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Journal Article
|Research

Viral load testing in a resource-limited setting: quality control is critical

Greig J, du Cros PAK, Klarkowski DB, Mills C, Jorgensen S, Harrigan PR, O'Brien DP
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Abstract
BACKGROUND
World Health Organization guidelines now recommend routine use of viral load testing, where available, for patients receiving antiretroviral treatment (ART). However, its use has not been routinely implemented in many resource-limited settings due to cost, availability and accessibility. Viral load testing is complex, making its application in resource-limited settings challenging. We describe the issues encountered by Médecins Sans Frontières (MSF) when using routine viral load testing in a large HIV programme in sub-Saharan Africa.

METHODS
Between October 2005 and August 2006, more than 1200 patients on ART had viral load tests at baseline and at three-month intervals performed by a local reference laboratory that was quality assured by an experienced international institution. Concerns with reliability of results halted testing. The quality control measures instituted with a second laboratory and outcomes of these were documented.

RESULTS
In 2005 and 2006, only 178 of 334 (53%) previously ART-naïve patients tested after six to 12 months of treatment had viral loads of less than 1000 copies/mL. Similar MSF programmes elsewhere demonstrated virological suppression rates of more than 85%, and duplicate testing showed unacceptable discordance. Laboratory problems encountered included: disregarded quality control; time delays; requirement for retesting; and duplicate sample variations. Potentially harmful clinical outcomes of inaccurate viral load results include: unnecessary ART regimen changes; unnecessary enhanced adherence counselling after "false failures"; and undetected virological failure.

CONCLUSIONS
Viral load testing performed without rigorous quality control carries the risk of erroneous and potentially damaging results. Viral load testing should be utilized only if robust quality assurance has been implemented. Our experience in this and other settings led to the development of a guide for assessing the suitability of a laboratory for viral load testing that can be used to help achieve reliable results.

Countries

none

Subject Area

diagnostics

Languages

English
DOI
10.1186/1758-2652-14-23
Published Date
12 May 2011
PubMed ID
21569393
Journal
Journal of the International AIDS Society
Volume | Issue | Pages
Volume 14, Issue 1, Pages 23
Issue Date
2011-01-01
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Viral load testing in a resource-limited setting: quality control is critical | Journal Article / Research | MSF Science Portal