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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Development and evaluation of an affordable real-time qualitative assay for determining HIV-1 virological failure in plasma and dried blood spots
Journal of Clinical Microbiology, Volume 51, No. 6, Year 2013
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Description
Virological failure (VF) has been identified as the earliest, most predictive determinant of HIV-1 antiretroviral treatment (ART) failure. Due to the high cost and complexity of virological monitoring, VF assays are rarely performed in resource-limited settings (RLS). Rather, ART failure is determined by clinical monitoring and to a large extent immunological monitoring. This paper describes the development and evaluation of a low-cost, dried blood spot (DBS)-compatible qualitative assay to determine VF, in accordance with current WHO guideline recommendations for therapy switching in RLS. The assay described here is an internally controlled qualitative real-time PCR targeting the conserved long terminal repeat domain of HIV-1. This assay was applied to HIV-1 subtypes A to H and further evaluated on HIV-1 clinical plasma samples from South Africa (n = 191) and Tanzania (n = 42). Field evaluation was performed in Uganda using local clinical plasma samples (n = 176). Furthermore, assay performance was evaluated for DBS. This assay is able to identify VF for all major HIV-1 group M subtypes with equal specificity and has a lower detection limit of 1.00E+03 copies/ml for plasma samples and 5.00E+03 copies/ml for DBS. Comparative testing yielded accurate VF determination for therapy switching in 89% to 96% of samples compared to gold standards. The assay is robust and flexible, allowing for "open platform" applications and producing results comparable to those of commercial assays. Assay design enables application in laboratories that can accommodate real-time PCR equipment, allowing decentralization of testing to some extent. Compatibility with DBS extends access of sampling and thus access to this test to remote settings. Copyright © 2013, American Society for Microbiology. All Rights Reserved.
Authors & Co-Authors
Aitken, Susan C.
Netherlands, Utrecht
University Medical Center Utrecht
Kliphuis, Aletta
Netherlands, Amsterdam
Pharmaccess International
Bronze, Michelle
South Africa, Johannesburg
University of the Witwatersrand
Wallis, Carole Lorraine
South Africa, Johannesburg
Lancet Laboratories
Kityo, Cissy Mutuluuza
Uganda, Kampala
Joint Clinical Research Center Uganda
Balinda, Sheila N.
Uganda, Kampala
Joint Clinical Research Center Uganda
Stevens, Wendy Susan
South Africa, Johannesburg
University of the Witwatersrand
South Africa, Johannesburg
National Health Laboratory Service
Spieker, Nicole
Netherlands, Amsterdam
Pharmaccess International
De Oliveira, Tulio
South Africa, Durban
University of Kwazulu-natal
Rinke de Wit, Tobias Floris
Netherlands, Amsterdam
Pharmaccess International
Netherlands, Amsterdam
Amsterdam Institute for Global Health and Development
Schuurman, Rob J.
Netherlands, Utrecht
University Medical Center Utrecht
Statistics
Citations: 13
Authors: 11
Affiliations: 8
Identifiers
Doi:
10.1128/JCM.03305-12
ISSN:
00951137
e-ISSN:
1098660X
Research Areas
Health System And Policy
Infectious Diseases
Study Approach
Qualitative
Study Locations
South Africa
Tanzania
Uganda