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Published on: April 25, 2014
The TDR Tuberculosis Specimen Bank: a resource for diagnostic test developers.
C-M Nathanson1, L E Cuevas, J Cunningham
1United Nation's Children's Fund/United Nations Development Programme/World Bank/World Health Organization Special Programme for Research and Training in Tropical Diseases (TDR), Geneva, Switzerland.
Summary
A specimen bank was created to evaluate tuberculosis (TB) diagnostics. While it provided valuable experience and quality samples, current collections may not meet future needs for TB diagnostic development.
Area of Science:
- Tropical diseases research
- Diagnostic tool development
- Biobanking
Background:
- Established in 1999 by the Special Programme for Research and Training in Tropical Diseases.
- Aimed to support the development and evaluation of novel tuberculosis (TB) diagnostic tools.
- Operates specimen collection sites in diverse global settings.
Purpose of the Study:
- Narrate the specimen bank's development.
- Discuss lessons learned, limitations, and future applications.
- Assess the utility of commercial lateral flow tests for TB diagnosis.
Main Methods:
- Collected serum, sputum, saliva, and urine samples from TB patients.
- Enrolled patients who consented to TB and human immunodeficiency virus (HIV) testing.
- Distributed samples to researchers for diagnostic test evaluation.
Main Results:
- Stockpiled 41,437 samples from 2,524 patients across 11 global sites.
- Reviewed 95 specimen requests, approving 67 for distribution.
- Evaluated 19 commercial lateral flow tests, finding none with broad global utility for TB diagnosis.
Conclusions:
- The specimen bank has yielded significant experience and provided quality specimens.
- Current sample types and quantities may not meet future end-user demands.
- Ongoing reviews aim to optimize collection and distribution for enhanced product development impact.
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