Target Product Profile for a Diagnostic Assay to Differentiate between Bacterial and Non-Bacterial Infections and Reduce Antimicrobial Overuse in Resource-Limited Settings: An Expert Consensus
Acute fever is one of the most common presenting symptoms globally. In order to reduce the empiric use of antimicrobial drugs and improve outcomes, it is essential to improve diagnostic capabilities. In the absence of microbiology facilities in low-income settings, an assay to distinguish bacterial...
| Autores: | , , , , , , , , , , , , , , , |
|---|---|
| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2016 |
| País: | España |
| Institución: | Universidad de Barcelona |
| Repositorio: | Dipòsit Digital de la UB |
| OAI Identifier: | oai:diposit.ub.edu:2445/101575 |
| Acceso en línea: | https://hdl.handle.net/2445/101575 |
| Access Level: | acceso abierto |
| Palabra clave: | Malalties bacterianes Marcadors bioquímics Malària Bacterial diseases Biochemical markers Malaria |
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Target Product Profile for a Diagnostic Assay to Differentiate between Bacterial and Non-Bacterial Infections and Reduce Antimicrobial Overuse in Resource-Limited Settings: An Expert ConsensusDittrich, SabineTilahun, Birkneh TilahunMoussy, FrancisChua, ArleneZorzet, AnnaTängdén, ThomasDolinger, David L.Page, Anne-LaureCrump, John A.Acremont, Valerie D’Bassat Orellana, QuiqueLubell, YoelNewton, Paul N.Heinrich, NorbertRodwell, Timothy J.González, Iveth J.Malalties bacterianesMarcadors bioquímicsMalàriaBacterial diseasesBiochemical markersMalariaAcute fever is one of the most common presenting symptoms globally. In order to reduce the empiric use of antimicrobial drugs and improve outcomes, it is essential to improve diagnostic capabilities. In the absence of microbiology facilities in low-income settings, an assay to distinguish bacterial from non-bacterial causes would be a critical first step. To ensure that patient and market needs are met, the requirements of such a test should be specified in a target product profile (TPP). To identify minimal/optimal characteristics for a bacterial vs. non-bacterial fever test, experts from academia and international organizations with expertise in infectious diseases, diagnostic test development, laboratory medicine, global health, and health economics were convened. Proposed TPPs were reviewed by this working group, and consensus characteristics were defined. The working group defined non-severely ill, non-malaria infected children as the target population for the desired assay. To provide access to the most patients, the test should be deployable to community health centers and informal health settings, and staff should require <2 days of training to perform the assay. Further, given that the aim is to reduce inappropriate antimicrobial use as well as to deliver appropriate treatment for patients with bacterial infections, the group agreed on minimal diagnostic performance requirements of >90% and >80% for sensitivity and specificity, respectively. Other key characteristics, to account for the challenging environment at which the test is targeted, included: i) time-to-result <10 min (but maximally <2 hrs); ii) storage conditions at 0–40°C, ≤90% non-condensing humidity with a minimal shelf life of 12 months; iii) operational conditions of 5–40°C, ≤90% non-condensing humidity; and iv) minimal sample collection needs (50–100μL, capillary blood). This expert approach to define assay requirements for a bacterial vs. non-bacterial assay should guide product development, and enable targeted and timely efforts by industry partners and academic institutions.Public Library of Science (PLoS)2016info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/2445/101575Articles publicats en revistes (ISGlobal)reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésReproducció del document publicat a: http://dx.doi.org/10.1371/journal.pone.0161721PLoS One, 2016, vol. 11, num. 8, p. e0161721http://dx.doi.org/10.1371/journal.pone.0161721cc by (c) Dittrich et al., 2016http://creativecommons.org/licenses/by/3.0/es/info:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/1015752026-05-27T06:46:51Z |
| dc.title.none.fl_str_mv |
Target Product Profile for a Diagnostic Assay to Differentiate between Bacterial and Non-Bacterial Infections and Reduce Antimicrobial Overuse in Resource-Limited Settings: An Expert Consensus |
| title |
Target Product Profile for a Diagnostic Assay to Differentiate between Bacterial and Non-Bacterial Infections and Reduce Antimicrobial Overuse in Resource-Limited Settings: An Expert Consensus |
| spellingShingle |
Target Product Profile for a Diagnostic Assay to Differentiate between Bacterial and Non-Bacterial Infections and Reduce Antimicrobial Overuse in Resource-Limited Settings: An Expert Consensus Dittrich, Sabine Malalties bacterianes Marcadors bioquímics Malària Bacterial diseases Biochemical markers Malaria |
| title_short |
Target Product Profile for a Diagnostic Assay to Differentiate between Bacterial and Non-Bacterial Infections and Reduce Antimicrobial Overuse in Resource-Limited Settings: An Expert Consensus |
| title_full |
Target Product Profile for a Diagnostic Assay to Differentiate between Bacterial and Non-Bacterial Infections and Reduce Antimicrobial Overuse in Resource-Limited Settings: An Expert Consensus |
| title_fullStr |
