Otsuka and the WHO’s Global Laboratory Initiative (GLI) launch new laboratory manual
23 May 2014 - Otsuka and the WHO’s Global Laboratory Initiative (GLI) working group of the Stop TB Partnership launched a new Mycobacteriology Laboratory Manual at the GLI Annual Meeting on April 30th.
The manual was originally developed to ensure high quality results and comparability of data from a network of leading international tuberculosis laboratories in nine countries - China, Egypt, Estonia, Japan, Korea, Latvia, Peru, the Philippines and the United States. These standards were applied during clinical trials of Deltyba (delamanid), Otsuka’s novel compound for multidrug-resistant tuberculosis (MDR-TB), which was recently granted marketing authorization in the European Union.
The manual contains 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). In the Appendices there are also templates that can be used to collect and store data relevant to these procedures.
The drafting and publishing of the manual was a collaborative effort between private industry, the laboratories and trial sites that participated in its implementation, the GLI Core Group members and Secretariat (hosted by the Global TB Programme, WHO) as well as representatives from the WHO/GLI TB Supranational Reference Laboratory Network that provided their comprehensive review and input.
The authors and reviewers hope the manual may serve the entire TB community in conducting and executing high-quality clinical research long into the future. Those interested in receiving complementary hard copies may contact partnership@otsuka.ch
Source: Stop TB Partnership