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Amplifying and Quantifying HIV-1 RNA in HIV Infected Individuals with Viral Loads Below the Limit of Detection by Standard Clinical Assays
Published on: September 26, 2011
Viral load testing in a resource-limited setting: quality control is critical
Jane Greig1, Philipp du Cros, Derryck Klarkowski
1Manson Unit, Médecins Sans Frontières, London, UK. jane.greig@london.msf.org
Journal of the International AIDS Society
|May 17, 2011
Summary
Routine viral load testing for HIV patients is recommended but challenging in resource-limited settings. Without rigorous quality control, inaccurate results can harm patient care and treatment outcomes.
Area of Science:
- Medical Diagnostics
- Public Health
- Virology
Background:
- World Health Organization recommends routine viral load testing for antiretroviral treatment (ART).
- Implementation in resource-limited settings is hindered by cost, availability, and complexity.
- Médecins Sans Frontières (MSF) faced challenges in a large HIV program in sub-Saharan Africa.
Purpose of the Study:
- To describe issues encountered by MSF during routine viral load testing implementation.
- To highlight the impact of laboratory challenges on patient management.
- To emphasize the need for quality assurance in viral load testing.
Main Methods:
- Viral load testing of over 1200 patients on ART between October 2005 and August 2006.
- Baseline and three-month interval testing performed by a local reference laboratory.
- Quality control measures and outcomes documented with a second laboratory.
Main Results:
- Only 53% of ART-naïve patients achieved viral loads <1000 copies/mL, lower than expected.
- Duplicate testing revealed unacceptable discordance, indicating reliability concerns.
- Laboratory issues included disregarded quality control, delays, and sample variations.
Conclusions:
- Viral load testing without robust quality control risks erroneous and harmful results.
- Reliable viral load testing requires stringent quality assurance protocols.
- A guide was developed to assess laboratory suitability for accurate viral load testing.