Target Product Profile for a Diagnostic Assay to Differentiate between Bacterial and Non-Bacterial Infections and Reduce Antimicrobial Overuse in Resource-Limited Settings: An Expert Consensus |
| title_full_unstemmed |
Target Product Profile for a Diagnostic Assay to Differentiate between Bacterial and Non-Bacterial Infections and Reduce Antimicrobial Overuse in Resource-Limited Settings: An Expert Consensus |
| title_sort |
Target Product Profile for a Diagnostic Assay to Differentiate between Bacterial and Non-Bacterial Infections and Reduce Antimicrobial Overuse in Resource-Limited Settings: An Expert Consensus |
| dc.creator.none.fl_str_mv |
Dittrich, Sabine Tilahun, Birkneh Tilahun Moussy, Francis Chua, Arlene Zorzet, Anna Tängdén, Thomas Dolinger, David L. Page, Anne-Laure Crump, John A. Acremont, Valerie D’ Bassat Orellana, Quique Lubell, Yoel Newton, Paul N. Heinrich, Norbert Rodwell, Timothy J. González, Iveth J. |
| author |
Dittrich, Sabine |
| author_facet |
Dittrich, Sabine Tilahun, Birkneh Tilahun Moussy, Francis Chua, Arlene Zorzet, Anna Tängdén, Thomas Dolinger, David L. Page, Anne-Laure Crump, John A. Acremont, Valerie D’ Bassat Orellana, Quique Lubell, Yoel Newton, Paul N. Heinrich, Norbert Rodwell, Timothy J. González, Iveth J. |
| author_role |
author |
| author2 |
Tilahun, Birkneh Tilahun Moussy, Francis Chua, Arlene Zorzet, Anna Tängdén, Thomas Dolinger, David L. Page, Anne-Laure Crump, John A. Acremont, Valerie D’ Bassat Orellana, Quique Lubell, Yoel Newton, Paul N. Heinrich, Norbert Rodwell, Timothy J. González, Iveth J. |
| author2_role |
author author author author author author author author author author author author author author author |
| dc.subject.none.fl_str_mv |
Malalties bacterianes Marcadors bioquímics Malària Bacterial diseases Biochemical markers Malaria |
| topic |
Malalties bacterianes Marcadors bioquímics Malària Bacterial diseases Biochemical markers Malaria |
| description |
Acute fever is one of the most common presenting symptoms globally. In order to reduce the empiric use of antimicrobial drugs and improve outcomes, it is essential to improve diagnostic capabilities. In the absence of microbiology facilities in low-income settings, an assay to distinguish bacterial from non-bacterial causes would be a critical first step. To ensure that patient and market needs are met, the requirements of such a test should be specified in a target product profile (TPP). To identify minimal/optimal characteristics for a bacterial vs. non-bacterial fever test, experts from academia and international organizations with expertise in infectious diseases, diagnostic test development, laboratory medicine, global health, and health economics were convened. Proposed TPPs were reviewed by this working group, and consensus characteristics were defined. The working group defined non-severely ill, non-malaria infected children as the target population for the desired assay. To provide access to the most patients, the test should be deployable to community health centers and informal health settings, and staff should require <2 days of training to perform the assay. Further, given that the aim is to reduce inappropriate antimicrobial use as well as to deliver appropriate treatment for patients with bacterial infections, the group agreed on minimal diagnostic performance requirements of >90% and >80% for sensitivity and specificity, respectively. Other key characteristics, to account for the challenging environment at which the test is targeted, included: i) time-to-result <10 min (but maximally <2 hrs); ii) storage conditions at 0–40°C, ≤90% non-condensing humidity with a minimal shelf life of 12 months; iii) operational conditions of 5–40°C, ≤90% non-condensing humidity; and iv) minimal sample collection needs (50–100μL, capillary blood). This expert approach to define assay requirements for a bacterial vs. non-bacterial assay should guide product development, and enable targeted and timely efforts by industry partners and academic institutions. |
| publishDate |
2016 |
| dc.date.none.fl_str_mv |
2016 |
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info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
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article |
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publishedVersion |
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https://hdl.handle.net/2445/101575 |
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https://hdl.handle.net/2445/101575 |
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Inglés |
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Inglés |
| dc.relation.none.fl_str_mv |
Reproducció del document publicat a: http://dx.doi.org/10.1371/journal.pone.0161721 PLoS One, 2016, vol. 11, num. 8, p. e0161721 http://dx.doi.org/10.1371/journal.pone.0161721 |
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cc by (c) Dittrich et al., 2016 http://creativecommons.org/licenses/by/3.0/es/ info:eu-repo/semantics/openAccess |
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cc by (c) Dittrich et al., 2016 http://creativecommons.org/licenses/by/3.0/es/ |
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Public Library of Science (PLoS) |
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Public Library of Science (PLoS) |
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Articles publicats en revistes (ISGlobal) reponame:Dipòsit Digital de la UB instname:Universidad de Barcelona |
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