Comparative Evaluation of the Performance of the Abbott RealTime HIV-1 Assay for Measurement of HIV-1 Plasma Viral Load on Genetically Diverse Samples from Greece

Overview

Journal Virol J

Publisher Biomed Central

Specialty Microbiology

Date 2011 Jan 12

PMID 21219667

Citations 4

Authors

Antigoni Katsoulidou

Chrysoula Rokka

Catherine Issaris

Catherine Haida

Kimon Tzannis

Vana Sypsa

Maria Detsika

Dimitrios Paraskevis

Angelos Hatzakis

Affiliations

Soon will be listed here.

Abstract

Background: HIV-1 is characterized by increased genetic heterogeneity which tends to hinder the reliability of detection and accuracy of HIV-1 RNA quantitation assays.

Methods: In this study, the Abbott RealTime HIV-1 (Abbott RealTime) assay was compared to the Roche Cobas TaqMan HIV-1 (Cobas TaqMan) and the Siemens Versant HIV-1 RNA 3.0 (bDNA 3.0) assays, using clinical samples of various viral load levels and subtypes from Greece, where the recent epidemiology of HIV-1 infection has been characterized by increasing genetic diversity and a marked increase in subtype A genetic strains among newly diagnosed infections.

Results: A high correlation was observed between the quantitative results obtained by the Abbott RealTime and the Cobas TaqMan assays. Viral load values quantified by the Abbott RealTime were on average lower than those obtained by the Cobas TaqMan, with a mean (SD) difference of -0.206 (0.298) log(10) copies/ml. The mean differences according to HIV-1 subtypes between the two techniques for samples of subtype A, B, and non-A/non-B were 0.089, -0.262, and -0.298 log(10) copies/ml, respectively. Overall, differences were less than 0.5 log(10) for 85% of the samples, and >1 log(10) in only one subtype B sample. Similarly, Abbott RealTime and bDNA 3.0 assays yielded a very good correlation of quantitative results, whereas viral load values assessed by the Abbott RealTime were on average higher (mean (SD) difference: 0.160 (0.287) log(10) copies/ml). The mean differences according to HIV-1 subtypes between the two techniques for subtype A, B and non-A/non-B samples were 0.438, 0.105 and 0.191 log(10) copies/ml, respectively. Overall, the majority of samples (86%) differed by less than 0.5 log(10), while none of the samples showed a deviation of more than 1.0 log(10).

Conclusions: In an area of changing HIV-1 subtype pattern, the Abbott RealTime assay showed a high correlation and good agreement of results when compared both to the Cobas TaqMan and bDNA 3.0 assays, for all HIV-1 subtypes tested. All three assays could determine viral load from samples of different HIV-1 subtypes adequately. However, assay variation should be taken into account when viral load monitoring of the same individual is assessed by different systems.

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References

Mellors J, Munoz A, Giorgi J, Margolick J, Tassoni C, Gupta P . Plasma viral load and CD4+ lymphocytes as prognostic markers of HIV-1 infection. Ann Intern Med. 1997; 126(12):946-54. DOI: 10.7326/0003-4819-126-12-199706150-00003. View

Palmer S, Wiegand A, Maldarelli F, Bazmi H, Mican J, Polis M . New real-time reverse transcriptase-initiated PCR assay with single-copy sensitivity for human immunodeficiency virus type 1 RNA in plasma. J Clin Microbiol. 2003; 41(10):4531-6. PMC: 254331. DOI: 10.1128/JCM.41.10.4531-4536.2003. View

Damond F, Roquebert B, Benard A, Collin G, Miceli M, Yeni P . 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. 2007; 45(10):3436-8. PMC: 2045351. DOI: 10.1128/JCM.00973-07. View

Sloma C, Germer J, Gerads T, Mandrekar J, Mitchell P, Yao J . Comparison of the Abbott realtime human immunodeficiency virus type 1 (HIV-1) assay to the Cobas AmpliPrep/Cobas TaqMan HIV-1 test: workflow, reliability, and direct costs. J Clin Microbiol. 2009; 47(4):889-95. PMC: 2668302. DOI: 10.1128/JCM.02231-08. View

Colson P, Solas C, Moreau J, Motte A, Henry M, Tamalet C . Impaired quantification of plasma HIV-1 RNA with a commercialized real-time PCR assay in a couple of HIV-1-infected individuals. J Clin Virol. 2007; 39(3):226-9. DOI: 10.1016/j.jcv.2007.04.007. View

