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Concordance of HIV-1 RNA Values by Amplicor and TaqMan 2.0 in Patients With Confirmed Suppression in Clinical Trials

Discordant viremia results near human immunodeficiency virus type 1 RNA 50 copies/mL by the TaqMan 2.0 assay led to significantly lower efficacy rates in clinical trials and increased patient management decision points compared with the historical standard Amplicor assay. Background.  The COBAS AMPL... Full description

Journal Title: Clinical Infectious Diseases 2016, Vol. 62(7), pp.929-934
Main Author: Garner, Will
Other Authors: White, Kirsten , Szwarcberg, Javier , Mccallister, Scott , Zhong, Lijie , Wulfsohn, Mike
Format: Electronic Article Electronic Article
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ID: ISSN: 1058-4838 ; E-ISSN: 1537-6591 ; DOI: 10.1093/cid/civ1034
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recordid: oxford10.1093/cid/civ1034
title: Concordance of HIV-1 RNA Values by Amplicor and TaqMan 2.0 in Patients With Confirmed Suppression in Clinical Trials
format: Article
creator:
  • Garner, Will
  • White, Kirsten
  • Szwarcberg, Javier
  • Mccallister, Scott
  • Zhong, Lijie
  • Wulfsohn, Mike
subjects:
  • Amplicor
  • Taqman 2. 0
  • Discordant
  • Viremia
ispartof: Clinical Infectious Diseases, 2016, Vol. 62(7), pp.929-934
description: Discordant viremia results near human immunodeficiency virus type 1 RNA 50 copies/mL by the TaqMan 2.0 assay led to significantly lower efficacy rates in clinical trials and increased patient management decision points compared with the historical standard Amplicor assay. Background.  The COBAS AMPLICOR HIV-1 MONITOR Test, version 1.5 (Amplicor) has been replaced with the COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0 (TaqMan 2.0), a real-time polymerase chain reaction human immunodeficiency virus type 1 (HIV-1) assay with higher sensitivity and broader dynamic range. HIV-1 RNA values at the 50 copies/mL cutoff drive major patient management decisions and clinical study outcomes. Methods.  A total of 2217 samples were collected from 1922 HIV-1–infected subjects taking antiretroviral therapy for at least 48 weeks and had at least 2 consecutive samples with HIV-1 RNA
language:
source:
identifier: ISSN: 1058-4838 ; E-ISSN: 1537-6591 ; DOI: 10.1093/cid/civ1034
fulltext: fulltext
issn:
  • 1058-4838
  • 10584838
  • 1537-6591
  • 15376591
url: Link


