Prof. Stevens qualified as a medical doctor from the University of the Witwatersrand in Johannesburg, South Africa, with cum laude in 1989 and pursued a career in laboratory Medicine. She received a best pathology registrar award in 1995 and a distinction for a degree during her specialization in haematology which she completed in 1995. She rose very quickly through the ranks and was appointed first as acting Head of the Department of Molecular Medicine and Haematology and full professor and Head in 2003. In this regard she now holds a joint position with the National Health Laboratory Service (largest pathology service provider in South Africa that services 80% of the population in the public sector) and the University of the Witwatersrand. As a haematologist her initial focus was working in the field of leukaemia and lymphoma using the flow cytometry and molecular PCR testing platforms, but soon realised as the HIV epidemic in South Africa exploded there was urgent need to apply these testing platforms and skill to laboratory tests for HIV infected individuals and on an a massive and sustainable scale [1-2].

Within a few years Prof. Stevens created a team that established the first HIV PCR laboratory in the NHLS to provide public service testing for early HIV infant diagnosis [3-10], CD4 counting [11-15] and HIV viral load testing [16-25], all based on strong scientific research and development. Now twenty years later her efforts in laboratory development and expansion supports 360,000 EID assays (11 laboratories), 1.6 million viral load assays (17 laboratories) and 4 million CD4 test (62 laboratories) annually in South Africa (NHLS, Central Data Warehouse). A large part of the success of her programme has been in developing a strong research and development team that have worked with a mission of ensuring access to affordable, appropriate diagnostics in the HIV field. For many of these assays much operational research and advocacy was required to move from concept to implementation. A classic example was HIV viral load testing which for many years considered by many groups to expensive to implement. A great deal of evaluation of different assay formats and algorithms by Prof. Stevens’ team resulted in the inclusion of viral load testing in the South African National HIV Treatment Guidelines and this laboratory was one of the first routinely implementing the test. The result of this is that transmitted HIV drug resistance may be lower in South Africa than other countries in the region [26]. Resistance testing was the next logical step and a facility was established by Prof. Stevens to conduct sequencing for drug resistance for patient care (difficult cases), but also to facilitate research in the field [14, 27-33]. Numerous publications have emanated from this effort which has assisted with designing treatment regimens and understanding resistance [26, 34-45]. There will be further expansion in 2012 for drug resistance testing through a grant awarded to Prof. Stevens through The Global Fund. Much effort has been put into investigating more affordable resistance testing approaches such as ultra-light test sequencing only RT region, using ultra-deep sequencing and pooling samples with tags that could potentially save enormous costs. Prof. Stevens is currently assisting with the establishment of a National Drug Resistance Task Team to address not only annual surveillance but surveillance of resistance at several sentinel sites throughout the country and of course the development of a database that is accessible for policy-making.

In 2010 Prof. Stevens saw the need to not only continue strengthening the HIV centralised laboratory programme, but to integrate within this a national laboratory programme for rapid diagnostic testing for tuberculosis (TB) [46]. For years HIV and TB laboratory testing and patient treatment programmes were managed in silos, but ~80% TB infected patients are HIV positive in South Africa. Prof. Stevens formed the National Priority Programme (NPP) within the NHLS, drawing largely from her HIV laboratory and R&D team to implement the new WHO-endorsed TB diagnostic test, Xpert MTB/RIF (Cepheid) test[47-52]. She developed a national implementation plan [53, 54] and within a very short time succeeded in securing 350 million ZAR from international funding bodies such as CDC, The Global Fund and the National Department of Health. By March 2011 the NPP team had implemented one testing facility in each of the nine provinces in South Africa, and by May 2012 (1 year later) >500,000 Xpert TB tests had been performed in now 64 centres, making this programme the leading global programme for molecular implementation of gene Xpert testing. As a result of Prof. Stevens’ programme, twice as many TB infected patients (16% vs. 8%); compared to previous testing strategies in centres of implementation have been diagnosed in South Africa. Prof. Stevens has also recently created a multidisciplinary team to focus on extending both HIV and TB testing laboratory models to investigate the potential for providing such testing at point-of-care (POC) directly in primary health care clinics [52, 55-57]. This latter operational research initiative is being funded through a Grand Challenges Canada grant awarded to Prof. Stevens. Recent realisation by Prof. Stevens has been the work that needs to be done to ensure cost-effectiveness of diagnostic implementation and to measure the impact of such interventions for which a new team has been established [53-54, 58-59].

