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A pilot evaluation of whole blood finger-prick sampling for point-of-care HIV viral load measurement: the UNICORN study

There is a global need for HIV viral load point-of-care (PoC) assays to monitor patients receiving antiretroviral therapy. UNICORN was the first study of an off-label protocol using whole blood finger-prick samples tested with and without a simple three minute spin using a clinic-room microcentrifug...

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Autores principales: Fidler, Sarah, Lewis, Heather, Meyerowitz, Jodi, Kuldanek, Kristin, Thornhill, John, Muir, David, Bonnissent, Alice, Timson, Georgina, Frater, John
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5651802/
https://www.ncbi.nlm.nih.gov/pubmed/29057945
http://dx.doi.org/10.1038/s41598-017-13287-2
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author Fidler, Sarah
Lewis, Heather
Meyerowitz, Jodi
Kuldanek, Kristin
Thornhill, John
Muir, David
Bonnissent, Alice
Timson, Georgina
Frater, John
author_facet Fidler, Sarah
Lewis, Heather
Meyerowitz, Jodi
Kuldanek, Kristin
Thornhill, John
Muir, David
Bonnissent, Alice
Timson, Georgina
Frater, John
author_sort Fidler, Sarah
collection PubMed
description There is a global need for HIV viral load point-of-care (PoC) assays to monitor patients receiving antiretroviral therapy. UNICORN was the first study of an off-label protocol using whole blood finger-prick samples tested with and without a simple three minute spin using a clinic-room microcentrifuge. Two PoC assays were evaluated in 40 HIV-positive participants, 20 with detectable and 20 with undetectable plasma viral load (pVL) (<20 copies/ml). Using 100 µl finger-prick blood samples, the Cepheid Xpert HIV-1 Viral Load and HIV-1 Qual cartridges were compared with laboratory pVL assessment (TaqMan, Roche). For participants with undetectable viraemia by TaqMan, there was poor concordance without centrifugation with the TaqMan platform with only 40% ‘undetectable’ using Xpert VL and 25% ‘not detected’ using the Qual assay. After a 3 minute spin, 100% of samples were undetectable using either assay, showing full concordance with the TaqMan assay. Defining a lower limit of detection of 1000 copies/ml when including a spin, there was 100% concordance with the TaqMan platform with strong correlation (rho 0.95 and 0.94; p < 0.0001 for both assays). When including a simple microcentrifugation step, finger-prick PoC testing was a quick and accurate approach for assessing HIV viraemia, with excellent concordance with validated laboratory approaches.
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spelling pubmed-56518022017-10-26 A pilot evaluation of whole blood finger-prick sampling for point-of-care HIV viral load measurement: the UNICORN study Fidler, Sarah Lewis, Heather Meyerowitz, Jodi Kuldanek, Kristin Thornhill, John Muir, David Bonnissent, Alice Timson, Georgina Frater, John Sci Rep Article There is a global need for HIV viral load point-of-care (PoC) assays to monitor patients receiving antiretroviral therapy. UNICORN was the first study of an off-label protocol using whole blood finger-prick samples tested with and without a simple three minute spin using a clinic-room microcentrifuge. Two PoC assays were evaluated in 40 HIV-positive participants, 20 with detectable and 20 with undetectable plasma viral load (pVL) (<20 copies/ml). Using 100 µl finger-prick blood samples, the Cepheid Xpert HIV-1 Viral Load and HIV-1 Qual cartridges were compared with laboratory pVL assessment (TaqMan, Roche). For participants with undetectable viraemia by TaqMan, there was poor concordance without centrifugation with the TaqMan platform with only 40% ‘undetectable’ using Xpert VL and 25% ‘not detected’ using the Qual assay. After a 3 minute spin, 100% of samples were undetectable using either assay, showing full concordance with the TaqMan assay. Defining a lower limit of detection of 1000 copies/ml when including a spin, there was 100% concordance with the TaqMan platform with strong correlation (rho 0.95 and 0.94; p < 0.0001 for both assays). When including a simple microcentrifugation step, finger-prick PoC testing was a quick and accurate approach for assessing HIV viraemia, with excellent concordance with validated laboratory approaches. Nature Publishing Group UK 2017-10-20 /pmc/articles/PMC5651802/ /pubmed/29057945 http://dx.doi.org/10.1038/s41598-017-13287-2 Text en © The Author(s) 2017 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.
spellingShingle Article
Fidler, Sarah
Lewis, Heather
Meyerowitz, Jodi
Kuldanek, Kristin
Thornhill, John
Muir, David
Bonnissent, Alice
Timson, Georgina
Frater, John
A pilot evaluation of whole blood finger-prick sampling for point-of-care HIV viral load measurement: the UNICORN study
title A pilot evaluation of whole blood finger-prick sampling for point-of-care HIV viral load measurement: the UNICORN study
title_full A pilot evaluation of whole blood finger-prick sampling for point-of-care HIV viral load measurement: the UNICORN study
title_fullStr A pilot evaluation of whole blood finger-prick sampling for point-of-care HIV viral load measurement: the UNICORN study
title_full_unstemmed A pilot evaluation of whole blood finger-prick sampling for point-of-care HIV viral load measurement: the UNICORN study
title_short A pilot evaluation of whole blood finger-prick sampling for point-of-care HIV viral load measurement: the UNICORN study
title_sort pilot evaluation of whole blood finger-prick sampling for point-of-care hiv viral load measurement: the unicorn study
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5651802/
https://www.ncbi.nlm.nih.gov/pubmed/29057945
http://dx.doi.org/10.1038/s41598-017-13287-2
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