Clinical Laboratory Services (CLS)
Chief executive: Dr. Ute Jentsch
The Clinical Laboratory Services (CLS), is a division of the Wits Health Consortium (WHC) of the School of Pathology. CLS’s main purpose is to support the teaching and research activities of the School of Pathology through the provision of laboratory services, diagnostic and research advice and data management support in accordance with the standards of Good Clinical Laboratory Practice (GCLP).
CLS is an accredited laboratory and has a comprehensive quality management plan to ensure adherence to GCLP and its accreditation standards ensuring integrity of clinical laboratory for clinical trial study participant care. CLS has achieved on-going certifications for SANAS (South African National Accreditation System) ISO 15189 and GCLP Accreditation through the British Qualogy Group, and is also inspected by Division of AIDS (DAIDS) annually.
Laboratory Support for Clinical Trials
The maintenance of participant confidentiality is paramount and study participants are not identified by name but rather by the use of unique identifiers. Prior to study initiation and laboratory testing, approval is obtained from the relevant ethics review committee and the institutional review boards. All clinical trial samples are processed, tested and stored in accordance with GCLP and sponsor guidelines.
All CLS departments receive on-going support from the NHLS speciality laboratories for specialized testing required by clinical trials. The Department of Molecular Medicine and Haematology has provided on-going support for HIV and HPV PCR testing, HIV Genotyping and CD4 testing. This testing is being conducted in the DAIDS certified HIV and Molecular Laboratory headed up by Dr. Carmona and Professor Glencross.
The organisation has provided laboratory services to over 70 NIH-funded clinical trials, as well as 265 other research projects primarily focused on HIV, TB and HIV/TB co-infection.
CLS enjoys collaborative relationships with the following organizations:
- Adult AIDS Clinical Trials Group (ACTG)
- Paediatric AIDS Clinical Trial Group (PACTG / IMPAACT)
- HIV Vaccine Trials Network (HVTN)
- HIV Prevention Trials Network (HPTN)
- Central HIV Aids Vaccine Immunology (CHAVI)
- International AIDS Vaccine Initiative (IAVI)
- Comprehensive International Programme of Research on AIDS-South Africa (CIPRA)
- Follow-on African Consortium for Tenofovir studies (FACTS)
- Gates funded Partners in Prevention PreP study
- Microbicides Networks (MDP and MTN)
- GlaksoSmithKline (GSK) Malaria Vaccine Initiative (MVI)
- The Human Heredity and Health in Africa (H3 Africa)
- TB Alliance
Project Managers at CLS coordinate the clinical trials from study set-up to closeout and they are the point of contact between the CLS laboratory and the research sites. The main clinical trials study sites that CLS serves include: WHC syndicates, Aurum Institute, Donald Gordon Medical Centre (DGMC) oncology, Bara oncology unit and CMJAH.
Over this time period CLS Support Project managers continued to provide laboratory support to, and built laboratory capacity in, approximately 40 different African sites and 2 sites in India.
Key aspects of support include:
- Technical laboratory support and training; including support for the validation of laboratory assays.
- GCLP implementation and regular laboratory assessments against GCLP conformance
- External Quality Assurance (EQA) monitoring
- Study specific endpoint testing
- Reagent sourcing
CLS has provided GCLP training since 2003 to build capacity for improving the quality in clinical testing laboratories in Africa. A total of 1114 delegates have been trained since inception, with 632 delegates trained between 2009 and 2014.
Certified staff manages the storage of a large number of specimens on behalf of a number of collaborating clinical trial networks and acts as the central repository for the South African Cancer Epidemiological Research Group. The CLS repository has skilled staff with core expertise in biomaterials storage, peripheral blood mononuclear cell processing and storage, logistics and sample management. Processing and storage facilities are available for conditions ranging from ambient, refrigerated, frozen and liquid nitrogen for a variety of samples. CLS has also been a successful applicant of an NIH grant for the Phase 1 H3 Africa Biorepository project.