TASK Laboratory is a dedicated biosafety level 3 clinical trials laboratory providing high quality microbiology diagnostic services. The laboratory offers services to various investigators, clinical research organizations and trial sponsors involved in diagnosis and development of vaccines and drugs in the field of infectious diseases, particularly tuberculosis (TB). TASK Laboratory operates in accordance with the international ethical and scientific quality standard of Good Clinical Laboratory Practice (GCLP).
HISTORY
The laboratory started operating in 2005 with early bactericidal activity (EBA) testing of TMC207; the first in-patient trial with this compound. The drug was subsequently registered as bedaquiline, becoming the first FDA approved anti-TB drug in 40 years.
Since then, the laboratory has supported over 30 clinical trials ranging from two-week EBA studies to phase III long-term follow-up trials, testing new and existing anti-tuberculosis compounds as well as novel combinations for treatment of multi-drug resistant TB. In 2018, the laboratory moved from its location at Stellenbosch University’s Faculty of Health Sciences to TASK’s premises in Parow, Cape Town.
SERVICES
Sputum smear microscopy (Auramine-O and Ziehl-Neelsen)
A rapid and reliable identification of pulmonary TB in patients where there are more than 5000 bacilli/ml of sputum.
Culture
Use of liquid (Mycobacteria Growth Indicator Tube {MGIT}) and solid media (7H11 agar plates / Lowenstein-Jensen slopes) for culturing or growing Mycobacterium tuberculosis (MTB) to aid in diagnostic confirmation of TB.
Molecular testing: Xpert MTB/RIF
A semi-quantitative real-time PCR that simultaneously detects the presence of MTB complex (MTBC) and resistance to rifampicin in less than 2 hours.
HAIN line probe assays
This test uses a PCR reverse hybridization line probe strip assay to identify MTBC and mutations conferring resistance to rifampicin and isonaizid in sputum samples, and is aimed at diagnosing multidrug resistant (MDR) TB rapidly. The information provided by the Xpert MTB/RIF and HAIN line probe assay aids in selecting treatment regimens and reaching infection control decisions quickly.
Rapid chromatographic immunoassay (MPT64 antigen test)
The MPT64 antigen is highly specific for MTBC and is secreted by actively growing bacilli. Based on an immunochromatographic principle this assay allows for rapid identification from culture of MTBC and allows discrimination between MTBC and nontuberculous mycobacteria (NTM).
Phenotypic drug susceptibility testing of anti-tuberculosis drugs
Currently the gold standard for TB drug susceptibility testing, this culture-based test determines if a strain is resistant to an anti-TB drug by evaluating the growth (or metabolic activity) in the presence of the drug.
Early bactericidal activity (EBA) studies
EBA refers to a drug’s ability to kill mycobacteria originating within pulmonary cavities during the first weeks of treatment. Determination of EBA in sputum smear-positive pulmonary TB patients by quantification of viable colony-forming unit (CFU) of MTB is an important predictor of efficacy of new treatments.
Minimum inhibitory concentration (MIC) determinations of current and novel antibiotic compounds.
The MIC is of a drug is determined by incubating cultured microorganisms in liquid or on solid growth medium in the presence of varying concentration of the drug. The concentration at which no growth is observed is the MIC of the drug. A lower MIC value indicates that less drug is required for inhibiting growth of the organism; therefore, drugs with lower MIC scores are more effective antimicrobial agents.
Accreditation, certification and registration
• SANAS accredited under the ISO15189 standard, facility accreditation number: M0734. The South African National Accreditation System (SANAS) is the single, national accreditation body giving laboratories formal recognition of their competence to perform specific tasks.
• Registered with the South African Department of Health; authorised to keep, use or handle cultures or preparations of micro-organisms.
• Registered with South African Council for the Non-Proliferation of Weapons of Mass Destruction – a statutory body established to regulate strategic goods and technologies that could be used in the development and
production of weapons of mass destruction.
• Laboratory certified to standards listed below:
• World Health Organisation Biosafety,
• National Institute of Health Design Guidelines
• Centre for Disease Control biosafety protocols and regulations