Over and above improving laboratory medicine in South Africa through the NHLS, Prof. Stevens has been a strong supporter of laboratory upliftment across Africa and has developed training courses for Good Laboratory Practice (GLP), Good Clinical Laboratory Practice [60], CD4, and viral load that have reached at least 947 people in 60 different centres outside of South Africa (see attached list). She has transferred her programmes and experience to the development of laboratories in countries such as Kenya, Rwanda, Tanzania and Uganda to name a few. In South Africa Prof. Stevens runs a department that teaches technologists, scientists and registrars in both the pathology discipline of Haematology and in Molecular Medicine. Over the years, this department has taken both scientists, technologists and registrars as supernumery staff and once their training is complete sent them back to their respective countries. Students have come from Libya, Namibia, Rwanda, Sudan, Tanzania, Uganda and Zambia to name a few. On average the output of publications for the group is in the region of 60-70 per year. Several EQA programmes have been developed and supported by Prof. Stevens and her group; the CD4 programme has been distributed to over 500 laboratories in Africa, as an example [13].

None of these activities would have happened without the ability to solicit donor funds. To ensure the sustainability of this process, Prof. Stevens was one of the four founding members of the Wits Health Consortium, Pty Ltd (www.witshealth.co.za) which has now managed several billions of donor funds over the years for the faculty of Health Sciences at the University of the Witwatersrand, mostly supporting HIV-related research. Prof. Stevens has in her personal capacity raised over 400,000,000 ZAR to support many of her projects and research. Donors have included the US National Institutes of Health (NIH) (through networks such as the AIDs Clinical Trial Group, HIV Vaccine trial network, paediatric network and CHAVI). Newer projects with respective funders such as the Gates Foundation (GeneXpert impact study, XTEND and more recently Grand Challenges Canada for evaluation of Point-of-Care for HIV and TB in various HIV clinics), the US Centers for Disease Control and Prevention (largely, for GeneXpert project), The Global Fund (for both HIV drug resistance testing, expansion of resistance capacity.) In addition to involvement in purely operational research for laboratories, Prof. Stevens has been very active in very large clinical studies that have changed policy in South Africa and other countries (see attached list and CV). A classic example would be the CIPRA study whose two important outputs were: Nurse-based ARV initiation was not inferior to doctor-based initiation of ARV [61] and the second one, the CHER study, which forced national policy to change paediatric treatment guidelines. Prof. Stevens has noted that when clinical trial laboratories were set up, the knock-on effect was to raise the standards in laboratories within that region [62].

During this career, Prof. Stevens has shared her experience and worked on various working groups within the World Health Organization such as in HIV diagnostics forums, viral load, CD4, EID and drug resistance workshops. In addition, she has been an advisor to PEPFAR, CDC, the Clinton Foundation and Gates Foundation for many years, for many aspects of her work. More recently workshops held by the NIH on point-of care and TB and HIV were also attended by Prof. Stevens. She currently supports many of these organisations as a reviewer of potential projects and thus sits on several international Peer Review Committees (e.g. UNITAID PRC (2010-current), Gates Foundation (2012), CIFF, etc).

The ideals of laboratory strengthening and the elevation of the importance of the laboratory contribution in healthcare within Africa has been the goal of Prof. Stevens and her lifetime of work is finally being realised with organisations internationally, such as the development of the African Society for Laboratory Medicine (ASLM), and locally in South Africa through the development of programmes such as the National Priority Programme. Prof. Stevens serves as a board member for ASLM.

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