MICA: Performance evaluation of a point-of-care whole blood viral load test (SAMBA) to optimize HIV treatment in resource-limited settings

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As of 2012, 9.7 million individuals were receiving antiretroviral therapy (ART) for treatment of HIV-1 infection in low- and middle-income countries. However, among patients receiving first-line ART, 20-30% will have a detectable viral load after 12 months. The long-term success of ART programmes is heavily dependent on accurate, available and timely viral load monitoring to document viral suppression or indicate the need for second line ART switch. Existing HIV viral load assays require significant infrastructure and highly trained personnel to perform, thus only a few centralised laboratories are capable of viral load testing in most developing countries. Centralised testing leads to poor access to those in need, long turn-around times, delay of results and subsequent loss of patients, all of which lead to sub-optimal ART treatment outcomes, which can cause significant morbidity and mortality.The University of Cambridge, in partnership with Diagnostics for the Real World, has developed an innovative point-of-care nucleic acid amplification test for the diagnosis monitoring the efficacy of HIV treatment by determining of the amount of circulating virus is above or below the threshold for treatment failure. The SAMBA HIV-1 Semi-Q Test allows the patient to be tested and treated in the same visit, thus improving access and treatment outcomes. The plasma-based semi-automated (SAMBA I) assay has received product approval in Malawi, Kenya, Zimbabwe and Uganda and has been used for testing of over 35,500 patients at Médecins sans Frontières (MSF) sites in Malawi and Uganda to date. The SAMBA HIV-1 Semi-Q Test has recently been improved to enable the use of small volume whole blood, using a patented method of filtration. This removes the need for plasma separation, thus increasing utility at lower cadre health clinics and reduces the time to result. In addition a fully automated SAMBA instrument system has been developed, called SAMBA II. The key aims of this proposal are: 1) integrate the whole blood SAMBA HIV-1 Semi-Q Test onto the fully automated SAMBA II instrument, 2) perform an evaluation in house, in Africa and in Europe to evaluate its perforce compared to another CE-marked test and 3) submit for CE-mark. Although the SAMBA test will most likely be used in Africa, a CE-mark is required to allow it to be procured by NGO's.