BACKGROUND: HIV-1 viral load assays are critical tools to monitor antiretroviral therapy efficacy in HIV-infected patients. Two assays based on real-time PCR are available, the Abbott Real-Time HIV-1 assay (Abbott assay) and the new Roche COBAS(®) AmpliPrep/COBAS(®) TaqMan(®) HIV-1 test, v. 2.0 (TaqMan(®) test v2.0). OBJECTIVES: We have compared the performance of the two assays in 546 clinical plasma specimens of group M strains from Luxembourg and Rwanda. STUDY DESIGN: Our analyses focused on subtype inclusivity and platforms accuracy for 328 low level viremia samples. RESULTS: Strong agreement and linear correlation were observed between the two assays (R(2) = 0.95) over a wide dynamic range. Bland-Altman analysis showed a mean difference of 0.04 log 10 indicating minimal overall viral load quantification differences between both platforms. One subtype C was severely underquantified by TaqMan(®) test v2.0 for which sequence analysis revealed multiple mismatches between the viral sequence and the primer/probe regions. A non significant lower quantification of the Abbott assay was shown for subtype A1 with a mean log 10 difference of 0.24. For specimens under 200 cp/mL, the overall agreement was 90% at the cut-off of 50 cp/mL and 67% at assay's lower limit of detection of 20 and 40 cp/mL. 309 samples were retested by the COBAS(®) AMPLICOR(®) HIV-1 MONITOR Test, v. 1.5 and a lack of agreement between the three assays around their lower limit of quantification was revealed. CONCLUSIONS: Both real-time tests were closely comparable in the quantification of viral load specimens of ten HIV-1 subtypes and recombinant forms.
BACKGROUND:HIV-1 viral load assays are critical tools to monitor antiretroviral therapy efficacy in HIV-infectedpatients. Two assays based on real-time PCR are available, the Abbott Real-Time HIV-1 assay (Abbott assay) and the new Roche COBAS(®) AmpliPrep/COBAS(®) TaqMan(®) HIV-1 test, v. 2.0 (TaqMan(®) test v2.0). OBJECTIVES: We have compared the performance of the two assays in 546 clinical plasma specimens of group M strains from Luxembourg and Rwanda. STUDY DESIGN: Our analyses focused on subtype inclusivity and platforms accuracy for 328 low level viremia samples. RESULTS: Strong agreement and linear correlation were observed between the two assays (R(2) = 0.95) over a wide dynamic range. Bland-Altman analysis showed a mean difference of 0.04 log 10 indicating minimal overall viral load quantification differences between both platforms. One subtype C was severely underquantified by TaqMan(®) test v2.0 for which sequence analysis revealed multiple mismatches between the viral sequence and the primer/probe regions. A non significant lower quantification of the Abbott assay was shown for subtype A1 with a mean log 10 difference of 0.24. For specimens under 200 cp/mL, the overall agreement was 90% at the cut-off of 50 cp/mL and 67% at assay's lower limit of detection of 20 and 40 cp/mL. 309 samples were retested by the COBAS(®) AMPLICOR(®) HIV-1 MONITOR Test, v. 1.5 and a lack of agreement between the three assays around their lower limit of quantification was revealed. CONCLUSIONS: Both real-time tests were closely comparable in the quantification of viral load specimens of ten HIV-1 subtypes and recombinant forms.
Authors: Luke C Swenson; Bryan Cobb; Anna Maria Geretti; P Richard Harrigan; Mario Poljak; Carole Seguin-Devaux; Chris Verhofstede; Marc Wirden; Alessandra Amendola; Jurg Boni; Thomas Bourlet; Jon B Huder; Jean-Claude Karasi; Snjezana Zidovec Lepej; Maja M Lunar; Odette Mukabayire; Rob Schuurman; Janez Tomazic; Kristel Van Laethem; Linos Vandekerckhove; Annemarie M J Wensing Journal: J Clin Microbiol Date: 2013-12-04 Impact factor: 5.948
Authors: Malaya K Sahoo; Vici Varghese; Elizabeth White; Meg Winslow; David A Katzenstein; Robert W Shafer; Benjamin A Pinsky Journal: J Clin Microbiol Date: 2016-08-17 Impact factor: 5.948
Authors: Cheryl Jennings; Brian Harty; Suzanne Granger; Carrie Wager; John A Crump; Susan A Fiscus; James W Bremer Journal: J Clin Microbiol Date: 2012-06-12 Impact factor: 5.948
Authors: Patrick Ryscavage; Sean Kelly; Jonathan Z Li; P Richard Harrigan; Babafemi Taiwo Journal: Antimicrob Agents Chemother Date: 2014-04-14 Impact factor: 5.191
Authors: Kimberly A Sollis; Pieter W Smit; Susan Fiscus; Nathan Ford; Marco Vitoria; Shaffiq Essajee; David Barnett; Ben Cheng; Suzanne M Crowe; Thomas Denny; Alan Landay; Wendy Stevens; Vincent Habiyambere; Jos Perrins; Rosanna W Peeling Journal: PLoS One Date: 2014-02-18 Impact factor: 3.240