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J Infect Dis. 2015 Apr 1;211 Suppl 2:S39-49. doi: 10.1093/infdis/jiu682.

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

Author information

1
FIND Division of Infectious Disease, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
2
FIND.
3
Division of AIDS, Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, Maryland.
4
TB Alliance, New York, New York.
5
KNCV Tuberculosis Foundation, the Hague Amsterdam Institute for Global Health and Development, Academic Medical Center, Amsterdam, The Netherlands.
6
McGill International TB Centre Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Canada.
7
World Health Organization.
8
IRCCS San Raffaele Scientific Institute, Milan, Italy.
9
Rutgers University, New Brunswick, New Jersey.
10
Médecins sans Frontières, Geneva, Switzerland.
11
Bill and Melinda Gates Foundation, Seattle, Washington.

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.

KEYWORDS:

diagnostics; molecular testing; point of care; tuberculosis

PMID:
25765105
PMCID:
PMC4425821
DOI:
10.1093/infdis/jiu682
[Indexed for MEDLINE]
Free PMC Article

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