The evaluation of the Alere system and viral load assay was investigator-initiated, and the Mozambican group purchased all platforms and tests used in the evaluation. "Against this background, point-of-care assays for viral load could provide same-day results to patients and clinicians, even in hard-to-reach areas of the country, same-day results for critical tests have been shown to increase efficiency of medical care and to have positive impact on patient-important outcomes." And the implementation of classical, laboratory-based testing in the country has been faced with many delays, mainly due to weaknesses in the health system, Jani said. But only a small proportion of patients in Mozambique currently have access to it. Viral load testing is considered an important component of quality HIV care and is used to monitor response to anti-retroviral treatment (ART). "Most of these people live in poverty and in settings where access to a health facility is problematic, the health system is faced with many challenges and struggles to provide quality care, including laboratory testing, to patients." More than 1 million of Mozambique's 25 million inhabitants are infected with HIV, Jani said in an email. Jani explained that the evaluation, which was conducted in collaboration with the Clinton Health Access Initiative, was motivated by the urgent need the country is facing for point-of-care viral load monitoring. Ilesh Jani, director general of Mozambique's National Institute of Health, co-authored the JCM study as well as a previous evaluation of the Alere q HIV-1/2 Detect which showed that test was comparable to lab-based testing for early infant HIV diagnosis. However, the evaluated assay "is not the HIV1/2 Whole Blood assay that we will bring to commercialization," the Alere spokesperson stressed. The company is also developing a quantitative test for whole blood, a prototype of which was evaluated in the Mozambican study published this month in the Journal of Clinical Microbiology. The study was based on an early prototype of the test and Alere has already made significant additional developments, a spokesperson at Alere emphasized in an email to GenomeWeb.Īlere has been developing both qualitative and quantitative HIV tests on its Alere q platform, which is designed to enable rapid testing in low-resource settings, as previously reported.Ī qualitative assay, called the Alere q HIV-1/2 Detect, received CE marking in 2015. NEW YORK (GenomeWeb) – A research group in Maputo, Mozambique has evaluated a prototype HIV viral load assay from Alere and shown that, while point-of-care testing is tantalizingly feasible, the particular assay is not yet ready for clinical use.
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