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Redefining typhoid diagnosis: what would an improved test need to look like?

INTRODUCTION: Typhoid fever is one of the most common bacterial causes of acute febrile illness in the developing world, with an estimated 10.9 million new cases and 116.8 thousand deaths in 2017. Typhoid point-of-care (POC) diagnostic tests are widely used but have poor sensitivity and specificity,...

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Autores principales: Mather, Richard G, Hopkins, Heidi, Parry, Christopher M, Dittrich, Sabine
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6830052/
https://www.ncbi.nlm.nih.gov/pubmed/31749999
http://dx.doi.org/10.1136/bmjgh-2019-001831
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author Mather, Richard G
Hopkins, Heidi
Parry, Christopher M
Dittrich, Sabine
author_facet Mather, Richard G
Hopkins, Heidi
Parry, Christopher M
Dittrich, Sabine
author_sort Mather, Richard G
collection PubMed
description INTRODUCTION: Typhoid fever is one of the most common bacterial causes of acute febrile illness in the developing world, with an estimated 10.9 million new cases and 116.8 thousand deaths in 2017. Typhoid point-of-care (POC) diagnostic tests are widely used but have poor sensitivity and specificity, resulting in antibiotic overuse that has led to the emergence and spread of multidrug-resistant strains. With recent advances in typhoid surveillance and detection, this is the ideal time to produce a target product profile (TPP) that guides product development and ensure that a next-generation test meets the needs of users in the resource-limited settings where typhoid is endemic. METHODS: A structured literature review was conducted to develop a draft TPP for a next-generation typhoid diagnostic test with minimal and optimal desired characteristics for 36 test parameters. The TPP was refined using feedback collected from a Delphi survey of key stakeholders in clinical medicine, microbiology, diagnostics and public and global health. RESULTS: A next-generation typhoid diagnostic test should improve patient management through the diagnosis and treatment of infection with acute Salmonella enterica serovars Typhi or Paratyphi with a sensitivity ≥90% and specificity ≥95%. The test would ideally be used at the lowest level of the healthcare system in settings without a reliable power or water supply and provide results in <15 min at a cost of <US$1.00. CONCLUSION: This report outlines the first comprehensive TPP for typhoid fever and is intended to guide the development of a next-generation typhoid diagnostic test. An accurate POC test will reduce the morbidity and mortality of typhoid fever through rapid diagnosis and treatment and will have the greatest impact in reducing antimicrobial resistance if it is combined with diagnostics for other causes of acute febrile illness in a treatment algorithm.
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spelling pubmed-68300522019-11-20 Redefining typhoid diagnosis: what would an improved test need to look like? Mather, Richard G Hopkins, Heidi Parry, Christopher M Dittrich, Sabine BMJ Glob Health Research INTRODUCTION: Typhoid fever is one of the most common bacterial causes of acute febrile illness in the developing world, with an estimated 10.9 million new cases and 116.8 thousand deaths in 2017. Typhoid point-of-care (POC) diagnostic tests are widely used but have poor sensitivity and specificity, resulting in antibiotic overuse that has led to the emergence and spread of multidrug-resistant strains. With recent advances in typhoid surveillance and detection, this is the ideal time to produce a target product profile (TPP) that guides product development and ensure that a next-generation test meets the needs of users in the resource-limited settings where typhoid is endemic. METHODS: A structured literature review was conducted to develop a draft TPP for a next-generation typhoid diagnostic test with minimal and optimal desired characteristics for 36 test parameters. The TPP was refined using feedback collected from a Delphi survey of key stakeholders in clinical medicine, microbiology, diagnostics and public and global health. RESULTS: A next-generation typhoid diagnostic test should improve patient management through the diagnosis and treatment of infection with acute Salmonella enterica serovars Typhi or Paratyphi with a sensitivity ≥90% and specificity ≥95%. The test would ideally be used at the lowest level of the healthcare system in settings without a reliable power or water supply and provide results in <15 min at a cost of <US$1.00. CONCLUSION: This report outlines the first comprehensive TPP for typhoid fever and is intended to guide the development of a next-generation typhoid diagnostic test. An accurate POC test will reduce the morbidity and mortality of typhoid fever through rapid diagnosis and treatment and will have the greatest impact in reducing antimicrobial resistance if it is combined with diagnostics for other causes of acute febrile illness in a treatment algorithm. BMJ Publishing Group 2019-10-31 /pmc/articles/PMC6830052/ /pubmed/31749999 http://dx.doi.org/10.1136/bmjgh-2019-001831 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Research
Mather, Richard G
Hopkins, Heidi
Parry, Christopher M
Dittrich, Sabine
Redefining typhoid diagnosis: what would an improved test need to look like?
title Redefining typhoid diagnosis: what would an improved test need to look like?
title_full Redefining typhoid diagnosis: what would an improved test need to look like?
title_fullStr Redefining typhoid diagnosis: what would an improved test need to look like?
title_full_unstemmed Redefining typhoid diagnosis: what would an improved test need to look like?
title_short Redefining typhoid diagnosis: what would an improved test need to look like?
title_sort redefining typhoid diagnosis: what would an improved test need to look like?
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6830052/
https://www.ncbi.nlm.nih.gov/pubmed/31749999
http://dx.doi.org/10.1136/bmjgh-2019-001831
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