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BioMed Research International
Volume 2014, Article ID 102598, 10 pages
http://dx.doi.org/10.1155/2014/102598
Research Article

Performance and Logistical Challenges of Alternative HIV-1 Virological Monitoring Options in a Clinical Setting of Harare, Zimbabwe

1Amsterdam Institute for Global Health and Development (AIGHD), Department of Global Health, Academic Medical Center, P.O. Box 22700, 1100 DE Amsterdam, The Netherlands
2Newlands Clinic, 56 Enterprise Road, Newlands, Harare, Zimbabwe
3Department of Molecular Medicine and Haematology, University of the Witwatersrand 7 York Road, Parktown, Johannesburg 2193, South Africa

Received 31 January 2014; Revised 25 April 2014; Accepted 18 May 2014; Published 15 June 2014

Academic Editor: Antonio Pacheco

Copyright © 2014 Pascale Ondoa et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

We evaluated a low-cost virological failure assay (VFA) on plasma and dried blood spot (DBS) specimens from HIV-1 infected patients attending an HIV clinic in Harare. The results were compared to the performance of the ultrasensitive heat-denatured p24 assay (p24). The COBAS AmpliPrep/COBAS TaqMan HIV-1 test, version 2.0, served as the gold standard. Using a cutoff of 5,000 copies/mL, the plasma VFA had a sensitivity of 94.5% and specificity of 92.7% and was largely superior to the VFA on DBS (sensitivity = 61.9%; specificity = 99.0%) or to the p24 (sensitivity = 54.3%; specificity = 82.3%) when tested on 302 HIV treated and untreated patients. However, among the 202 long-term ART-exposed patients, the sensitivity of the VFA decreased to 72.7% and to 35.7% using a threshold of 5,000 and 1,000 RNA copies/mL, respectively. We show that the VFA (either on plasma or on DBS) and the p24 are not reliable to monitor long-term treated, HIV-1 infected patients. Moreover, achieving acceptable assay sensitivity using DBS proved technically difficult in a less-experienced laboratory. Importantly, the high level of virological suppression (93%) indicated that quality care focused on treatment adherence limits virological failure even when PCR-based viral load monitoring is not available.