Target product profile of a molecular drug-susceptibility test for use in microscopy centers.
J Infect Dis
; 211 Suppl 2: S39-49, 2015 Apr 01.
Article
em En
| MEDLINE
| ID: mdl-25765105
ABSTRACT
BACKGROUND:
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.METHODS:
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.RESULTS:
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.CONCLUSION:
This target product profile defines the needs as perceived by the tuberculosis stakeholder community and attempts to provide a means of communication with test developers to ensure that fit-for-purpose DSTs are being developed.Palavras-chave
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Tuberculose
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Testes de Sensibilidade Microbiana
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Técnicas de Diagnóstico Molecular
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Testes Diagnósticos de Rotina
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Antituberculosos
Tipo de estudo:
Diagnostic_studies
Limite:
Humans
Idioma:
En
Ano de publicação:
2015
Tipo de documento:
Article