TB or not TB? Definitive determination of species within the Mycobacterium tuberculosis complex in unprocessed sputum from adults with presumed multidrug-resistant tuberculosis

OBJECTIVES—Differences among Mycobacterium tuberculosis complex (MTC) species may predict drug resistance or treatment success. Thus, we optimised and deployed the genotype MTBC assay (gMTBC) to identify MTC to the species level, and then performed comparative genotypic drug-susceptibility testing to anti-tuberculosis drugs from direct sputum of patients with presumed multidrug-resistant tuberculosis (MDR-TB) by the MTBDRplus/sl reference method. METHODS—Patients with positive Xpert® MTB/RIF (Xpert) results were consented to provide early-morning-sputum for testing by the gMTBC and the reference MTBDRplus/sl. Chi-square or Fisher’s exact test compared proportions. Modified Poisson regression modelled detection of MTC by gMTBC. RESULTS—Among 73 patients, 53 (73%) were male and had a mean age of 43 (95% CI; 40–45) years. In total, 34 (47%), 36 (49%) and 38 (55%) had positive gMTBC, culture and MTBDR respectively. Forty patients (55%) had low quantity MTC by Xpert, including 31 (78%) with a negative culture. gMTBC was more likely to be positive in patients with chest cavity 4.18 (1.31– 13.32, P = 0.016), high-quantity MTC by Xpert 3.03 (1.35–6.82, P = 0.007) and sputum smear positivity 1.93 (1.19–3.14, P = 0.008). The accuracy of gMTBC in detecting MTC was 95% (95% This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. Corresponding Author Peter M. Mbelele, Kibong’oto Infectious Diseases Hospital (KIDH), P.O BOX 12, Siha, Kilimanjaro, Tanzania. mbelelepeter@yahoo.com. Sustainable Development Goal: Good health and well-being HHS Public Access Author manuscript Trop Med Int Health. Author manuscript; available in PMC 2022 March 01. Published in final edited form as: Trop Med Int Health. 2021 September ; 26(9): 1057–1067. doi:10.1111/tmi.13638. A uhor M anscript

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