Target product profile of a molecular drug-susceptibility test for use in microscopy centers

The Journal of Infectious Diseases
Claudia M DenkingerMark D Perkins

Abstract

Current phenotypic testing for drug resistance in patients with tuberculosis is inadequate primarily with respect to turnaround time. Molecular tests hold the promise of an improved time to diagnosis. A target product profile for a molecular drug-susceptibility test (DST) was developed on the basis of a collaborative effort that included opinions gathered from researchers, clinicians, policy makers, and test developers on optimal clinical and operational characteristics in settings of intended use. In addition, the current diagnostic ecosystem and the diagnostic development landscape were mapped. Molecular DSTs for detecting tuberculosis in microscopy centers should ideally evaluate for resistance to rifampin, fluoroquinolones, isoniazid, and pyrazinamide and enable the selection of the most appropriate treatment regimen. Performance characteristics of DSTs need to be optimized, but compromises can be made that depend on the trade-off between a false-positive result and a false-negative result. The operational requirements of a test will vary depending on the site of implementation. However, the most-important considerations pertain to quality control, maintenance and calibration, and the ability to export data. This target pro...Continue Reading

References

Dec 13, 2003·Archives of Disease in Childhood·H S SchaafP R Donald
Feb 13, 2009·PLoS Medicine·Andreas SandgrenMegan B Murray
May 2, 2009·American Journal of Respiratory and Critical Care Medicine·Susan E DormanUNKNOWN Tuberculosis Trials Consortium
Jun 13, 2009·BMC Infectious Diseases·Chandrashekhar T SreeramareddyJ Van den Ende
Oct 17, 2009·Clinical Microbiology and Infection : the Official Publication of the European Society of Clinical Microbiology and Infectious Diseases·H AndoT Kirikae
May 28, 2010·Journal of Clinical Microbiology·Robert BlakemoreDavid Alland
Apr 13, 2011·Clinical Microbiology Reviews·Linda M ParsonsJohn Nkengasong
Dec 6, 2011·The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease·S E SmithJ P Cegielski
Jan 13, 2012·The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease·H M SaidM M Ehlers
Apr 6, 2012·The Journal of Infectious Diseases·Frank CobelensUNKNOWN Evidence for Scale-up Group
May 11, 2012·Journal of Clinical Microbiology·Claudia M DenkingerMadhukar Pai
Jul 6, 2012·The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease·J H GrossetW R Bishai
Oct 5, 2012·South African Medical Journal = Suid-Afrikaanse Tydskrif Vir Geneeskunde·Kate ClouseAnnelies Van Rie
Oct 23, 2012·American Journal of Respiratory and Critical Care Medicine·Marinus BarnardRichard O'Brien
Oct 27, 2012·The European Respiratory Journal·Dennis FalzonUNKNOWN Collaborative Group for Meta-Analysis of Individual Patient Data in MDR-TB
Nov 17, 2012·Expert Review of Molecular Diagnostics·Angelika Niemz, David S Boyle
Feb 14, 2013·Journal of the Royal Army Medical Corps·M J World
Mar 28, 2013·The Lancet Infectious Diseases·William A WellsMarco Schito
Apr 2, 2013·The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease·C M DenkingerM Pai
Apr 12, 2013·The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease·Madhukar Pai
Apr 12, 2013·The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease·M M ClaassensM W Borgdorff
Apr 12, 2013·Science Translational Medicine·Harriet L MillsCaroline Colijn
Aug 2, 2013·The European Respiratory Journal·Claudia M DenkingerMadhukar Pai
Oct 25, 2013·Expert Review of Molecular Diagnostics·Claudia M DenkingerMadhukar Pai
Jan 23, 2014·The Cochrane Database of Systematic Reviews·Karen R SteingartNandini Dendukuri
Feb 15, 2014·The European Respiratory Journal·Sandra V KikMadhukar Pai
Jun 7, 2014·The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease·D W DowdyF Cobelens
Aug 8, 2014·PloS One·UNKNOWN TB Diagnostics Market Analysis Consortium
Sep 10, 2014·The New England Journal of Medicine·Stephen H GillespieUNKNOWN REMoxTB Consortium

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Citations

Mar 15, 2015·The Journal of Infectious Diseases·Madhukar Pai, Marco Schito
Mar 17, 2017·Journal of Clinical Microbiology·Robyn S Lee, Madhukar Pai
Nov 22, 2019·BMJ Global Health·Richard G MatherSabine Dittrich
Jun 22, 2019·BMC Research Notes·Annelies W MesmanMolly F Franke
Aug 8, 2020·Journal of Clinical Microbiology·Emily MacLeanMadhukar Pai
Nov 17, 2017·BMC Infectious Diseases·Elena Ivanova ReipoldClaudia Denkinger
Oct 20, 2018·Nature Reviews. Microbiology·Alex van BelkumUNKNOWN JPIAMR AMR-RDT Working Group on Antimicrobial Resistance and Rapid Diagnostic Testing
May 12, 2020·BMC Medicine·Paola CoccoBethany Shinkins
Jun 30, 2019·BMC Infectious Diseases·Annelies W MesmanMolly F Franke
May 15, 2021·Immunological Reviews·Annemieke Geluk
Oct 21, 2016·Microbiology Spectrum·Madhukar PaiCatharina C Boehme

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