FIND manages several collections, including its own and two for WHO, of well-characterized TB specimens for use by researchers, developers and manufacturers of TB diagnostics. Providing access to these specimens serves to support the development and evaluation of new and existing tools to improve TB diagnosis.
Since 2015, FIND has added strains and DNA from MDR-TB and pre-XDR-TB patients, and a Molecular Developers Toolset with inactivated panels for limit of detection assessment. FIND is currently developing a virtual strain bank that will enable researchers to identify strains housed at FIND and in other available collections.
All specimens are collected at qualified clinics, under a protocol approved by an Institutional Review Board (IRB) and with informed consent from patients meeting the inclusion criteria for sample collection. FIND follows good clinical and laboratory practice in obtaining and processing samples. Samples types range from sputum to urine, plasma and serum. If special collection methodology or sample matrix is required, requestors can email inquiries to firstname.lastname@example.org.
All requests for samples are made by submitting a Material Request Form (see link below) and Material Transfer Agreement (part of the request form). Each request is reviewed by the Specimen Bank Review Committee (SBRC). Upon approval, samples are prepared and shipped to the requestor. All sample requestors/recipients are encouraged to report back with the data derived from their use of FIND samples (see link to report template below).
The samples are stored in, and distributed from, central repositories in France and the U.S.
|Yearly reports on requests filled, specimens shipped|
|TB Specimen Bank Report Q3 2015 – Q3 2016|
|TB Specimen Bank Report 2014 – Q2 2015|
Please direct any questions to: email@example.com
Specimens are collected from globally representative sites in South America, South East Asia, Africa and Eastern Europe. These specimens (sputum, plasma, serum, PAXgene tubes) are matched with strain isolates and DNA preparations. Characterization includes whole genome sequencing and phenotypic testing against first- and second-line drugs and the minimal inhibitor concentration (MIC).
Some 500 strains will be available by the end of 2016, approaching 1000 strains by October 2017.
Molecular Developers Toolset
This toolset will allow manufacturers and researchers to work with standardized panels of drug-resistant and drug-sensitive strains. The panels enable testing for dynamic range and limit of detection, comparing performance between different assays and performing external quality assurance.
The well-characterized strains included in the panel are inactivated by a proprietary method and re-suspended at a set concentration. The panel members are non-infectious and stable at 2-8° C. The initial panel contains five strains across a number of different lineages with one member being resistant to rifampicin. FIND has plans to expand the panel to include additional drug-resistant MDR and XDR strains.
Virtual Strain Bank
The Virtual Strain Bank (VSB), currently in development, is a database with a web-based interface that will allow researchers and test developers an overview of globally accessible TB strains.
The VSB will be easily searchable, with strains selected based on criteria including country, clade, drug resistance, drug sensitivity, mutations and sequencing data availability. Interested test developers can contact the owner of desired strains to obtain access. As such, the portal will further facilitate collaboration among TB researchers and developers.
Initially, the VSB will contain the relevant meta-data for all available FIND strains. In addition, other bio-repositories and researchers are being invited to share information on the isolates they house in their biobanks, while maintaining ownership and control over their strains.