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Development of a cost-effective drug sensitivity test for multi-drug resistant and extensively drug-resistant tuberculosis
Author(s)
Patel, Fadheela
Date Issued
2010
Type
Thesis
Publisher
Cape Peninsula University of Technology
Abstract
The World Health Organisation estimates that nine million people are infected with
tuberculosis (TB) every year of which ninety-five percent live in developing countries.
Africa has one of the highest incidences of TB in the world. but few of its countries are
equipped to diagnose drug-resistant TB. This study aimed to develop a robust. yet
simple and cost-effective assay. which would require minimal sophisticated
instrumentation and specialised personnel that would make drug sensitivity screening for
multi-drug resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis
(XDR-TB) accessible to resource-poor high-burden settings.
A four-quadrant colorimetric agar plate method was developed which showed good
specificity (97.3%-100%) and sensitivity (77.8%-100%) compared to the polymerase
chain reaction (PCR) method used as gold standard. Agreement between the methods.
using Simple Kappa Coefficients. ranged between very good and excellent. all with high
statistical significance (P < 0.0001). The currently used BACTEC MGIT SIREN
sensitivity assay coupled with the E-test® strip method. as routinely used in the TB
reference laboratory. was compared and showed excellent comparison with the newlydeveloped
plate method. for each antibiotic tested. as well as the resultant monoresistant,
MDR- or XDR-TB diagnoses. Moreover. the new method was found to be
extremely cost-effective. priced at half the cost of a peR assay.
These four quadrant plates. with a colorimetric indicator and selected antibiotics. can be
considered as an economic altemative or a complimentary method for laboratories
wishing to reduce the cost and complexity for TB drug sensitivity testing. Routine
diagnostic testing would thus be made more accessible and affordable to laboratories
that are not presently diagnosing drug resistant TB. therefore enhancing case detection
and treatment in the resource-poor settings hardest hit by this curable disease.
tuberculosis (TB) every year of which ninety-five percent live in developing countries.
Africa has one of the highest incidences of TB in the world. but few of its countries are
equipped to diagnose drug-resistant TB. This study aimed to develop a robust. yet
simple and cost-effective assay. which would require minimal sophisticated
instrumentation and specialised personnel that would make drug sensitivity screening for
multi-drug resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis
(XDR-TB) accessible to resource-poor high-burden settings.
A four-quadrant colorimetric agar plate method was developed which showed good
specificity (97.3%-100%) and sensitivity (77.8%-100%) compared to the polymerase
chain reaction (PCR) method used as gold standard. Agreement between the methods.
using Simple Kappa Coefficients. ranged between very good and excellent. all with high
statistical significance (P < 0.0001). The currently used BACTEC MGIT SIREN
sensitivity assay coupled with the E-test® strip method. as routinely used in the TB
reference laboratory. was compared and showed excellent comparison with the newlydeveloped
plate method. for each antibiotic tested. as well as the resultant monoresistant,
MDR- or XDR-TB diagnoses. Moreover. the new method was found to be
extremely cost-effective. priced at half the cost of a peR assay.
These four quadrant plates. with a colorimetric indicator and selected antibiotics. can be
considered as an economic altemative or a complimentary method for laboratories
wishing to reduce the cost and complexity for TB drug sensitivity testing. Routine
diagnostic testing would thus be made more accessible and affordable to laboratories
that are not presently diagnosing drug resistant TB. therefore enhancing case detection
and treatment in the resource-poor settings hardest hit by this curable disease.
Additional information
Thesis (MTech (Biomedical Technology))--Cape Peninsula University of Technology, 2010
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