PT  - JOURNAL ARTICLE
AU  - Wilber Sabiiti
AU  - Khalide Azam
AU  - Davis Kuchaka
AU  - Bariki Mtafya
AU  - Ruth Bowness
AU  - Katarina Oravcova
AU  - Eoghan C W Farmer
AU  - Isobella Honeyborne
AU  - Dimitrios Evangelopoulos
AU  - Timothy D McHugh
AU  - Han Xiao
AU  - Celso Khosa
AU  - Andrea Rachow
AU  - Norbert Heinrich
AU  - Elizabeth Kampira
AU  - Gerry Davies
AU  - Nilesh Bhatt
AU  - Nyanda Elias Ntinginya
AU  - Sofia Viegas
AU  - Ilesh Jani
AU  - Mercy Kamdolozi
AU  - Aaron Mdolo
AU  - Margaret Khonga
AU  - Martin J Boeree
AU  - Patrick PJ Philips
AU  - Derek J Sloan
AU  - Michael Hoelscher
AU  - Gibson Sammy Kibiki
AU  - Stephen H Gillespie
TI  - Improving diagnosis and monitoring of treatment response in pulmonary tuberculosis using the molecular bacterial load assay (MBLA)
AID  - 10.1101/555995
DP  - 2019 Jan 01
TA  - bioRxiv
PG  - 555995
4099  - http://biorxiv.org/content/early/2019/02/28/555995.short
4100  - http://biorxiv.org/content/early/2019/02/28/555995.full
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.