Using Exclusion-Based Sample Preparation (ESP) to Reduce Viral Load Assay Cost

Scott M. Berry; Hannah M. Pezzi; Eram D. Williams; Jennifer M. Loeb; David J. Guckenberger; Alex J. LaVanway; Alice A. Puchalski; Cissy M. Kityo; Peter N. Mugyenyi; Franklin M. Graziano; David J. Beebe

doi:10.1371/journal.pone.0143631

Using Exclusion-Based Sample Preparation (ESP) to Reduce Viral Load Assay Cost

Scott M. Berry
, Hannah M. Pezzi
, Eram D. Williams
, Jennifer M. Loeb
, David J. Guckenberger
, Alex J. LaVanway
, Alice A. Puchalski
, Cissy M. Kityo
, Peter N. Mugyenyi
, Franklin M. Graziano
, David J. Beebe

Research output: Contribution to journal › Article › peer-review

9 Scopus citations

Abstract

Viral load (VL) measurements are critical to the proper management of HIV in developing countries. However, access to VL assays is limited by the high cost and complexity of existing assays. While there is a need for low cost VL assays, performance must not be compromised. Thus, new assays must be validated on metrics of limit of detection (LOD), accuracy, and dynamic range. Patient plasma samples from the Joint Clinical Research Centre in Uganda were de-identified and measured using both an existing VL assay (Abbott RealTime HIV-1) and our assay, which combines low cost reagents with a simplified method of RNA isolation termed Exclusion-Based Sample Preparation (ESP).71 patient samples with VLs ranging from <40 to >3,000,000 copies/mL were used to compare the two methods. We demonstrated equivalent LOD (~50 copies/mL) and high accuracy (average difference between methods of 0.08 log, R² = 0.97). Using expenditures from this trial, we estimate that the cost of the reagents and consumables for this assay to be approximately $5 USD. As cost is a significant barrier to implementation of VL testing, we anticipate that our assay will enhance access to this critical monitoring test in developing countries.

Original language	English
Article number	e0143631
Journal	PLoS ONE
Volume	10
Issue number	12
DOIs	https://doi.org/10.1371/journal.pone.0143631
State	Published - Dec 1 2015

Bibliographical note

Publisher Copyright:
© 2015 Berryet al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Funding

Support for this study was provided by the Bill and Melinda Gates Foundation (www. gatesfoundation.org) Global Health Grant Number OPP1028788. SB, HP, JL, DG, AL, AP, and DB received materials and salary support from this grant. EW, CK, PM, and FG received materials support from this grant. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The authors would like to thank Dr. Elaine Alarid for providing the cell line used to produce the internal control RNA.

Funders	Funder number
Bill and Melinda Gates Foundation
Center for Global Health	OPP1028788
Center for Global Health

ASJC Scopus subject areas

General

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Cite this

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title = "Using Exclusion-Based Sample Preparation (ESP) to Reduce Viral Load Assay Cost",

abstract = "Viral load (VL) measurements are critical to the proper management of HIV in developing countries. However, access to VL assays is limited by the high cost and complexity of existing assays. While there is a need for low cost VL assays, performance must not be compromised. Thus, new assays must be validated on metrics of limit of detection (LOD), accuracy, and dynamic range. Patient plasma samples from the Joint Clinical Research Centre in Uganda were de-identified and measured using both an existing VL assay (Abbott RealTime HIV-1) and our assay, which combines low cost reagents with a simplified method of RNA isolation termed Exclusion-Based Sample Preparation (ESP).71 patient samples with VLs ranging from <40 to >3,000,000 copies/mL were used to compare the two methods. We demonstrated equivalent LOD (\textasciitilde{}50 copies/mL) and high accuracy (average difference between methods of 0.08 log, R2 = 0.97). Using expenditures from this trial, we estimate that the cost of the reagents and consumables for this assay to be approximately \$5 USD. As cost is a significant barrier to implementation of VL testing, we anticipate that our assay will enhance access to this critical monitoring test in developing countries.",

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N2 - Viral load (VL) measurements are critical to the proper management of HIV in developing countries. However, access to VL assays is limited by the high cost and complexity of existing assays. While there is a need for low cost VL assays, performance must not be compromised. Thus, new assays must be validated on metrics of limit of detection (LOD), accuracy, and dynamic range. Patient plasma samples from the Joint Clinical Research Centre in Uganda were de-identified and measured using both an existing VL assay (Abbott RealTime HIV-1) and our assay, which combines low cost reagents with a simplified method of RNA isolation termed Exclusion-Based Sample Preparation (ESP).71 patient samples with VLs ranging from <40 to >3,000,000 copies/mL were used to compare the two methods. We demonstrated equivalent LOD (~50 copies/mL) and high accuracy (average difference between methods of 0.08 log, R2 = 0.97). Using expenditures from this trial, we estimate that the cost of the reagents and consumables for this assay to be approximately $5 USD. As cost is a significant barrier to implementation of VL testing, we anticipate that our assay will enhance access to this critical monitoring test in developing countries.

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Using Exclusion-Based Sample Preparation (ESP) to Reduce Viral Load Assay Cost

Abstract

Bibliographical note

Funding

ASJC Scopus subject areas

UN SDGs

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