Abstract
To accelerate the fight against tuberculosis, major diagnostic challenges need to be addressed urgently. Post-2015 targets are unlikely to be met without the use of novel diagnostics that are more accurate and can be used closer to where patients first seek care in affordable diagnostic algorithms. This article describes the efforts by the stakeholder community that led to the identification of the high-priority diagnostic needs in tuberculosis. Subsequently target product profiles for the high-priority diagnostic needs were developed and reviewed in a World Health Organization (WHO)-led consensus meeting. The high-priority diagnostic needs included (1) a sputum-based replacement test for smear-microscopy; (2) a non-sputum-based biomarker test for all forms of tuberculosis, ideally suitable for use at levels below microscopy centers; (3) a simple, low cost triage test for use by first-contact care providers as a rule-out test, ideally suitable for use by community health workers; and (4) a rapid drug susceptibility test for use at the microscopy center level. The developed target product profiles, along with complimentary work presented in this supplement, will help to facilitate the interaction between the tuberculosis community and the diagnostics industry with the goal to lead the way toward the post-2015 global tuberculosis targets.
| Original language | English |
|---|---|
| Pages (from-to) | S29-S38 |
| Journal | Journal of Infectious Diseases |
| Volume | 211 |
| DOIs | |
| Publication status | Published - Apr 1 2015 |
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Keywords
- diagnosis
- point-of-care
- prioritization
- target product profiles
- tuberculosis
ASJC Scopus subject areas
- Medicine(all)
Cite this
Defining the needs for next generation assays for tuberculosis. / Denkinger, Claudia M.; Kik, Sandra V.; Cirillo, Daniela M aria; Casenghi, Martina; Shinnick, Thomas; Weyer, Karin; Gilpin, Chris; Boehme, Catharina C.; Schito, Marco; Kimerling, Michael; Pai, Madhukar.
In: Journal of Infectious Diseases, Vol. 211, 01.04.2015, p. S29-S38.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Defining the needs for next generation assays for tuberculosis
AU - Denkinger, Claudia M.
AU - Kik, Sandra V.
AU - Cirillo, Daniela M aria
AU - Casenghi, Martina
AU - Shinnick, Thomas
AU - Weyer, Karin
AU - Gilpin, Chris
AU - Boehme, Catharina C.
AU - Schito, Marco
AU - Kimerling, Michael
AU - Pai, Madhukar
PY - 2015/4/1
Y1 - 2015/4/1
N2 - To accelerate the fight against tuberculosis, major diagnostic challenges need to be addressed urgently. Post-2015 targets are unlikely to be met without the use of novel diagnostics that are more accurate and can be used closer to where patients first seek care in affordable diagnostic algorithms. This article describes the efforts by the stakeholder community that led to the identification of the high-priority diagnostic needs in tuberculosis. Subsequently target product profiles for the high-priority diagnostic needs were developed and reviewed in a World Health Organization (WHO)-led consensus meeting. The high-priority diagnostic needs included (1) a sputum-based replacement test for smear-microscopy; (2) a non-sputum-based biomarker test for all forms of tuberculosis, ideally suitable for use at levels below microscopy centers; (3) a simple, low cost triage test for use by first-contact care providers as a rule-out test, ideally suitable for use by community health workers; and (4) a rapid drug susceptibility test for use at the microscopy center level. The developed target product profiles, along with complimentary work presented in this supplement, will help to facilitate the interaction between the tuberculosis community and the diagnostics industry with the goal to lead the way toward the post-2015 global tuberculosis targets.
AB - To accelerate the fight against tuberculosis, major diagnostic challenges need to be addressed urgently. Post-2015 targets are unlikely to be met without the use of novel diagnostics that are more accurate and can be used closer to where patients first seek care in affordable diagnostic algorithms. This article describes the efforts by the stakeholder community that led to the identification of the high-priority diagnostic needs in tuberculosis. Subsequently target product profiles for the high-priority diagnostic needs were developed and reviewed in a World Health Organization (WHO)-led consensus meeting. The high-priority diagnostic needs included (1) a sputum-based replacement test for smear-microscopy; (2) a non-sputum-based biomarker test for all forms of tuberculosis, ideally suitable for use at levels below microscopy centers; (3) a simple, low cost triage test for use by first-contact care providers as a rule-out test, ideally suitable for use by community health workers; and (4) a rapid drug susceptibility test for use at the microscopy center level. The developed target product profiles, along with complimentary work presented in this supplement, will help to facilitate the interaction between the tuberculosis community and the diagnostics industry with the goal to lead the way toward the post-2015 global tuberculosis targets.
KW - diagnosis
KW - point-of-care
KW - prioritization
KW - target product profiles
KW - tuberculosis
UR - http://www.scopus.com/inward/record.url?scp=84929994231&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84929994231&partnerID=8YFLogxK
U2 - 10.1093/infdis/jiu821
DO - 10.1093/infdis/jiu821
M3 - Article
C2 - 25765104
AN - SCOPUS:84929994231
VL - 211
SP - S29-S38
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
SN - 0022-1899
ER -