Otsuka’s clinical trials of a compound against multidrug-resistant tuberculosis (MDR-TB) involved over 850 participants at several sites in 12 countries*.

This manual was developed to ensure high quality results and comparability of data from international TB laboratories.

The manual consists of standardised procedures related to sputum collection, handling, analyses, and reporting, with a focus on testing for the greatest impact on microbiology endpoints for MDR-TB clinical trials (sputum culture conversion in liquid and solid media).

The Mycobacteriology Laboratory Manual was launched by Otsuka and the World Health Organization’s Global Laboratory Initiative (GLI) working group of the Stop TB Partnership to serve the TB community in conducting and executing high-quality clinical research.


*China, Egypt, Estonia, Japan, South Korea, Latvia, Lithuania, Moldova, Peru, the Philippines, South Africa and the United States.


Information current as of 30-12-2020
Reference ONP-COP-2000001