What types of samples are available?
The tuberculosis specimen bank contains samples from consenting adult patients with symptoms of pulmonary tuberculosis, including:
- 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
The collection has recently been expanded to include specimens from drug-resistant TB patients and peripheral blood mononuclear cells. Following requests from test developers for more samples from HIV positive patients and patients with latent tuberculosis, we are increasing the availability of such specimens. We are also adding poly-resistant tuberculosis strains and will begin managing requests for malaria and Ebola specimen banks.
Please note that the volume of serum and plasma aliquots provided will be in the range of 300-500 µL.
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:
Sample type Processing 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.
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.
Who can request specimens?
Samples are available by application to commercial and academic researchers working towards the development of TB diagnostics suitable for low and middle-income settings.
What is the process for requesting specimens?
Requests should be made using the Material Request Form (MRF) and submitted via the web-portal: https://www.finddx.org/specimen-banks/material-request-form/. Please contact email@example.com in case of questions.
All applicants are required to sign the Material Transfer Agreement (MTA) that is annexed to the Material Request Form (MRF) and to then submit an electronic version (in editable Word and PDF format) of the MTA with the original via the web-portal. 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.
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.
How will the request be evaluated?
The aim in maintaining the specimen bank 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
Numbers of samples requested should be 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.
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.
How long does it take?
Process Time MRF review by SBRC committee up to 4 weeks from submission* Sample preparation up to 1 week*, depending on shipment size Transit time up to 1 week*, depending on distance and customs regulations in receiving country
*Should additional delays be expected, FIND will inform the requester immediately.
How are samples distributed?
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 requester to use the most recently collected samples.
Who applies for and receives samples?
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.
Who does FIND partner with to maintain the TB specimen bank?
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).