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titleConcordance of HIV-1 RNA Values by Amplicor and TaqMan 2.0 in Patients With Confirmed Suppression in Clinical Trials
creatorGarner, Will ; White, Kirsten ; Szwarcberg, Javier ; Mccallister, Scott ; Zhong, Lijie ; Wulfsohn, Mike
ispartofClinical Infectious Diseases, 2016, Vol. 62(7), pp.929-934
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subjectAmplicor ; Taqman 2. 0 ; Discordant ; Viremia
descriptionDiscordant viremia results near human immunodeficiency virus type 1 RNA 50 copies/mL by the TaqMan 2.0 assay led to significantly lower efficacy rates in clinical trials and increased patient management decision points compared with the historical standard Amplicor assay. Background.  The COBAS AMPLICOR HIV-1 MONITOR Test, version 1.5 (Amplicor) has been replaced with the COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0 (TaqMan 2.0), a real-time polymerase chain reaction human immunodeficiency virus type 1 (HIV-1) assay with higher sensitivity and broader dynamic range. HIV-1 RNA values at the 50 copies/mL cutoff drive major patient management decisions and clinical study outcomes. Methods.  A total of 2217 samples were collected from 1922 HIV-1–infected subjects taking antiretroviral therapy for at least 48 weeks and had at least 2 consecutive samples with HIV-1 RNA <50 copies/mL by Amplicor from 7 recent clinical trials. HIV-1 RNA results were obtained from the Amplicor and TaqMan 2.0 assays in parallel by a reference laboratory. Results.  The overall concordance between assay results was 96% at the cutoff of 50 copies/mL. However, statistically significant discordance at the 50 copies/mL cutoff was found between the assays for 3.9% of samples (n = 87). By TaqMan 2.0, virologic failure defined as HIV-1 RNA ≥50 copies/mL was reported for 2.8% more samples than Amplicor. Of these 87 samples, 68 samples fell within the predicted range of assay variability. Retesting of HIV-1 RNA by TaqMan 2.0 confirmed the discordance in only 28 of the 87 samples. Conclusions.  The TaqMan 2.0 assay reports fewer subjects below the clinical endpoint of HIV-1 RNA <50 copies/mL in HIV clinical trials than the Amplicor assay. This difference must be considered when assessing disease progression, designing clinical trials, and comparisons with historical trials that used the Amplicor assay.
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titleConcordance of HIV-1 RNA Values by Amplicor and TaqMan 2.0 in Patients With Confirmed Suppression in Clinical Trials
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0Discordant viremia results near human immunodeficiency virus type 1 RNA 50 copies/mL by the TaqMan 2.0 assay led to significantly lower efficacy rates in clinical trials and increased patient management decision points compared with the historical standard Amplicor assay.
1Background.  The COBAS AMPLICOR HIV-1 MONITOR Test, version 1.5 (Amplicor) has been replaced with the COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0 (TaqMan 2.0), a real-time polymerase chain reaction human immunodeficiency virus type 1 (HIV-1) assay with higher sensitivity and broader dynamic range. HIV-1 RNA values at the 50 copies/mL cutoff drive major patient management decisions and clinical study outcomes.
2Methods.  A total of 2217 samples were collected from 1922 HIV-1–infected subjects taking antiretroviral therapy for at least 48 weeks and had at least 2 consecutive samples with HIV-1 RNA <50 copies/mL by Amplicor from 7 recent clinical trials. HIV-1 RNA results were obtained from the Amplicor and TaqMan 2.0 assays in parallel by a reference laboratory.
3Results.  The overall concordance between assay results was 96% at the cutoff of 50 copies/mL. However, statistically significant discordance at the 50 copies/mL cutoff was found between the assays for 3.9% of samples (n = 87). By TaqMan 2.0, virologic failure defined as HIV-1 RNA ≥50 copies/mL was reported for 2.8% more samples than Amplicor. Of these 87 samples, 68 samples fell within the predicted range of assay variability. Retesting of HIV-1 RNA by TaqMan 2.0 confirmed the discordance in only 28 of the 87 samples.
4Conclusions.  The TaqMan 2.0 assay reports fewer subjects below the clinical endpoint of HIV-1 RNA <50 copies/mL in HIV clinical trials than the Amplicor assay. This difference must be considered when assessing disease progression, designing clinical trials, and comparisons with historical trials that used the Amplicor assay.
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abstractDiscordant viremia results near human immunodeficiency virus type 1 RNA 50 copies/mL by the TaqMan 2.0 assay led to significantly lower efficacy rates in clinical trials and increased patient management decision points compared with the historical standard Amplicor assay. Background.  The COBAS AMPLICOR HIV-1 MONITOR Test, version 1.5 (Amplicor) has been replaced with the COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0 (TaqMan 2.0), a real-time polymerase chain reaction human immunodeficiency virus type 1 (HIV-1) assay with higher sensitivity and broader dynamic range. HIV-1 RNA values at the 50 copies/mL cutoff drive major patient management decisions and clinical study outcomes. Methods.  A total of 2217 samples were collected from 1922 HIV-1–infected subjects taking antiretroviral therapy for at least 48 weeks and had at least 2 consecutive samples with HIV-1 RNA <50 copies/mL by Amplicor from 7 recent clinical trials. HIV-1 RNA results were obtained from the Amplicor and TaqMan 2.0 assays in parallel by a reference laboratory. Results.  The overall concordance between assay results was 96% at the cutoff of 50 copies/mL. However, statistically significant discordance at the 50 copies/mL cutoff was found between the assays for 3.9% of samples (n = 87). By TaqMan 2.0, virologic failure defined as HIV-1 RNA ≥50 copies/mL was reported for 2.8% more samples than Amplicor. Of these 87 samples, 68 samples fell within the predicted range of assay variability. Retesting of HIV-1 RNA by TaqMan 2.0 confirmed the discordance in only 28 of the 87 samples. Conclusions.  The TaqMan 2.0 assay reports fewer subjects below the clinical endpoint of HIV-1 RNA <50 copies/mL in HIV clinical trials than the Amplicor assay. This difference must be considered when assessing disease progression, designing clinical trials, and comparisons with historical trials that used the Amplicor assay.
pubOxford University Press
doi10.1093/cid/civ1034
date2016-04-01