TY - JOUR
T1 - Clinical research and development of tuberculosis diagnostics
T2 - Moving from silos to synergy
AU - Nahid, Payam
AU - Kim, Peter S.
AU - Evans, Carlton A.
AU - Alland, David
AU - Barer, Michael
AU - Diefenbach, Jane
AU - Ellner, Jerrold
AU - Hafner, Richard
AU - Hamilton, Carol Dukes
AU - Iademarco, Michael F.
AU - Ireton, Gregory
AU - Kimerling, Michael E.
AU - Lienhardt, Christian
AU - MacKenzie, William R.
AU - Murray, Megan
AU - Perkins, Mark D.
AU - Posey, Jamie E.
AU - Roberts, Teri
AU - Sizemore, Christine
AU - Stevens, Wendy S.
AU - Via, Laura
AU - Williams, Sharon D.
AU - Yew, Wing W.
AU - Swindells, Susan
N1 - Funding Information:
Potential conflicts of interest. M. P. has no commercial associations or other conflicts of interest relevant to the work presented. He was supported by a grant from the Bill and Melinda Gates Foundation (grant number 28766.01). A. D. reports that he and his laboratory receive licensing income for the use of molecular beacons in the GeneXpert MTB/ RIF assay. His personal income has been voluntarily and irrevocably capped at $5,000 per year and income to his laboratory has been voluntarily capped at $50,000 per year. All other authors: no reported conflicts.
Funding Information:
Financial support. This work was supported by the National Heart, Lung, and Blood Institute of the NIH (K23HL092629 to P. N.) and the Wellcome Trust, FIND, and Innovation For Health and Development (to C.A. E.).
Funding Information:
The recently developed Xpert MTB/RIF test (hereafter referred to as Xpert) on the GeneXpert platform (produced by Cepheid with support and funding from US federal agencies; the National Institutes of Health [NIH], National Institute of Allergy and Infectious Diseases [NIAID]; and the Foundation for Innovative and New Diagnostics [FIND], funded by the Bill & Melinda Gates Foundation) is an automated molecular-beacons-based approach to diagnosing M. tuberculosis and rifampin resistance [29, 30]. Molecular beacons are hybridization probes that, when attached to their target, emit fluorescence. The Xpert test has been shown to have high sensitivity and specificity for detection of M. tuberculosis and associated rifampin resistance in high-incidence settings, and plans are in place to pursue FDA approval for use of the test in the United States. Capable of providing results in less than 2 hours, Xpert may also reliably diagnose extrapulmonary tuberculosis [31]. Due to the automated, rapid, and sensitive nature of the test, Xpert has been endorsed by WHO and is to be rolled out as part of national plans for tuberculosis and MDR tuberculosis care and control [32]. A recent implementation of Xpert in South Africa highlighted the need for clinical pathways and algorithms for the optimal integration of the test into tuberculosis programs. For example, management of HIV-infected persons with suspected tuberculosis who test negative, among other clinical scenarios, warrants the study and institution of such algorithms.
PY - 2012/5/15
Y1 - 2012/5/15
N2 - The development, evaluation, and implementation of new and improved diagnostics have been identified as critical needs by human immunodeficiency virus (HIV) and tuberculosis researchers and clinicians alike. These needs exist in international and domestic settings and in adult and pediatric populations. Experts in tuberculosis and HIV care, researchers, healthcare providers, public health experts, and industry representatives, as well as representatives of pertinent US federal agencies (Centers for Disease Control and Prevention, Food and Drug Administration, National Institutes of Health, United States Agency for International Development) assembled at a workshop proposed by the Diagnostics Working Group of the Federal Tuberculosis Taskforce to review the state of tuberculosis diagnostics development in adult and pediatric populations.
AB - The development, evaluation, and implementation of new and improved diagnostics have been identified as critical needs by human immunodeficiency virus (HIV) and tuberculosis researchers and clinicians alike. These needs exist in international and domestic settings and in adult and pediatric populations. Experts in tuberculosis and HIV care, researchers, healthcare providers, public health experts, and industry representatives, as well as representatives of pertinent US federal agencies (Centers for Disease Control and Prevention, Food and Drug Administration, National Institutes of Health, United States Agency for International Development) assembled at a workshop proposed by the Diagnostics Working Group of the Federal Tuberculosis Taskforce to review the state of tuberculosis diagnostics development in adult and pediatric populations.
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U2 - 10.1093/infdis/jis194
DO - 10.1093/infdis/jis194
M3 - Review article
C2 - 22476718
AN - SCOPUS:84860358872
SN - 0022-1899
VL - 205
SP - S159-S168
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
IS - SUPPL. 2
ER -