NHLS (Johannesburg, South Africa)
The National Health Laboratory Service (NHLS) is the largest diagnostic pathology service in South Africa and supports the national and provincial health departments in the delivery of healthcare. Over 80% of the population is served through the national network of NHLS Laboratories. Prof Wendy Stevens is the Director of the National Priority Programmes (NPP) within the NHLS. The NPP focuses on HIV, TB and HPV and aims to provide affordable, sustainable health laboratory services to support the clinical care for these diseases. iLEAD collaborates with the NHLS and more specifically the NPP to undertake relevant research and to understand the implementation science impacts of new innovations on large scale laboratory programs.
WITS (Johannesburg, South Africa)
The University of the Witwatersrand (Wits) is situated in Johannesburg, South Africa and in 2017 was the highest ranking University in Africa (in the 2017 Academic Ranking of World Universities). Wits placed 230th in the overall rankings. The Department of Molecular Medicine and Haematology (DMMH) within the Faculty of Health Sciences is a joint venture with the NHLS and addresses unique basic science and research aspects across Molecular Medicine and Haematology as well as providing clinical and diagnostic services to patients in South Africa. iLEAD is the newest off shoot of DMMH, and besides DMMH hosting the core office of iLEAD, it is also one of the three collaborating centers within the iLEAD Innovation Network.
IRESSEF (Dakar, Senegal)
Prof Mboup recently established non-profit laboratory organization, the Institut de Recherche en Santé, de Surveillance Epidémiologique et de Formation (IRESSEF) in the Diamniadio District near Dakar. IRESSEF is dedicated to biomedical research, training and networking across Senegal, the West African and sub-Saharan region. IRESSEF aims to continue providing support, policy guidance and recommendations to the Public Health Laboratories Network through the Directorate of Laboratories in the Ministry of Health in Senegal based in Dakar. Within the past 3 years, the Directorate is focused on services within a tiered laboratory infrastructure, responsible for regulation (reagents and tests), technical support and epidemiological surveillance across the public sector laboratories (80% coverage, through 140 laboratories). This is with input from the CDC and PATH to support the Global Health Security Agenda. IRESSEF is attached to 45 clinical sites for virology projects, and has extensive network collaborations and members with organizations and consortia across West Africa such as West African Global Health Access (WAGHA), West African Taskforce for the Control of Emerging and Re-emerging Infectious Diseases (WATER), West Africa Platform for HIV Intervention Research (WAPHIR) and West African Network for TB AIDS and Malaria (WANTAM). Other partners include several universities, local partners, pharmaceutical firms, foundations and organizations such as the WHO-UNAIDS, CDC, the European Commission, the European and Developing Countries Clinical Trials Partnership (EDCTP), German Agency for Technical Cooperation (GTZ), Wellcome Trust, GILEAD and, BMGF amongst others. The IRESSEF has laboratory capacity and infrastructure across diagnostic disciplines with established units of virology, bacteriology, immunology and molecular biology, as well as a biobank with state-of-the-art equipment for an effective management of samples for continued research.
IRESSEF emphasizes Quality Management Systems (QMS) and Good Laboratory Practice (GLP) components for their clinical diagnostic and research laboratories. They have implemented and standardized technical standard operating procedures (SOPs), laboratory management processes and biosafety procedures for critical laboratory assays. IRESEFF is enrolled in Proficiency Testing programs with the College of American Pathology (CAP), the United Kingdom National External Quality Assessment Program (UK-NEQAS), the Quality Assurance Systems International (QASI), and the National Institute of Health (NIH) Department of AIDS (DAIDS) Virology Quality Assurance program (VQA) and l’Agence nationale de recherches sur le sida et les hépatites virales (ANRS, France). This quality framework has enabled IRESEFF to further develop PT panels, manufacture and coordinate local laboratory proficiency testing (PT) programs via internal QA and EQA programs for HIV early infant diagnosis (EID) and HIV monitoring (CD4 and viral load) for many African countries and supports QMS strengthening, focusing on research training and quality improvement (RTQI). Through AFRIQUALAB, IRESSEF also supports more than 30 countries across Africa for Biochemistry, Hematology, Serology and TB EQA. Together with their clinical collaborators, IRESSEF ensures the rigorous requirements to support clinical trials in compliance with International Conference on Harmonization (ICH) guidelines; U.S. Federal regulations and ISO are in place. One such example in the HIV/AIDS biomedical research performed included natural history cohort studies on HIV-1 and HIV-2. These cohort studies led to the discovery of HIV-2 infection by the IRESSEF team which, together with Harvard University, which evolved as one of the strongest HIV-2 research groups in the world.
