News

New Laboratory Resource Handbook Published for Support of TB Clinical Trials


17 Apr 2018
by Working Group

A new laborartory resource handbook was published in March 2018 to support TB clinical trials. The authors and summary of the handbook are below. Please click here for a link to the full handbook.  

Authors

Kathleen Eisenach, University of Arkansas for Medical Sciences, USA
Anne-Marie Demers, Desmond Tutu TB Centre, Stellenbosch Uni, South Africa
Fatima Jones, Westat, USA

Summary

The Mycobacteriology Laboratory Sourcebook for Harmonization and Support of Tuberculosis (TB) Clinical Trials was developed to ensure high quality results and comparability of data across laboratories participating in TB clinical trials sponsored by the AIDS Clinical Trials Group (ACTG) and International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Networks. The essential technical components of mycobacteriology laboratory procedures that can affect the microbiology endpoints of the study, comparability and quality of results, and participant safety are described. These are referred to as Key Elements. The Sourcebook also discusses how test results are used in the context of clinical trials. All the routine procedures performed with respiratory specimens, including collection and transport, are included with a focus on the Key Elements and important technical points. TB laboratory specialists with experience in TB drug trials, and who are a part of the ACTG and IMPAACT Networks, were involved in defining the Key Elements and important technical points. The Sourcebook was developed as a reference for all laboratorians participating in TB clinical studies; however, it will also be informative for clinical staff involved in studies and those developing study protocols. Checklists consisting of the Key Elements and other important technical points for each of the laboratory procedures are included to assist the laboratories in performing self-assessments and auditors in assessing procedures for quality elements.

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