RT Journal Article SR Electronic T1 Improving diagnosis and monitoring of treatment response in pulmonary tuberculosis using the molecular bacterial load assay (MBLA) JF bioRxiv FD Cold Spring Harbor Laboratory SP 555995 DO 10.1101/555995 A1 Wilber Sabiiti A1 Khalide Azam A1 Davis Kuchaka A1 Bariki Mtafya A1 Ruth Bowness A1 Katarina Oravcova A1 Eoghan C W Farmer A1 Isobella Honeyborne A1 Dimitrios Evangelopoulos A1 Timothy D McHugh A1 Han Xiao A1 Celso Khosa A1 Andrea Rachow A1 Norbert Heinrich A1 Elizabeth Kampira A1 Gerry Davies A1 Nilesh Bhatt A1 Nyanda Elias Ntinginya A1 Sofia Viegas A1 Ilesh Jani A1 Mercy Kamdolozi A1 Aaron Mdolo A1 Margaret Khonga A1 Martin J Boeree A1 Patrick PJ Philips A1 Derek J Sloan A1 Michael Hoelscher A1 Gibson Sammy Kibiki A1 Stephen H Gillespie YR 2019 UL http://biorxiv.org/content/early/2019/02/28/555995.abstract AB Objectives Better outcomes in tuberculosis require new diagnostic and treatment monitoring tools. In this paper we evaluated the utility of a marker of M. tuberculosis viable count, the Molecular Bacterial Load assay (MBLA) for diagnosis and treatment monitoring of tuberculosis in a high burden setting.Methods Patients with smear positive pulmonary tuberculosis from two sites in Tanzania and one each in Malawi and Mozambique. Sputum samples were taken weekly for the first 12 weeks of treatment and evaluated by MBLA and mycobacterial growth indicator tube method (MGIT).Results The results of high and low positive control samples confirmed inter site reproducibility. Over the 12 weeks of treatment there was a steady decline in the viable bacterial load as measured by the MBLA that corresponds to rise in time to a positive result (TTP) in the Mycobacterial Growth Indicator Tube. Both MBLA and MGIT provided similar time to test negativity. Importantly, as treatment progressed samples in MGIT were increasingly likely to be contaminated, which compromised the acquisition of results but did not affect MBLA samples.Conclusions MBLA produces a reproducible measure of Mtb viable count comparable to that of MGIT that is not compromised by contamination in a real-world setting. As a molecular test, the results can be available in as little as four hours and could allow health care professionals to identify rapidly patients who are failing therapy.