Performance of the low-cost phenotypic thin-layer agar MDR/XDR-TB Colour Test (first generation, 1G, Color Plate Test) for identifying drug-resistant Mycobacterium tuberculosis isolates in a resource-limited setting
Abstract
BACKGROUND: The accessible, easy to use and timely, diagnosis of tuberculosis (TB) drug-susceptibility, is often challenging, particularly in resource-constrained settings. We therefore evaluated the phenotypic thin-layer agar based MDR/XDR-TB Colour Test, also known as the "First Generation (1G) Color Plate Test (TB-CX)" performance for detecting resistance of Mycobacterium tuberculosis (Mtb) isolates to selected anti-TB drugs versus other tests routinely used in our setting.
METHODS: A cross-sectional study was conducted on Mtb clinical isolates stored at the Armauer Hansen Research Institute TB laboratory in Addis Ababa, Ethiopia. Drug-susceptibility testing was performed on 78 Mtb isolates for isoniazid, rifampicin, and moxifloxacin using the Colour Test and the Indirect Proportional Method (IPM) "in house" assay. Isoniazid and rifampicin were also evaluated by the Mycobacterial Growth Indicator Tube (MGIT) commercially available assay. Test accuracy was calculated as % agreement with 95% confidence intervals (95%CI).
RESULTS: The median (range) times in days determining Mtb resistance or susceptibility for the Colour Test, IPM and MGIT assays were of 9 (5-18), 15 (13-18) and 19 (14-21) days, respectively. The Colour Test provided results significantly (p < 0.001) more rapidly than the IPM or MGIT assays. The colour test showed a sensitivity and specificity of 91%(95% CI: 87-96) and 87%(95% CI:75-95) for detecting isoniazid resistance,and 93%(95% CI:81-99) and 92%(95%…
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Evidence Hub reads this as a cross-sectional, done in people. Its evidence level is 4 of 5 (Low · observational). Observational designs can show an association but not prove cause.
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