RealTime extraction-quantification systems for HIV-1 subtypes. J. Acquir. Immune Defic. Syndr. 44:500-505.
16. Huang, S., J. Salituro, N. Tang, K. C. Luk, J. Hackett, Jr., P. Swanson, G. Cloherty, W. B. Mak, J. Robinson, and K. Abravaya. 2007. Thermodynamically modulated partially double-stranded linear DNA probe design for homogeneous real-time PCR. Nucleic Acids Res. 35:e101.
17. Katsoulidou, A., M. Petrodaskalaki, V. Sypsa, E. Papachristou, C. G. Anastassopoulou, P. Gargalianos, A. Karafoulidou, M. Lazanas, T. Kordossis, A. Andoniadou, and A. Hatzakis. 2006. Evaluation of the clinical sensitivity for the quantification of human immunodeficiency virus type 1 RNA in plasma: comparison of the new COBAS TaqMan HIV-1 with three current HIVRNA assays - LCx HIV RNA quantitative, VERSANT HIV-1 RNA 3.0 (bDNA) and COBAS AMPLICOR HIV-1 Monitor v1.5. J. Virol. Methods 131:168-174.
18. Livak, K. J., S. J. Flood, J. Marmaro, W. Giusti, and K. Deetz. 1995. Oligonucleotides with fluorescent dyes at opposite ends provide a quenched probe system useful for detecting PCR product and nucleic acid hybridization. PCR Methods Appl. 4:357-362.
19. Luk, K. C., S. G. Devare, and J. R. Hackett, Jr. 2007. Partially double-stranded linear DNA probes: Novel design for sensitive detection of genetically polymorphic targets. J. Virol. Methods 144:1-11.
20. MacDougall, D. S. 1996. Quantitative measurement of HIV RNA: techniques & clinical applications. J. Int. Assoc. Physicians AIDS Care 2:9-14.
21. Malmsten, A., X. W. Shao, S. Sjodahl, E. L. Fredriksson, I. Pettersson, T. Leitner, C. F. Kallander, E. Sandstrom, and J. S. Gronowitz. 2005. Improved HIV-1 viral load determination based on reverse transcriptase activity recovered from human plasma. J. Med. Virol. 76:291-296.
22. Marshall, R., M. Chernesky, D. Jang, E. W. Hook, C. P. Cartwright, B. Howell-Adams, S. Ho, J. Welk, J. Lai-Zhang, J. Brashear, B. Diedrich, K. Otis, E. Webb, J. Robinson, and H. Yu. 2007. Characteristics of the m2000 automated sample preparation and multiplex real-time PCR system for detection of Chlamydia trachomatis and Neisseria gonorrhoeae. J. Clin. Microbiol. 45:747-751.
23. Martin, D. 2000. Appropriate laboratory monitoring of HIV. S. Afr. Med. J. 90:33-36.
24. National Department of Health, South Africa. 2004. ART treatment guidelines. National Department of Health, Pretoria, South Africa. http://www.doh.gov.za/docs/factsheets/guidelines/artguidelines04.
25. Ojikutu, B., A. T. Makadzange, and T. Gaolathe. 2008. Scaling up ART treatment capacity: lessons learned from South Africa, Zimbabwe, and Botswana. Curr. Infect. Dis. Rep. 10:69-73.
26. Oliver, A. R., S. F. Pereira, and D. A. Clark. 2007. Comparative evaluation of the automated Roche TaqMan real-time quantitative human immunodeficiency virus type 1 RNA PCR assay and the Roche AMPLICOR version 1.5 conventional PCR assay. J. Clin. Microbiol. 45:3616-3619.
27. Perrin, L., J. M. Pawlotsky, M. Bouvier-Alias, C. Sarrazin, S. Zeuzem, and G. Colucci. 2006. Multicenter performance evaluation of a new TaqMan PCR assay for monitoring human immunodeficiency virus RNA load. J. Clin. Microbiol. 44:4371-4375.
28. Peter, J. B., and R. A. Blum. 2002. Monitoring HIV viral loads in the United States: recent trends and methodologies. J. Acquir. Immune Defic. Syndr. 30:261-262.
29. Schumacher, W., E. Frick, M. Kauselmann, V. Maier-Hoyle, R. van der Vliet, and R. Babiel. 2007. Fully automated quantification of human immunodeficiency virus (HIV) type 1 RNA in human plasma by the COBAS AmpliPrep/COBAS TaqMan system. J. Clin. Virol. 38:304-312.
30. Schutten, M., E. Fries, C. Burghoorn-Maas, and H. G. Niesters. 2007. Evaluation of the analytical performance of the new Abbott RealTime RTPCRs for the quantitative detection of HCV and HIV-1 RNA. J. Clin. Virol. 40:99-104.
31. Scott, L. E., J. S. Galpin, and D. K. Glencross. 2003. Multiple method comparison: statistical model using percentage similarity. Cytometry 54B:46-53.
