Expanding the role of diagnostic and prognostic tools for infectious diseases in resource-poor settings

Ghani, Azra C.; Burgess, Deborah Hay; Reynolds, Alison; Rousseau, Christine

doi:10.1038/nature16038

Cited by 32 publications

(31 citation statements)

References 10 publications

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“…When designing new diagnostic tests, the level of the healthcare system where a test will be deployed is an important consideration. Ghani et al have identified five healthcare system levels, with different types of diagnostic or prognostic tools suitable for different levels 31. Typhoid is most prevalent in LMIC with limited healthcare resources, and in these contexts the optimal typhoid test would not require sophisticated equipment and could be easily interpreted by non-laboratory personnel 6 7.…”

Section: Resultsmentioning

confidence: 99%

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

et al. 2019

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IntroductionTyphoid 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.MethodsA 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.ResultsA 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

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Section: Resultsmentioning

confidence: 99%

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

et al. 2019

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“…The US Centres for Disease Control and Prevention (CDC) has developed a convenient means of external quality assurance by working with countries to generate thermally stable proficiency panels that can be shipped to every POC testing site to ensure competence of testing personnel. However, a study in South Africa found that only 3% of HIV RDTs were performed correctly 15 . Although not every error will result in an incorrect diagnosis, the alarming reality is that with 150 million tests being performed annually worldwide, assuming a 99% accuracy rate, as many as 1.5 million incorrect results per year could potentially be generated.…”

Section: Assured Diagnostic Testsmentioning

confidence: 99%

“…Assuring the quality of tests and testing is the biggest challenge when testing is decentralized at POC. There are many rapid tests from various manufacturers available, and test quality may impact accurate and inconsistent diagnosis across different sites, with studies showing that high rates of errors were observed even in performance of simple RDTs for HIV and malaria 15,68 . Quality of testing requires proficiency panels be sent to all the POC testing sites by a national reference laboratory.…”

Section: Factors Associated With Successful Assured Diagnosticsmentioning

confidence: 99%

REASSURED diagnostics to inform disease control strategies, strengthen health systems and improve patient outcomes

et al. 2018

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“…As part of a wider initiative lead by Médecins Sans Frontières (MSF), the WHO, and the Foundation of Innovative New Diagnostics (FIND), the parameters of a multi-pathogen and multi-analyte diagnostic platform (MAPDx) to support improved diagnostic capacity at level 2 or above [21,22] were defined. This work aimed to prioritize common fever-causing pathogens to inform pathogens for use on a fever-specific diagnostic cartridge for diagnosis in LMICs using a two-pronged approach combining a) currently available scientific data incorporated into an analytical hierarchy process (AHP), and b) systematically gathered expert input to compensate for the paucity of regional and global pathogen-specific data availability.…”

Section: Introductionmentioning

confidence: 99%

Prioritising pathogens for the management of severe febrile patients to improve clinical care in low- and middle-income countries

et al. 2020

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Background: Severe febrile illness without a known source (SFWS) is a challenge for clinicians when deciding how to manage a patient, particularly given the wide spectrum of potential aetiologies that contribute to fever. These infections are difficult to distinguish clinically, and accurate diagnosis requires a plethora of diagnostics including blood cultures, imaging techniques, molecular or serological tests, and more. When laboratory services are available, a limited test menu hinders clinical decision-making and antimicrobial stewardship, leading to empiric treatment and suboptimal patient outcomes. To specifically address SFWS, this work aimed to identify priority pathogens for a globally applicable panel for fever causing pathogens. Method: A pragmatic two-pronged approach combining currently available scientific data in an analytical hierarchy process and systematically gathered expert input, was designed to address the lack of comprehensive global aetiology data. The expert re-ranked list was then further adapted for a specific use case to focus on community acquired infections in whole blood specimens. The resulting list was further analysed to address different geographical regions (Asia, Africa, and Latin America), and Cohen kappa scores of agreement were calculated. Results: The expert ranked prioritized pathogen list generated as part of this two-pronged approach included typhoidal Salmonella, Plasmodium species and Mycobacterium tuberculosis as the top 3 pathogens. This pathogen list was then further adapted for the SFWS use case to develop a final pathogen list to inform product development. Subsequent analysis comparing the relevance of the SFWS pathogen list to multiple populations and geographical regions showed that the SFWS prioritized list had considerable utility across Africa and Asia, but less so for Latin America. In addition, the list showed high levels of agreement across different patient sub-populations, but lower relevance for neonates and symptomatic HIV patients. Conclusion: This work highlighted once again the challenges of prioritising in global health, but it also shows that taking a two-pronged approach, combining available prevalence data with expert input, can result in a broadly applicable priority list. This comprehensive utility is particularly important in the context of product development, where a sufficient market size is essential to achieve a sustainable commercialized diagnostic product to address SFWS.

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Expanding the role of diagnostic and prognostic tools for infectious diseases in resource-poor settings

Cited by 32 publications

References 10 publications

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

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

REASSURED diagnostics to inform disease control strategies, strengthen health systems and improve patient outcomes

Prioritising pathogens for the management of severe febrile patients to improve clinical care in low- and middle-income countries

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