Initiative Improves HIV Testing in African Children

Molecular kits that qualitatively test blood for human immunodeficiency virus (HIV) are being made available to African health care facilities.

In a joint initiative, the RealTime HIV-1 test, which is until now has only been used for research purposes, will be made available to sub-Saharan countries. In addition, the offer will include the capability to collect and process samples using dried blood spots (DBS). The use of DBS for specimen collection eliminates the need for refrigeration of specimens.

The RealTime HIV-1 Qualitative test is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for the quantitation of Human immunodeficiency virus 1 (HIV-1) on the automated m2000 System in human plasma from HIV-1 infected individuals over the range of 40 to 10,000,000 copies/mL. The RealTime HIV-1 assay is intended for use in conjunction with clinical presentation and other laboratory markers for disease prognosis and for use as an aid in assessing viral response to antiretroviral treatment as measured by changes in plasma HIV-1 RNA levels.

The test and system are provided by Abbott Laboratories, (Abbott Park, IL, USA), who are working in partnership with the Clinton Health Access Initiative (CHAI; New York, NY, USA). In addition to the supply of HIV tests and DBS sample collection for research use, Abbott is collaborating with CHAI to develop a "turn-key" laboratory solution, including training protocols on instruments that will be used to establish fully functioning molecular diagnostic laboratories in regions where such facilities do not currently exist. The test is expected to be Conformite Europeene (CE) marked by January 2011, which will certify that the product has met the health, safety, and environmental requirements of the European Union, thereby ensuring consumer and workplace safety. At this time, this assay is not intended to be used as a donor-screening test for HIV-1 or as a diagnostic test to confirm the presence of HIV-1 infection.

Stafford O'Kelly, head of Abbott's molecular diagnostics business, said, "We're pleased to be collaborating with the CHAI in its proactive outreach effort to test infants in developing nations for HIV. Accurate and accessible HIV testing, particularly for diagnosis of HIV/AIDS in infants less than 18 months of age, is essential for optimal management and treatment of the disease."

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