Tuberculosis diagnostics: which target product profiles should be prioritised?

Kik, Sandra V.; Denkinger, Claudia M.; Casenghi, Martina; Vadnais, Caroline; Pai, Madhukar

doi:10.1183/09031936.00027714

Cited by 79 publications

(81 citation statements)

References 9 publications

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“…Such detailed “target product profiles” (TPPs) have been developed for a number of tropical infectious diseases, including malaria [94], tuberculosis [95], and helminthiases [96]. TPPs are typically constructed by convening experts from the scientific community, technical agencies, industry, implementation agencies, clinicians, and national programs to identify and then prioritize specific diagnostic gaps.…”

Section: Target Product Profiles For Enteric Fever and Ints Diagnosticsmentioning

confidence: 99%

Diagnostics for invasive Salmonella infections: Current challenges and future directions

Andrews

Ryan

2015

Vaccine

121

136

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Invasive Salmonellosis caused by Salmonella enterica serotype Typhi or Paratyphi A, B, C, or invasive non-typhoidal Salmonella serotypes, is an immensely important disease cluster for which reliable, rapid diagnostic tests are not available. Blood culture remains the gold standard but is insensitive, slow, and resource-intensive. Existing molecular diagnostics have poor sensitivity due to the low organism burden in bodily fluids. Commercially available serologic tests for typhoidal Salmonella have had limited sensitivity and specificity. In high burden, resource-limited settings, reliance on clinical diagnosis or inaccurate tests often results in frequent, unnecessary treatment, which contributes selective pressure for the emergence of antimicrobial resistance. This practice also results in inadequate therapy for other etiologies of acute febrile illnesses, including leptospirosis and rickettsial infections. A number of novel serologic, molecular, transcriptomic and metabolomic approaches to diagnostics are under development. Target product profiles that outline specific needs may focus development and investment, and establish benchmarks for accuracy, cost, speed, and portability of new diagnostics. Of note, a critical barrier to diagnostic assay rollout will be the low cost and low perceived harm of empiric therapy on behalf of providers and patients, which leaves few perceived incentives to utilize diagnostics. Approaches that align incentives with societal goals of limiting inappropriate antimicrobial use, such as subsidizing diagnostics, may be essential for stimulating development and uptake of such assays in resource-limited settings. New diagnostics for invasive Salmonellosis should be developed and deployed alongside diagnostics for alternative etiologies of acute febrile illnesses to improve targeted use of antibiotics.

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Section: Target Product Profiles For Enteric Fever and Ints Diagnosticsmentioning

confidence: 99%

Diagnostics for invasive Salmonella infections: Current challenges and future directions

Andrews

Ryan

2015

Vaccine

121

136

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“…' As a fully standardized treatment that is optimal for all patients is currently not available in order to minimize under, or over, treatment an easily measurable biomarker signature closely associated with successful cure is desirable. This remains an area of intensive work [77,92,93]. Related to this aim, it is worth noting that 'successfully treated' TB patients are one of the primary groups at risk of developing active TB again, with a risk of around 2000 per 100 000 person years [94].…”

Section: Potential Role Of Host-derived Biomarkers In Treatment Guidancementioning

confidence: 99%

Individualizing management of extensively drug-resistant tuberculosis: diagnostics, treatment, and biomarkers

Alffenaar

Akkerman

Anthony

et al. 2016

Expert Review of Anti-infective Therapy

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Introduction: Success rates for treatment of extensively drug resistant tuberculosis (XDR-TB) are low due to limited treatment options, delayed diagnosis and inadequate health care infrastructure. Areas covered: This review analyses existing programmes of prevention, diagnosis and treatment of XDR-TB. Improved diagnostic procedures and rapid molecular tests help to select appropriate drugs and dosages. Drugs dosages can be further tailored to the specific conditions of the patient based on quantitative susceptibility testing of the M. tuberculosis isolate and use of therapeutic drug monitoring. Pharmacovigilance is important for preserving activity of the novel drugs bedaquiline and delamanid. Furthermore, biomarkers of treatment response must be developed and validated to guide therapeutic decisions. Expert commentary: Given the currently poor treatment outcomes and the association of XDR-TB with HIV in endemic regions, a more patient oriented approach regarding diagnostics, drug selection and tailoring and treatment evaluation will improve treatment outcome. The different areas of expertise should be covered by a multidisciplinary team and may involve the transition of patients from hospitalized to home or community-based treatment.

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“…In the short term (the next 5 years), we need to expand the range of molecular technologies that can replace sputum smear microscopy at the primary care level, where most patients with suspected TB seek medical care [9]. However, since molecular assays are not suitable for treatment monitoring, smear microscopy may still have a role, until a better test for cure is identified.…”

Section: Who-endorsed Molecular Tb Testsmentioning

confidence: 99%

Molecular diagnosis of tuberculosis: we need solutions that span the healthcare value chain

MacLean

Huddart

Pai

2016

Expert Review of Molecular Diagnostics

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Tuberculosis diagnostics: which target product profiles should be prioritised?

Cited by 79 publications

References 9 publications

Diagnostics for invasive Salmonella infections: Current challenges and future directions

Diagnostics for invasive Salmonella infections: Current challenges and future directions

Individualizing management of extensively drug-resistant tuberculosis: diagnostics, treatment, and biomarkers

Molecular diagnosis of tuberculosis: we need solutions that span the healthcare value chain

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