Target product profile of a molecular drug-susceptibility test for use in microscopy centers - PubMed (original) (raw)

Review

. 2015 Apr 1;211 Suppl 2(Suppl 2):S39-49.

doi: 10.1093/infdis/jiu682.

David Dolinger 2, Marco Schito 3, William Wells 4, Frank Cobelens 5, Madhukar Pai 6, Matteo Zignol 7, Daniela Maria Cirillo 8, David Alland 9, Martina Casenghi 10, Jim Gallarda 11, Catharina C Boehme 2, Mark D Perkins 2

Affiliations

Review

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

Claudia M Denkinger et al. J Infect Dis. 2015.

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.

© The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

PubMed Disclaimer

Figures

Figure 1.

Figure 1.

Tuberculosis Alliance pipeline. Reproduced with permission of the TB Alliance [13].

Similar articles

Cited by

References

    1. World Health Organization (WHO) Geneva: WHO; 2011. Global tuberculosis report 2011.
    1. World Health Organization. Geneva: WHO; 2014. Global strategy and targets for tuberculosis prevention, care and control after 2015.
    1. Schaaf HS, Shean K, Donald PR. Culture confirmed multidrug resistant tuberculosis: diagnostic delay, clinical features, and outcome. Arch Dis Child. 2003;88:1106–11. - PMC - PubMed
    1. Boehme CC, Nicol MP, Nabeta P, et al. Feasibility, diagnostic accuracy, and effectiveness of decentralised use of the Xpert MTB/RIF test for diagnosis of tuberculosis and multidrug resistance: a multicentre implementation study. Lancet. 2011;377:1495–505. - PMC - PubMed
    1. World Health Organization (WHO) Geneva: WHO; 2014. Companion handbook to the WHO guidelines for the programmatic management of drug-resistant tuberculosis. - PubMed

Publication types

MeSH terms

Substances

LinkOut - more resources