INS (Maputo, Mozambique)
The Instituto Nacional de Saúde (INS) in Maputo is responsible for directorship of scientific affairs and business administration, and has five departments: Laboratory Technology, Surveillance, Laboratory Network and Reference Services, Training and Communications, and Research. The Laboratory Technology Department comprises the divisions of molecular virology, virus isolation, cellular immunology, serology, parasitology, bacteriology and entomology. All divisions have a Quality Management System (QMS) in place and participate in local and international proficiency testing (PT) schemes such as QASI, CDC, Thistle and NHLS, which encompasses bacteriology, Cryptococcus, DNA PCR, Gram stain, GeneXpert MTB/RIF, HBV, HCV, HIV serology, Malaria microscopy and serology, Syphilis serology, tuberculosis smear microscopy and CD4 counting. Each division provides routine standard of care testing in the public sector to the Ministry of Health. The Surveillance Department is responsible for statistical analysis, data management and outbreak monitoring and a strategic group focused on epidemiology training, surveillance in high-risk groups, and population surveillance. The Training and Communications Department is responsible for technical training and certification in the laboratory environment, career development and capacity building as well as sustaining the National Health Library. The Laboratory Network and Reference Service provides PT scheme material and programs, monitors laboratory quality and performance through site visits and, provide technical assistance GCP and GCLP trainings for lab technicians from reference labs under the INS. The Department of Research manages clinical trials, performs operational research, and executes laboratory/technology evaluations.
The national priority diseases in Mozambique are HIV, TB and Malaria, with increasing concern around sexually transmitted diseases, emerging/re-emerging diseases and NCD. The Director General’s position includes direct engagement and involvement with the Institutional Bioethics, Biosafety and Quality Committees as well as a direct link to the research centers involved in clinical trials (responsible specifically for HIV and TB), operational research and surveillance in surrounding provinces. Overall the Mozambique Ministry of Health is responsible for the INS clinical diagnostic laboratories as well as the Medical Services (including the lab network and point of care testing sites). These clinical diagnostic laboratories are within a tiered system: ten reference laboratories (level 5), three central hospital laboratories (level 4), eight provincial laboratories (level 3), 56 general and rural laboratories (level 2) and 277 health center laboratories (level 1). In total these comprise RDT HIV and malaria sites as well as six EID HIV PCR laboratories, one HIV drug resistance profiling laboratory, 45 CD4 testing laboratories (servicing 166 sites) and three TB reference laboratories.
Areas of strength within the INS laboratory service are qualified human resources that support all levels of the laboratory network, a broad infrastructure to manage relevant clinical and laboratory trials and evaluations, as well as technical support through ongoing site visits, EQA and accreditation implementation. SLMTA and SLIPTA programs are in place in all provinces of Mozambique, with provincial mentors from the MoH holding responsibility to implement the programs across level 2 to level 4 laboratories. The INS TB reference and cellular immunology laboratories have techniques accredited by the Instituto Português para Acreditação (IPAC). Connectivity is growing; with an LIS linking all reference laboratories to provincial and central hospital laboratories and SMS printers available to receive EID and GeneXpert MTB/RIF results in certain remote areas. Dashboards for POC-CD4 errors and EID and VL turn-around time management are available. Across the laboratory, clinical, bioethics and statistics functions; the group is responsible for contributing to guideline documents, conference and meeting presentations and publications. Partners of the group include CDC Mozambique, Global Fund to Fight AIDS, Tuberculosis and Malaria, CHAI, UNITAD, ASLM, American Society for Clinical Pathology (ASCP), Association of Public Health Laboratories (APHL), Friends in Global Health (FGH), Family Health International (FHI) 360, Human Appeal International (HAI) and WHO amongst others.