Overview

The TBRU Tuberculosis Specimen Repository [the Repository] has been established to collect, maintain, and distribute high quality clinical specimens collected during approved TBRU studies. Such specimens can be a valuable source of materials for future studies.

Funds to support the operations of the Repository come from the NIH/NIAID/DMID Contract to Case Western Reserve University to support the TBRU. The Contract Work Statement describes the overall functions of the repository.

Work Statement

Establish and/or maintain a repository of clinical samples, including, but not limited to, sera and sputa from patients involved in all clinical trials supported by this contract, and human tissue samples such as autopsy, surgical and aspirate specimens from well-characterized tuberculosis patients and controls, where possible, and distribute these specimens to qualified investigators, with the approval of the Project Officer.

Description

The TBRU Tuberculosis Specimen Repository currently contains more than 100,000 specimens. Most of these specimens were collected during TBRU clinical trials and household contact studies. These trials and studies are located primarily in Kampala, Uganda at Makerere University, and in Vitoria, Brazil at the Federal University of Espirito Santo. Additional specimens are currently being collected at the Philippines Project Site. Additional sites for TBRU clinical trials may be implemented this providing samples tothe repository.

Clinical specimens, such as sputum, gastric aspirates, blood, urine, and so forth, are collected during approved TBRU clinical trials and household contact studies. These specimens are normally processed and stored frozen at -80°C in small aliquots until they are needed. Cultures of M. tuberculosis strains isolated from patient before and during treatment are also collected, characterized, and maintained. The majority of these materials are utilized for studies planned as part of the approved TBRU studies. The Repository is responsible for maintaining and distributing these specimens. Aliquots that are not used are stored for future studies. Such specimens are available for distribution for use in both TBRU and non-TBRU studies to qualified users approved by the NIAID Tuberculosis Program Officer.

Operation

TBRU Repository specimens are first collected, processed, and stored in freezers at the study site. Many of these specimens are used on-site for studies related to the clinical protocol under which the specimens were collected. Others may be shipped to TBRU laboratories located in other sites for additional studies. Unused specimens may be transported to the Repository site in Cleveland for long-term storage and future distribution. The Repository usually ships specimens in liquid nitrogen “dry shippers” although some specimens may be transported in dry ice or at ambient temperature, depending upon the conditions necessary to maintain sample integrity during transit.

Bar-coded specimens in the various Repository sites can be located, manipulated, shipped, and received using Freezerworks Unlimited from Dataworks, Inc.

Staff

Dr. John Foulds directs the activities of the TBRU Specimen Repository with the assistance of Ms. Dana Drzayich-Jankus. A dedicated Repository Manager, Ms. Lisa Kucharski, is responsible for the day-to-day operations of the Specimen Repository including international shipping, maintenance of specimens at the Cleveland Repository site, and management of a collaboration-wide specimen inventory. Ms. Kucharski also receives and processes internal and external requests for use of specimens from the TBRU Repository.