Seminar #11

Quality needs for Molecular TB/HIV and HPV diagnostic assays applied in clinical laboratories

AIDS Clinical Trial Group (ACTG)

No invitations necessary; open to all conference registrants

Sunday, 4 December 
8:00 – 12:00
CTICC room location: 2.61-2.63

The target audience will be anatomical and clinical pathologists, molecular scientists and technologists requiring updated information on clinically relevant diagnostics, with a special focus on quality requirements which now also need to extend to point of care and field based testing.


The AIDS Clinical Trials Group (ACTG), established in 1987, is one of the largest global HIV clinical trials organizations playing a major role in setting standards of care for HIV infection and opportunistic diseases related to HIV and AIDS. ACTG supports the largest Network of expert clinical and translational investigators and therapeutic clinical trials units in the world, including sites in resource-limited countries.

These investigators and units serve as the major resource for HIV/AIDS research, treatment, care, and training/education in their communities. This workshop therefore focuses on quality needs for clinical laboratories performing molecular diagnostics for TB, HIV and HPV, and shares experiences of successful introduction of clinical trial related EQA into pathology laboratories in resource limited settings


  1. Insight into molecular diagnostics for TB, HIV and HPV
  2. Insight into successful quality programs for the molecular clinical laboratory
  3. Translating quality needs to point of care testing
  4. Translating molecular diagnostics into clincial practice
  5. Harmonisation of anatomical and clinical needs in the context of clinical trials


Lesley Scott, Uniwersity of the Witwatersrand, Welcome and brief Introduction
Lesley Scott is an Associate Professor in the department of Molecular Medicine and Haematology and overseas Research and Development in molecular diagnostics with the National Priority Programs of the National Health Laboratory Service.  She specialises in design, development, evaluation, implementation and quality management of new molecular diagnostics for HIV and tuberculosis for disease diagnosis and monitoring to impact on global health with a special focus on resource limited settings. 

Andrew Whitelaw, National Health Laboratory Service, 1. Brief overview of molecular TB diagnostics routinely applied in clinical laboratories
Andrew Whitelaw is currently the head of the Division of Clinical Microbiology at Stellenbosch University and NHLS Tygerberg Hospital, prior to which he was a consultant in the department of microbiology at NHLS Groote Schuur Hospital. His research interests include TB diagnosis and epidemiology, and he has been working with the NHLS subcommittee and the NHLS NPP on standardisation of TB laboratory practices. 

Anura David, University of the Witwatersrand, Experience from quality monitoring options for molecular TB diagnostics (verification and EQA
Anura David is a Medical Scientist in the Department of Molecular Medicine and Haematology at the University of the Witwatersrand, working in the Microbiology field with a focus on Mycobacterium tuberculosis (MTBC) laboratory diagnostics and quality management. Her current research activities involve the co-ordination of clinical trials to evaluate new MTBC diagnostics, and she is the Operations Manager for the GeneXpert and LPA international External Quality Assessment Program (EQA) programs with coordination through the ACTG TB working group. 

Pedro Da Silva, National Health Laboratory Service, Molecular TB diagnostic’s clinical interpretation and lessons learned from the field
Pedro da Silva is a specialist pathologist in the field of clinical microbiology. He currently oversees operations at the National Priority Programs Division of the NHLS and is involved in the management of clinical TB diagnostic trials at Clinical Laboratory Services (CLS). He has a joint appointment with the University of the Witwatersrand, Johannesburg. Previously, Dr Da Silva headed the Mycobacteriology Referral Laboratory, Braamfontein, which supplies tuberculosis diagnostic services to the state health sectors of Gauteng, Mpumalanga, North West and Limpopo Provinces. 

Natasha Gous, National Health Laboratory Service,Quality needs for HIV VL and EID in an era of POC testing
Natasha Gous is the Program Manager for the Point of Care testing portfolio for the National Health Laboratory Service National Priority Programs.  She is an applied Research and developmental scientist with over 8 years of experience in the validation of molecular diagnostic systems for infectious diseases. Her main research activities focus on the evaluation of HIV and TB Point of Care technologies, with a special interest in the operational requirements for multi-disciplinary POCT in South Africa. 

Robert Coombs, University of Washington and ACTG and Lesley Scott, University of the Witwatersrand, Experience from VQA, SAVQA and the role of DBS on HIV VL testing
Dr. Coombs has extensive expertise in the field of clinical HIV virology. In addition to his responsibilities as Director of the University of Washington (UW), Department of Laboratory Medicine’s Diagnostic HIV Retrovirology Laboratory, he is Medical Director of the UW Medical Center Virology/AIDS Roosevelt Clinic. He has had a leadership role in the AIDS Clinical Trial Group (ACTG) Network Laboratory program for the past 28 years and in that capacity, overseen the expansion of the ACTG Virology program to provide protocol support at both domestic and international laboratory sites.

Dr. Pamela Michelow 
Dr Pamela Michelow has a joint post, principal medical officer in the Cytology Unit, National Health Laboratory Service and senior researcher in the Department of Anatomical Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. Dr Michelow has published several dozen articles in peer-reviewed journal and co-authored a number of cytopathology textbooks.  In addition to routine diagnostic work within the cytology unit, Dr Michelow facilitates the unit’s quality assurance activities and organises their academic programme. Her special interests include screening programmes in resource-constrained settings, the cytopathology of HIV/AIDS, and the teaching and learning of cytopathology.

Dr. Wallis
Dr Wallis is the Medical Director and the Head of the Specialty Molecular Division for BARC-SA and Lancet laboratories, respectively and has a broad background in virology and molecular techniques.  Her laboratory is the regional TB laboratory for the ACTG and she is the virologist on seven ACTG protocols which focus on optimising treatment in HIV infected individuals with or without TB and other co-infections. She has published widely in her field of HIV drug resistance and molecular pathology.