32. Stevens, G., N. Rekhviashvili, L. E. Scott, R. Gonin, and W. Stevens. 2005. Evaluation of two commercially available, inexpensive alternative assays used for assessing viral load in a cohort of human immunodeficiency virus type 1 subtype C-infected patients from South Africa. J. Clin. Microbiol. 43:857-861.
33. Stevens, W., P. Horsfield, and L. E. Scott. 2007. Evaluation of the performance of the automated NucliSENS easyMAG and EasyQ systems versus the Roche AmpliPrep-AMPLICOR combination for high-throughput monitoring of human immunodeficiency virus load. J. Clin. Microbiol. 45:1244-1249.
34. Stevens, W., T. Wiggill, P. Horsfield, L. Coetzee, and L. E. Scott. 2005. Evaluation of the NucliSens EasyQ assay in HIV-1-infected individuals in South Africa. J. Virol. Methods 124:105-110.
35. Swanson, P., C. de Mendoza, Y. Joshi, A. Golden, R. L. Hodinka, V. Soriano, S. G. Devare, and J. Hackett, Jr. 2005. Impact of human immunodeficiency virus type 1 (HIV-1) genetic diversity on performance of four commercial viral load assays: LCx HIV RNA Quantitative, AMPLICOR HIV-1 MONITOR v1.5, VERSANT HIV-1 RNA 3.0, and NucliSens HIV-1 QT. J. Clin. Microbiol. 43:3860-3868.
36. Swanson, P., B. J. Harris, V. Holzmayer, S. G. Devare, G. Schochetman, and J. Hackett, Jr. 2000. Quantification of HIV-1 group M (subtypes A-G) and group O by the LCx HIV RNA quantitative assay. J. Virol. Methods 89:97-108.
37. Swanson, P., V. Holzmayer, S. Huang, P. Hay, A. Adebiyi, P. Rice, K. Abravaya, S. Thamm, S. G. Devare, and J. Hackett, Jr. 2006. Performance of the automated Abbott RealTime HIV-1 assay on a genetically diverse panel of specimens from London: comparison to VERSANT HIV-1 RNA 3.0, AMPLICOR HIV-1 MONITOR v1.5, and LCx HIV RNA Quantitative assays. J. Virol. Methods 137:184-192.
38. Swanson, P., S. Huang, K. Abravaya, C. de Mendoza, V. Soriano, S. G. Devare, and J. Hackett, Jr. 2007. Evaluation of performance across the dynamic range of the Abbott RealTime HIV-1 assay as compared to VERSANT HIV-1 RNA 3.0 and AMPLICOR HIV-1 MONITOR v1.5 using serial dilutions of 39 group M and O viruses. J. Virol. Methods 141:49-57.
39. Swanson, P., S. Huang, V. Holzmayer, P. Bodelle, J. Yamaguchi, C. Brennan, R. Badaro, C. Brites, K. Abravaya, S. G. Devare, and J. Hackett, Jr. 2006. Performance of the automated Abbott RealTime HIV-1 assay on a genetically diverse panel of specimens from Brazil. J. Virol. Methods 134:237-243.
40. Tyagi, S., and F. R. Kramer. 1996. Molecular beacons: probes that fluoresce upon hybridization. Nat. Biotechnol. 14:303-308.
41. UNAIDS. 2006. UNAIDS global report 2006. UNAIDS, Geneva, Switzerland. http://www.unaids.org/en/KnowledgeCentre/HIVData/GlobalReport/2006.
42. Reference deleted.
43. Wallis, C., C. Bell, R. Boulme, I. Sanne, F. Venter, M. Papathanasopoulos, and W. Stevens. 2007. Abstr. Conf. Retrovir. Opportunist. Infect., abstr. 661.
44. Wittek, M., M. Sturmer, H. W. Doerr, and A. Berger. 2007. Molecular assays for monitoring HIV infection and antiretroviral therapy. Expert Rev. Mol. Diagn. 7:237-246.
45. Wolff, D., and A. Gerritzen. 2007. Comparison of the Roche COBAS Amplicor Monitor, Roche COBAS AmpliPrep/COBAS Taqman and Abbott RealTime Test assays for quantification of hepatitis C virus and HIV RNA. Clin. Chem. Lab. Med. 45:917-922.
46. World Health Organization. 2006. ART for HIV infection in adults and adolescents in resource-limited settings: toward universal access, 2006 revision. World Health Organization, Geneva, Switzerland. http://www.who.int/ hiv/mediacentre/fs-2006guidelines-art/.
47. Xu, S., A. Song, X. Li, J. Li, Z. Bao, P. Mao, Q. Zhao, and Y. Wang. 2008. Performance of the Abbott RealTime HIV-1 assay for quantification of HIV-1 clades prevalent in China. J. Clin. Virol. 41:305-309.
48. Yilmaz, G. 2001. Diagnosis of HIV infection and laboratory monitoring of its therapy. J. Clin. Virol. 21:187-196.