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Research Diagnostics Laboratory

Head: Professor Lesley Scott

The Research Diagnostic group focuses on the design, development, evaluation and implementation of new diagnostic tests and quality management systems for assays specific to the developing world.  The entity also forms part of the NPP. The group comprises a multidisciplinary team of medical scientists and bioengineers. Their outputs contribute to improved services within the NHLS and specifically to transfer knowledge to the NPP, policy development for the NDoH and global quality management for several diagnostics. Since 2009, six TB diagnostic tests have been evaluated, one being the GeneXpert MTB/RIF (Cepheid), which this group assisted the NPP in implementing throughout South Africa to 207 testing sites. Part of this implementation also includes the R&D group developing a novel verification and external quality assessment product for the GeneXpert and other molecular TB tests. The product uses dried culture spot (DCS) technology and together with Professor Bavesh Kana from the Centre of Excellence for Biomedical TB Research WITS, who manufactures the raw material, the DCS product is provided as a quality management system to all GeneXpert users.

At least eight HIV related diagnostic tests have been evaluated, and a quality monitoring programme for HIV viral load testing also has been developed and used to assist the NHLS in rapidly implementing high throughput viral load testing in 17 new testing sites country wide. Both the TB and HIV quality programs have also been applied to evaluating new technologies for POC testing. Through a Grand Challenges Canada POCT implementation award, this group has also evaluated several POC technologies and the study has generated several policy guidelines for the future of POCT for ART/TB treatment initiation in South Africa.  Through their experiences gained on POCT, this group has contributed to the WHO, CDC and London School of Tropical Medicine for POCT policy development.

The staff members assist in teaching the BEngSc (Bachelor of Engineering Science Degree in Biomedical) Molecular Medicine students. Statistical method comparison and molecular diagnostics lectures are provided to the BSc Honours students in the department. The R&D ethics programme for the Department of Molecular Medicine and Haematology is still managed by this group.