Johannesburg, South Africa SRL

Description

In 2016, the Centre for Tuberculosis (National Institute for Communicable Diseases) has been successfully evaluated for its reference laboratory potential, resulting in it being awarded the responsibility to function as the 3rd Supra-National Reference Laboratory of the WHO on the African continent. As part of this function, it provides technical support to two national reference laboratories in Africa, namely those in Malawi and Namibia. Progressive missions to improve quality management systems for laboratory testing, as well as programme initiatives towards TB surveillance activities, have been performed in these countries. In addition, the Centre provided reference laboratory support to the Malawi Prevalence Survey and the Namibia Drug Resistance Survey for both quality assurance and second-line DST. An expanded approach, aiming to assess the proficiency of nine of the 22 highest burden TB national reference laboratories in Africa on culture identification and DST, has been recently initiated through WHO-AFRO. Although the performance of countries in the first round was sub-optimal for several countries, feedback and further provision of quality-related support has resulted in an overall improvement in the quality of results generated by these laboratories. These developments have been important and have shown the great value of the support functions conducted by CTB.

Structure and organization

In line with the mandate of the National Institute for Communicable Diseases, the Centre for Tuberculosis (CTB) conducts laboratory-based public health surveillance of TB in South Africa, serves as a National TB reference laboratory (NTBRL) and participates in microbiology and epidemiology-oriented training programmes. The CTB also initiates applied public health research aimed at providing enhanced intelligence on the drivers and protective factors that underlie the TB epidemic in South Africa. The Centre for Tuberculosis laboratory facilities includes a P3 laboratory (356 m2 ) for handling of viable infectious agents and a P2 laboratory (331 m2) for downstream molecular, typing and sequencing applications. Our Laboratories have a range of conventional and molecular diagnostics used for the detection, identification, resistance profiling and stain typing of mycobacteria. The facility is currently accredited (Practice No.: PR 5200296) by the South African National Accreditation System in accordance with the recognized International Standard ISO15189:2012.

The Centre currently employs 34 staff which includes, Clinical Microbiologist, Biomedical Scientist, Epidemiologist, Biostatistician, Project Administrators, Medical Technologist and Technicians and an office administration team.

Services provided by the SRL

• Advises and works closely with the National Department of Health (DoH) on strategic planning and

• assists with policy and guideline formulation concerning the diagnosis, treatment and surveillance of

• TB in South Africa.

• Global policies and guidelines are initiated through the World Health Organization (WHO) and their

• formulation has included representation from the CTB which assisted in developing these strategic

• documents.

• Population Research/Surveys

• Public Health Surveillance

• Advancing: Diagnostics, Epidemiology & Treatment

• Outbreak Response

• Education and Training

    Laboratory Specific procedures:

• Ziehl-Neelsen & Fluorescent (Auramine) Microscopy

• Automated Liquid Culture – MGIT 960

• Conventional solid culture (Middlebrook & LJ)

• MGIT TBc Identification & in-house IS6110 & MPB64 real-time PCR

• Drug Suceptibility testing (1 st line, 2 nd line, Bedaquiline, Clofazamine, Delaminid, Linezolid)

  • EpiCenter TB eXiST

  • Agar Proportion Method

  • E-test (Clarithromycin)

  • Sensititre

    • MYCOTB

    • RAPMYCO

    • SLOMYCO

    • MIC testing on MGIT/AGAR/Broth Microdilution

• Line Probe Assays:

  • GenoType MTBDR plus

  • GenoType Mycobacterium CM/ASMTB CM

  • GenoType MTBDRsl

• GeneXpert Mtb/Rif Assay

• Molecular typing:

  • Spoligotyping

  • Automated MIRU-VNTR 24 loci

  • IS6110 RFLP

  • Automated IS6110 RFLP (RiboPrinter® System)

• Targeted sequencing: Sanger & Next-Generation sequencing

  • Rifampicin (rpoB hotspot)

  • Pyrazinamide (pncA full gene)

• Whole Genome Sequencing (Illumina) and Bioinformatic resistance analysis

Current links and partnerships outside of SRLN

• • Public Health England

  • University of Pretoria, South Africa

  • University of Free State, South Africa

  • University of Stellenbosch, South Africa

  • Center for Disease Control (Atlanta, USA)

  • University of Witwatersrand, South Africa

  • University of Cape Town, South Africa

  • University or KwaZulu Natal, South Africa

  • Oxford University, United Kingdom

  • Cambridge University, United Kingdom

  • Imperial College, United Kingdom

  • University College London

  • Rutgers University, USA

  • Columbia University, USA

  • Emory University, USA

  • ACT for TB

  • University of Michigan, USA

  • YALE, USA

  • Clinton Health Access Initiatives

  • Respiratory and Meningeal Pathogens Unit, South Africa

  • Bill and Melinda Gates Foundation

  • Medical Research Council, South Africa & United Kingdom

  • Foundation for Innovative and New Diagnostics