title: FIND Tuberculosis Strain Bank: a Resource for Researchers and Developers Working on Tests To Detect Mycobacterium tuberculosis and Related Drug Resistance.
abstract: The spread of multidrug-resistant (MDR) tuberculosis (TB) and extensively drug-resistant (XDR) TB hampers global efforts in the fight against tuberculosis. To enhance the development and evaluation of diagnostic tests quickly and efficiently, well-characterized strains and samples from drug-resistant tuberculosis patients are necessary. In this project, the Foundation for Innovative New Diagnostics (FIND) has focused on the collection, characterization, and storage of such well-characterized reference materials and making them available to researchers and developers. The collection is being conducted at multiple centers in Southeast Asia, South America, Eastern Europe, and soon the sub-Saharan Africa regions. Strains are characterized for their phenotypic resistances and MICs to first-line drugs (FLDs) and second-line drugs (SLDs) using the automated MGIT 960 system following validated procedures and WHO criteria. Analysis of resistance-associated mutations is done by whole-genome sequencing (WGS) using the Illumina NextSeq system. Mycobacterial interspersed repetitive-unit-variable-number tandem-repeat analysis and WGS are used to determine strain lineages. All strains are maintained frozen at -80°C ± 10°C as distinct mother and daughter lots. All strains are extensively quality assured. The data presented here represent an analysis of the initial part of the collection. Currently, the bank contains 118 unique strains with extracted genomic DNA and matched sputum, serum, and plasma samples and will be expanded to a minimum of 1,000 unique strains over the next 3 years. Analysis of the current strains by phenotypic resistance testing shows 102 (86.4%), 10 (8.5%), and 6 (5.1%) MDR, XDR, and mono/poly resistant strains, respectively. Two of the strains are resistant to all 11 drugs that were phenotypically tested. WGS mutation analysis revealed FLD resistance-associated mutations in therpoB,katG,inhA,embB,embA, andpncAgenes; SLD resistance in thegyrA,gyrB,rrs,eis, andtlyAgenes; and ethionamide resistance in theethAgenes. Most important lineages are represented in the bank, and further collections have been initiated to increase geographic and lineage diversity. The bank provides highly characterized and high-quality strains as a resource for researchers and developers in support of the development and evaluation of new diagnostics and drug resistance detection tools.
authors.affiliation: Foundation for Innovative New Diagnostics, Geneva, Switzerland.|Department of Medical Microbiology, University of Gondar, Gondar, Ethiopia.
authors.forename: Belay
authors.initials: B
authors.lastname: Tessema
authors.affiliation: Foundation for Innovative New Diagnostics, Geneva, Switzerland.
authors.forename: Pamela
authors.initials: P
authors.lastname: Nabeta
authors.affiliation: Foundation for Innovative New Diagnostics, Geneva, Switzerland.
authors.forename: Eloise
authors.initials: E
authors.lastname: Valli
authors.affiliation: Foundation for Innovative New Diagnostics, Geneva, Switzerland.
authors.forename: Audrey
authors.initials: A
authors.lastname: Albertini
authors.affiliation: Universidad Peruana Cayetano Heredia, Lima, Peru.
authors.forename: Jimena
authors.initials: J
authors.lastname: Collantes
authors.affiliation: Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam.
authors.forename: Nguyen Huu
authors.initials: NH
authors.lastname: Lan
authors.affiliation: National Reference TB Laboratory, Institute of Phthisiopneumology, Chisinau, Moldova.
authors.forename: Elena
authors.initials: E
authors.lastname: Romancenco
authors.affiliation: National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia.
authors.forename: Nestani
authors.initials: N
authors.lastname: Tukavdze
authors.affiliation: Foundation for Innovative New Diagnostics, Geneva, Switzerland.
authors.forename: Claudia M
authors.initials: CM
authors.lastname: Denkinger
authors.affiliation: Foundation for Innovative New Diagnostics, Geneva, Switzerland david.dolinger@finddx.org.
authors.forename: David L
authors.initials: DL
authors.lastname: Dolinger
mesh_terms: D018070:Biological Specimen Banks; D024881:Drug Resistance, Bacterial; D006801:Humans; D007391:International Cooperation; D009169:Mycobacterium tuberculosis / Q000187:drug effects / Q000302:isolation & purification*; D018088:Tuberculosis, Multidrug-Resistant / Q000175:diagnosis* / Q000382:microbiology
keywords: diagnostics development; drug-resistant tuberculosis; strain bank