Evaluation of a point-of-care whole blood viral load test for HIV
Research type
Research Study
Full title
Comparing a new Point-of-Care whole blood viral load test (SAMBA II HIV-1 Whole Blood SemiQ) to a Gold Standard test in HIV positive patients in the UK, Ukraine and Africa
IRAS ID
202570
Contact name
Sarah Oakley-Mudge
Contact email
Sponsor organisation
Diagnostics for the Real World (Europe) Ltd
ISRCTN Number
ISRCTN12803987
Duration of Study in the UK
0 years, 7 months, 2 days
Research summary
In 2014 an estimated 36.9 million people were living with HIV. Effective antiretroviral therapy (ART) improves the survival of HIV-infected individuals and prevents transmission. Routine monitoring of HIV-infected individuals on ART using viral load (VL) testing is necessary to identify treatment failure. Current HIV VL tests are limited to centralised laboratories, as they require high infrastructure and trained personnel. HIV patients living outside of major cities in developing countries often do not have access to VL testing. Even when VL testing is available, there are often delays in obtaining test results or loss of samples during shipment, leading to high loss to follow-up. Point-of-care (POC) VL testing in lower healthcare facilities may overcome these limitations, improving patient outcomes.
The Diagnostics Development Unit, University of Cambridge (DDU), have developed an innovative POC test (SAMBA II HIV-1 Whole Blood Semi-Q) for the diagnosis of ART failure in resource-limited settings. This test uses a small volume of whole blood (WB) that can be easily collected by finger prick.
The aim of this project is to validate the SAMBA II HIV-1 Whole Blood Semi-Q and perform clinical evaluation required for CE-marking of the test. CE-marking requires testing in the UK and is a requirement for procurement of diagnostics into the developing world. We will also perform clinical trials in Africa and Ukraine, where the test will most likely be used.
The study will aim to recruit 2,300 HIV-positive patients, over 9 months, across four study sites based in 4 countries (United Kingdom, Ukraine, Cameroon and Uganda). Patients attending clinic for routine monitoring will be invited to donate an extra blood sample that will be tested using SAMBA II HIV-1 Whole Blood Semi-Q.
We will compare the accuracy of the SAMBA II HIV-1 Whole Blood Semi-Q compared to the current Gold Standard HIV VL tests.
REC name
East of England - Essex Research Ethics Committee
REC reference
16/EE/0409
Date of REC Opinion
26 Jan 2017
REC opinion
Further Information Favourable Opinion