Low-Cost Tools for Diagnosing and Monitoring HIV Infection in Low-Resource settings/Outils a Faible Cout Pour le Diagnostic et le Suivi De L'infection Par le VIH Dans Des Contextes De Ressources limitees/Las Herramientas De Bajo Coste Para El Diagnostico Y Seguimiento De la Infeccion Por VIH En Entornos Con Pocos Recursos

By Wu, Grace; Zamana, Muhammad H. | Bulletin of the World Health Organization, December 2012 | Go to article overview

Low-Cost Tools for Diagnosing and Monitoring HIV Infection in Low-Resource settings/Outils a Faible Cout Pour le Diagnostic et le Suivi De L'infection Par le VIH Dans Des Contextes De Ressources limitees/Las Herramientas De Bajo Coste Para El Diagnostico Y Seguimiento De la Infeccion Por VIH En Entornos Con Pocos Recursos


Wu, Grace, Zamana, Muhammad H., Bulletin of the World Health Organization


Introduction

New technologies and drugs for early diagnosis, continuous monitoring and treatment of human immunodeficiency virus (HIV) infection have improved the prognosis of infection and the quality of life among individuals living with HIV. In 2009, five years after the availability of antiretroviral therapy (ART) was expanded in sub-Saharan Africa, drug treatments alone reduced mortality due to HIV infection and acquired immunodeficiency syndrome by 20%. (1) However, in the same year only one third of the 15 million people in low- and middle-income countries who were in need of ART received it. In these areas, a lack of resources, be they infrastructural, financial or human, hampers access to care for the resident populace. This results in delayed treatment, poor patient follow-up and poor adherence to ART, all of which contribute to the high rate of transmission and mortality. (2) Therefore, substantial efforts have been taken to build low-cost and reliable point-of-care (POC) HIV diagnostic and monitoring solutions that effectively make early diagnosis and treatments available to even the most resource-constrained communities.

Current gold standards

Several gold standard technologies with high sensitivity and specificity are used worldwide to efficiently diagnose and monitor HIV infection. Enzyme-linked immunosorbent assays (ELISAs) and simple/rapid tests are performed to diagnose HIV infection on the basis of HIV antibody detection. Flow cytometry is used to monitor CD4+ T-cell count and thereby determine when to initiate ART. The more expensive nucleic acid tests, such as polymerase chain reaction (PCR) assays, are used to detect virologic failure by monitoring the HIV load. PCR of dried blood spots is also the most effective technology for early diagnosis of HIV infection in infants (also known as "early infant diagnosis"), since assays based on antibody detection are unsuitable because maternal anti-HIV antibodies can persist in infant blood for up to 18 months after birth. PCR using dried blood spots is also useful for diagnosing HIV infection when cold-chain transport of liquid plasma samples is too costly or logistically complicated. (3,4)

These technologies are useful in a broad spectrum of resource-limited settings but they have disadvantages. With the exception of rapid tests, the technologies are costly, take hours to perform and require highly skilled technicians and dedicated laboratory spaces. As a result, many developing countries are unable to meet the demand for HIV infection diagnosis and monitoring. Zambia, for instance, has one of the highest incidences of HIV infection in the world but only dedicates three PCR machines to the diagnosis of infection in infants. Furthermore, although clinical symptoms and CD4+ T-cell count have been used in resource-limited settings to determine when to initiate therapy and when virologic failure has occurred, there is growing support to consider the results of viral load monitoring before making therapeutic decisions. The high cost of nucleic acid tests, coupled with logistical challenges involved with cold-chain transport, will probably force many clinics to refer patients to larger clinics for further testing, which could make patient follow-up difficult and delay initiation of treatment.

On the basis of these considerations, it is not surprising that in some locations little or no overlap exists between the set of HIV-associated health-care technologies that meet a specific need and the set of technologies that are practical and affordable. Therefore, a more ideal suite of technologies for use at the point of care is called for, especially in resource-limited settings.

Ideal point-of-care tests

The ASSURED (affordable, sensitive, specific, user-friendly, rapid and robust, equipment-free and deliverable to end users) criteria, outlined by the World Health Organization (WHO), provide a good framework for evaluating POC devices for resource-limited environments. …

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Low-Cost Tools for Diagnosing and Monitoring HIV Infection in Low-Resource settings/Outils a Faible Cout Pour le Diagnostic et le Suivi De L'infection Par le VIH Dans Des Contextes De Ressources limitees/Las Herramientas De Bajo Coste Para El Diagnostico Y Seguimiento De la Infeccion Por VIH En Entornos Con Pocos Recursos
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