Tuberculosis (TB) specimen bank
FIND manages a bank of well-characterized tuberculosis specimens for commercial and academic researchers working on the development of TB diagnostics. By providing access to needed TB specimens from FIND and WHO collections, we aim to support the development and evaluation of new and existing tools to improve the diagnosis of TB in low- and middle-income countries.
The specimens include sputum, serum, plasma, urine and saliva, and are collected at participating clinics around the world from consenting adults with symptoms of pulmonary tuberculosis. Given the urgency of developing tools for timely diagnosis of drug-resistant TB, the collection has recently been expanded to include specimens from drug-resistant TB patients as well. Should a researcher require a particular type of sample not available at the bank, an ad-hoc collection can be set-up if the research is deemed particularly valuable; feasibility, times and costs of ad-hoc collections are assessed on a case-by-case basis. FIND’s sample handling follows good clinical and laboratory practices to ensure the highest quality. The samples are stored in central repositories in France and the U.S. and are shipped to researchers upon request. The requests are screened by a committee based on scientific merits and value to the global health community. Twenty-eight requests were handled in 2014 alone.
In January 2015, we conducted a survey of TB researchers to find out what they thought of the service, what improvements could be made and what types of TB samples and strains would be most useful in their work. Of all researchers surveyed, 82% of respondents had used the FIND TB specimen bank and of those, 94% were satisfied or extremely satisfied with the service provided, and 78% found the quality of FIND’s TB specimen bank to be somewhat or much better than other specimen providers (none found the quality to be worse).
We learned about additional needs from test developers, particularly for more samples from HIV positive patients and patients with latent tuberculosis, so we plan to increase the availability of such specimens. In 2015, we will be adding poly-resistant tuberculosis strains to our sample bank to provide to researchers. We will also begin managing requests for malaria and Ebola specimen banks.
What types of samples are available?
Sputum - 0.5 ml aliquots
Serum - 0.5 ml aliquots
Plasma (EDTA) - 0.5 ml aliquots
Plasma (P800) - 0.5 ml aliquots
Saliva - 0.5 ml aliquots
Urine - 1.5ml or 3.5ml aliquots
How are samples collected and stored?
Specimens are collected from adult individuals presenting to participating clinics with symptoms of pulmonary tuberculosis. All samples are collected before the subject starts any form of TB treatment. Basic processing information for each sample type is outlined below:
|Serum and plasma||Centrifugation|
|Urine||Sedimentation or Centrifugation|
|Sputum||Homogenization with H2O or NALC/NA Citrate and glass beads|
All samples are aliquoted in pre-labelled cryotubes and frozen on site before being shipped to one of the central repositories.
All collection studies were IRB-approved and an informed consent form was signed by all participants providing samples. Samples are identified by a study ID only and no personal identifiers are included on the samples or in their relative data sets.
Who can request specimens?
Samples are available by application (Material Request Form) to commercial and academic researchers working towards the development of TB diagnostics suitable for low and middle-income settings.
How will the request be evaluated?
The first priority for this project is to assist in the development or evaluation of emerging or existing diagnostic tools that are considered promising for improving the diagnosis of TB in low and middle-income countries. A Specimen Bank Review Committee (SBRC), composed of five qualified members involved in diagnostics development and TB control, will review and approve or reject applications from requesting parties. Requests which address the following criteria will be given the highest priority:
- Relevance to public health (feasibility and impact on patients and disease control programmes)
- Applicability of the technology in high burden countries
- Low cost of final product
- Previous data or scientific evidence supporting the request
What is expected of the applicants?
All applicants are required to sign the Material Transfer Agreement (MTA) that is annexed to the Material Request Form (MRF) and to then forward an electronic copy to FIND. Changes to the MTA are generally not admitted and any proposed change will have to be reviewed and approved by FIND. Shipment of samples is dependent on a valid, fully executed MTA.
How many samples can be requested?
The suitability of the request will be evaluated by the SBRC. Sample numbers should be requested based on real needs to achieve the objectives described in the MRF. In the following cases, a more detailed workplan and supporting proof-of-principle data might be required by the SBRC on a case by case basis:
- large sample requests;
- significantly scarce diagnostic groups or sample types;
- repeated requests for the same project.
Criteria for sample selection
After approving the request, the following criteria will be considered for sample selection:
Whenever possible, all samples in a request will be shipped from one repository in order to minimize logistics, shipping costs and time. Samples will be shipped from the closest repository. To take the best advantage of all collections, samples will be selected on a first-in first-out basis, unless a case is made by the requestor to use the most recently collected samples.
Applicants are to cover handling fees and shipping costs, unless otherwise agreed with FIND. Handling fee is US$ 20 per aliquot. Shipment costs will depend on the destination address. Estimates can be provided in advance upon request.
Where are the samples stored?
Samples are currently stored in deep freezers at -80°C at two central repositories located in the US and in France. Please note that import permits are required by most countries to receive shipments of frozen biological samples. It is the responsibility of the receiver to apply for the import permit and to comply with the import and regulatory requirements of the receiving country.
How long does it take?
|MRF review by SBRC committee||up to 2 weeks from submission*|
|Sample preparation||up to 4 days*, depending on shipment size|
|Transit time||up to 5 days*, depending on distance and customs regulations in receiving country|
*Please note that the timelines are indicative and may change due to circumstances.
Transparency of use
A report summarizing the number of requests received, approved or rejected and the number and type of aliquots distributed will be made available on this website on an annual basis.
Partners: Special Programme for Research and Training in Tropical Diseases (WHO TDR), ZeptoMetrixTM Corporation (USA), Biobanque de Picardie (France), Universidad Peruana Cayetano Heredia (Peru), Pham Ngoc Thach Hospital (Vietnam), University of Cape Town (South Africa), Institute of Phthisiopneumology “Ch. Draganiuc” and National TB Reference Laboratory (Moldova), National Center for Tuberculosis and Lung Disease (Georgia), Kwazulu-Natal Research Institute for TB- HIV (South Africa), Forschungszentrum Borstel (Germany), National Jewish Health (USA).
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