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Repeat testing of low-level HIV-1 RNA: assay performance and implementation in clinical trials

OBJECTIVE:: Assess the performance of HIV-1 RNA repeat testing of stored samples in cases of low-level viremia during clinical trials. DESIGN:: Prospective and retrospective analysis of randomized clinical trial samples and reference standards. METHODS:: To evaluate assay variability of the Cobas Am... Full description

Journal Title: AIDS 2018, Vol.32(8), pp.1053-1057
Main Author: White, J., Kirsten
Other Authors: Garner, D., Will , Wei, D., Lilian , Eron, D., Joseph , Zhong, D., Lijie , Miller, D., Michael , Martin, D., Hal , Plummer, D., Andrew , Tran-Muchowski, D., Cecilia , Lindstrom, D., Kim , Porter, D., James , Piontkowsky, D., David , Light, D., Angela , Reiske, D., Heinz , Quirk, D., Erin
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ID: ISSN: 0269-9370 ; DOI: 10.1097/QAD.0000000000001779
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recordid: ovid10.1097/QAD.0000000000001779
title: Repeat testing of low-level HIV-1 RNA: assay performance and implementation in clinical trials
format: Article
creator:
  • White, J., Kirsten
  • Garner, D., Will
  • Wei, D., Lilian
  • Eron, D., Joseph
  • Zhong, D., Lijie
  • Miller, D., Michael
  • Martin, D., Hal
  • Plummer, D., Andrew
  • Tran-Muchowski, D., Cecilia
  • Lindstrom, D., Kim
  • Porter, D., James
  • Piontkowsky, D., David
  • Light, D., Angela
  • Reiske, D., Heinz
  • Quirk, D., Erin
subjects:
  • Hiv -- Genetic Aspects
  • Rna -- Research
  • Bioassay -- Usage
  • Viremia -- Care And Treatment
ispartof: AIDS, 2018, Vol.32(8), pp.1053-1057
description: OBJECTIVE:: Assess the performance of HIV-1 RNA repeat testing of stored samples in cases of low-level viremia during clinical trials. DESIGN:: Prospective and retrospective analysis of randomized clinical trial samples and reference standards. METHODS:: To evaluate assay variability of the Cobas AmpliPrep/Cobas TaqMan HIV-1 Test, v2.0, three separate sources of samples were utilized: the World Health Organization (WHO) HIV reference standard (assayed using 50 independent measurements at six viral loads
language:
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identifier: ISSN: 0269-9370 ; DOI: 10.1097/QAD.0000000000001779
fulltext: fulltext
issn:
  • 0269-9370
  • 02699370
url: Link