Swanson P, de Mendoza C, Joshi Y, Golden A, Hodinka R, Soriano V . 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. 2005; 43(8):3860-8. PMC: 1233972. DOI: 10.1128/JCM.43.8.3860-3868.2005. View

Swanson P, Huang S, Holzmayer V, Bodelle P, Yamaguchi J, Brennan C . Performance of the automated Abbott RealTime HIV-1 assay on a genetically diverse panel of specimens from Brazil. J Virol Methods. 2006; 134(1-2):237-43. DOI: 10.1016/j.jviromet.2006.01.012. View

Foulongne V, Montes B, Didelot-Rousseau M, Segondy M . Comparison of the LCx human immunodeficiency virus (HIV) RNA quantitative, RealTime HIV, and COBAS AmpliPrep-COBAS TaqMan assays for quantitation of HIV type 1 RNA in plasma. J Clin Microbiol. 2006; 44(8):2963-6. PMC: 1594638. DOI: 10.1128/JCM.00341-06. View

Gueudin M, Plantier J, Lemee V, Schmitt M, Chartier L, Bourlet T . Evaluation of the Roche Cobas TaqMan and Abbott RealTime extraction-quantification systems for HIV-1 subtypes. J Acquir Immune Defic Syndr. 2007; 44(5):500-5. DOI: 10.1097/QAI.0b013e31803260df. View

10.

Zhang M, Versalovic J . HIV update. Diagnostic tests and markers of disease progression and response to therapy. Am J Clin Pathol. 2003; 118 Suppl:S26-32. DOI: 10.1309/LR1B-MHM7-GDWG-T1EU. View

11.

Scott L, Noble L, Moloi J, Erasmus L, Venter W, Stevens W . 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.... J Clin Microbiol. 2009; 47(7):2209-17. PMC: 2708481. DOI: 10.1128/JCM.01761-08. View

12.

Sun R, Ku J, Jayakar H, Kuo J, Brambilla D, Herman S . Ultrasensitive reverse transcription-PCR assay for quantitation of human immunodeficiency virus type 1 RNA in plasma. J Clin Microbiol. 1998; 36(10):2964-9. PMC: 105095. DOI: 10.1128/JCM.36.10.2964-2969.1998. View

13.

Gazzard B, Anderson J, Babiker A, Boffito M, Brook G, Brough G . British HIV Association Guidelines for the treatment of HIV-1-infected adults with antiretroviral therapy 2008. HIV Med. 2008; 9(8):563-608. DOI: 10.1111/j.1468-1293.2008.00636.x. View

14.

Bustin S . Absolute quantification of mRNA using real-time reverse transcription polymerase chain reaction assays. J Mol Endocrinol. 2000; 25(2):169-93. DOI: 10.1677/jme.0.0250169. View

15.

Bland J, Altman D . Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986; 1(8476):307-10. View

16.

Collins M, Irvine B, Tyner D, Fine E, Zayati C, Chang C . A branched DNA signal amplification assay for quantification of nucleic acid targets below 100 molecules/ml. Nucleic Acids Res. 1997; 25(15):2979-84. PMC: 146852. DOI: 10.1093/nar/25.15.2979. View

17.

Swanson P, Huang S, Abravaya K, de Mendoza C, Soriano V, Devare S . 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. 2006; 141(1):49-57. DOI: 10.1016/j.jviromet.2006.11.026. View

18.

Mylonakis E, Paliou M, Rich J . Plasma viral load testing in the management of HIV infection. Am Fam Physician. 2001; 63(3):483-90, 495-6. View

19.

Drosten C, Seifried E, Roth W . TaqMan 5'-nuclease human immunodeficiency virus type 1 PCR assay with phage-packaged competitive internal control for high-throughput blood donor screening. J Clin Microbiol. 2001; 39(12):4302-8. PMC: 88540. DOI: 10.1128/JCM.39.12.4302-4308.2001. View

20.

Tang N, Huang S, Salituro J, Mak W, Cloherty G, Johanson J . A RealTime HIV-1 viral load assay for automated quantitation of HIV-1 RNA in genetically diverse group M subtypes A-H, group O and group N samples. J Virol Methods. 2007; 146(1-2):236-45. DOI: 10.1016/j.jviromet.2007.07.003. View