TY - JOUR
T1 - Guidance for Studies Evaluating the Accuracy of Rapid Tuberculosis Drug-Susceptibility Tests
AU - Georghiou, Sophia B.
AU - Schumacher, Samuel G.
AU - Rodwell, Timothy C.
AU - Colman, Rebecca E.
AU - Miotto, Paolo
AU - Gilpin, Christopher
AU - Ismail, Nazir
AU - Rodrigues, Camilla
AU - Warren, Rob
AU - Weyer, Karin
AU - Zignol, Matteo
AU - Arafah, Sonia
AU - Cirillo, Daniela Maria
AU - Denkinger, Claudia M.
PY - 2019/10/8
Y1 - 2019/10/8
N2 - The development and implementation of rapid molecular diagnostics for tuberculosis (TB) drug-susceptibility testing is critical to inform treatment of patients and to prevent the emergence and spread of resistance. Optimal trial planning for existing tests and those in development will be critical to rapidly gather the evidence necessary to inform World Health Organization review and to support potential policy recommendations. The evidence necessary includes an assessment of the performance for TB and resistance detection as well as an assessment of the operational characteristics of these platforms. The performance assessment should include analytical studies to confirm the limit of detection and assay ability to detect mutations conferring resistance across globally representative strains. The analytical evaluation is typically followed by multisite clinical evaluation studies to confirm diagnostic performance in sites and populations of intended use. This paper summarizes the considerations for the design of these analytical and clinical studies.
AB - The development and implementation of rapid molecular diagnostics for tuberculosis (TB) drug-susceptibility testing is critical to inform treatment of patients and to prevent the emergence and spread of resistance. Optimal trial planning for existing tests and those in development will be critical to rapidly gather the evidence necessary to inform World Health Organization review and to support potential policy recommendations. The evidence necessary includes an assessment of the performance for TB and resistance detection as well as an assessment of the operational characteristics of these platforms. The performance assessment should include analytical studies to confirm the limit of detection and assay ability to detect mutations conferring resistance across globally representative strains. The analytical evaluation is typically followed by multisite clinical evaluation studies to confirm diagnostic performance in sites and populations of intended use. This paper summarizes the considerations for the design of these analytical and clinical studies.
KW - diagnostics
KW - drug-susceptibility testing
KW - target product profile
KW - tuberculosis
KW - WHO End TB Strategy
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U2 - 10.1093/infdis/jiz106
DO - 10.1093/infdis/jiz106
M3 - Article
C2 - 31593599
AN - SCOPUS:85073078449
VL - 220
SP - S126-S135
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
SN - 0022-1899
ER -