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titleRepeat testing of low-level HIV-1 RNA: assay performance and implementation in clinical trials
creatorWhite, J., Kirsten ; Garner, D., Will ; Wei, D., Lilian ; Eron, D., Joseph ; Zhong, D., Lijie ; Miller, D., Michael ; Martin, D., Hal ; Plummer, D., Andrew ; Tran-Muchowski, D., Cecilia ; Lindstrom, D., Kim ; Porter, D., James ; Piontkowsky, D., David ; Light, D., Angela ; Reiske, D., Heinz ; Quirk, D., Erin
ispartofAIDS, 2018, Vol.32(8), pp.1053-1057
identifierISSN: 0269-9370 ; DOI: 10.1097/QAD.0000000000001779
descriptionOBJECTIVE:: Assess the performance of HIV-1 RNA repeat testing of stored samples in cases of low-level viremia during clinical trials. DESIGN:: Prospective and retrospective analysis of randomized clinical trial samples and reference standards. METHODS:: To evaluate assay variability of the Cobas AmpliPrep/Cobas TaqMan HIV-1 Test, v2.0, three separate sources of samples were utilized: the World Health Organization (WHO) HIV reference standard (assayed using 50 independent measurements at six viral loads <200 copies/ml), retrospective analysis of four to six aliquots of plasma samples from four clinical trial participants, and prospective repeat testing of 120 samples from participants in randomized trials with low-level viremia. RESULTS:: The TaqMan assay on the WHO HIV-1 RNA standards at viral loads <200 copies/ml performed within the expected variability according to assay specifications. However, standards with low viral loads of 36 and 18 copies/ml reported values of ≥ 50 copies/ml in 66 and 18% of tests, respectively. In participants treated with antiretrovirals who had unexpected viremia of 50–200 copies/ml after achieving <50 copies/ml, retesting of multiple aliquots of stored plasma found <50 copies/ml in nearly all cases upon retesting (14/15; 93%). Repeat testing was prospectively implemented in four clinical trials for all samples with virologic rebound of 50–200 copies/ml (n = 120 samples from 92 participants) from which 42% (50/120) had a retest result of less than 50 copies/ml and 58% (70/120) retested ≥ 50 copies/ml. CONCLUSION:: The TaqMan HIV-1 RNA assay shows variability around 50 copies/ml that affects clinical trial results and may impact clinical practice. In participants with a history of viral load suppression, unexpected low-level viremia may be because of assay variability rather than low drug adherence or true virologic failure. Retesting a stored aliquot of the same sample may differentiate between assay variability and virologic failure as the source of viremia. This retesting strategy could save time, money, and anxiety for patients and their providers, as well as decrease follow-up clinic visits without increasing the risk of virologic failure and resistance development.
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1Garner, D, Will
2Wei, D, Lilian
3Eron, D, Joseph
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6Martin, D, Hal
7Plummer, D, Andrew
8Tran-Muchowski, D, Cecilia
9Lindstrom, D, Kim
10Porter, D, James
11Piontkowsky, D, David
12Light, D, Angela
13Reiske, D, Heinz
14Quirk, D, Erin
titleRepeat testing of low-level HIV-1 RNA: assay performance and implementation in clinical trials
descriptionOBJECTIVE:: Assess the performance of HIV-1 RNA repeat testing of stored samples in cases of low-level viremia during clinical trials. DESIGN:: Prospective and retrospective analysis of randomized clinical trial samples and reference standards. METHODS:: To evaluate assay variability of the Cobas AmpliPrep/Cobas TaqMan HIV-1 Test, v2.0, three separate sources of samples were utilized: the World Health Organization (WHO) HIV reference standard (assayed using 50 independent measurements at six viral loads <200 copies/ml), retrospective analysis of four to six aliquots of plasma samples from four clinical trial participants, and prospective repeat testing of 120 samples from participants in randomized trials with low-level viremia. RESULTS:: The TaqMan assay on the WHO HIV-1 RNA standards at viral loads <200 copies/ml performed within the expected variability according to assay specifications. However, standards with low viral loads of 36 and 18 copies/ml reported values of ≥ 50 copies/ml in 66 and 18% of tests, respectively. In participants treated with antiretrovirals who had unexpected viremia of 50–200 copies/ml after achieving <50 copies/ml, retesting of multiple aliquots of stored plasma found <50 copies/ml in nearly all cases upon retesting (14/15; 93%). Repeat testing was prospectively implemented in four clinical trials for all samples with virologic rebound of 50–200 copies/ml (n = 120 samples from 92 participants) from which 42% (50/120) had a retest result of less than 50 copies/ml and 58% (70/120) retested ≥ 50 copies/ml. CONCLUSION:: The TaqMan HIV-1 RNA assay shows variability around 50 copies/ml that affects clinical trial results and may impact clinical practice. In participants with a history of viral load suppression, unexpected low-level viremia may be because of assay variability rather than low drug adherence or true virologic failure. Retesting a stored aliquot of the same sample may differentiate between assay variability and virologic failure as the source of viremia. This retesting strategy could save time, money, and anxiety for patients and their providers, as well as decrease follow-up clinic visits without increasing the risk of virologic failure and resistance development.
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010.1097/QAD.0000000000001779
1Copyright © 2018 Wolters Kluwer Health, Inc.
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titleRepeat testing of low-level HIV-1 RNA: assay performance and implementation in clinical trials
authorWhite, J., Kirsten ; Garner, D., Will ; Wei, D., Lilian ; Eron, D., Joseph ; Zhong, D., Lijie ; Miller, D., Michael ; Martin, D., Hal ; Plummer, D., Andrew ; Tran-Muchowski, D., Cecilia ; Lindstrom, D., Kim ; Porter, D., James ; Piontkowsky, D., David ; Light, D., Angela ; Reiske, D., Heinz ; Quirk, D., Erin
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7Plummer, D., Andrew
8Tran-Muchowski, D., Cecilia
9Lindstrom, D., Kim
10Porter, D., James
11Piontkowsky, D., David
12Light, D., Angela
13Reiske, D., Heinz
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abstractOBJECTIVE:: Assess the performance of HIV-1 RNA repeat testing of stored samples in cases of low-level viremia during clinical trials. DESIGN:: Prospective and retrospective analysis of randomized clinical trial samples and reference standards. METHODS:: To evaluate assay variability of the Cobas AmpliPrep/Cobas TaqMan HIV-1 Test, v2.0, three separate sources of samples were utilized: the World Health Organization (WHO) HIV reference standard (assayed using 50 independent measurements at six viral loads <200 copies/ml), retrospective analysis of four to six aliquots of plasma samples from four clinical trial participants, and prospective repeat testing of 120 samples from participants in randomized trials with low-level viremia. RESULTS:: The TaqMan assay on the WHO HIV-1 RNA standards at viral loads <200 copies/ml performed within the expected variability according to assay specifications. However, standards with low viral loads of 36 and 18 copies/ml reported values of ≥ 50 copies/ml in 66 and 18% of tests, respectively. In participants treated with antiretrovirals who had unexpected viremia of 50–200 copies/ml after achieving <50 copies/ml, retesting of multiple aliquots of stored plasma found <50 copies/ml in nearly all cases upon retesting (14/15; 93%). Repeat testing was prospectively implemented in four clinical trials for all samples with virologic rebound of 50–200 copies/ml (n = 120 samples from 92 participants) from which 42% (50/120) had a retest result of less than 50 copies/ml and 58% (70/120) retested ≥ 50 copies/ml. CONCLUSION:: The TaqMan HIV-1 RNA assay shows variability around 50 copies/ml that affects clinical trial results and may impact clinical practice. In participants with a history of viral load suppression, unexpected low-level viremia may be because of assay variability rather than low drug adherence or true virologic failure. Retesting a stored aliquot of the same sample may differentiate between assay variability and virologic failure as the source of viremia. This retesting strategy could save time, money, and anxiety for patients and their providers, as well as decrease follow-up clinic visits without increasing the risk of virologic failure and resistance development.
pubCopyright © 2018 Wolters Kluwer Health, Inc.
doi10.1097/QAD.0000000000001779
eissn14735571
date2018-05-15