This manual describes standardized procedures related to sputum collection, handling, analyses, and reporting, with a focus on testing that has the greatest impact on microbiology endpoints for MDR-TB clinical trials (sputum culture conversion in liquid and solid media).
This manual was developed to ensure high-quality results and data comparability for a network of international tuberculosis laboratories handling sputum specimens for multidrug-resistant tuberculosis (MDR-TB) clinical trials. It focuses on testing procedures with the greatest impact on microbiology endpoints, specifically sputum culture conversion in liquid and solid media.
This document was developed to ensure high quality results and comparability of data from a network of international tuberculosis laboratories handling sputum specimens for Otsuka Pharmaceutical Development and Commercialization-sponsored multidrug-resistant tuberculosis clinical trials.
The manual focuses on testing that has the greatest impact on microbiology endpoints for MDR-TB clinical trials, specifically sputum culture conversion in liquid and solid media.
The first version was drafted by a specialized Otsuka team including a microbiology expert, a senior clinical research associate, and a senior laboratory technologist.