Cost-effectiveness of novel algorithms for rapid diagnosis of tuberculosis in HIV-infected individuals in Uganda

Shah, Maunank; Dowdy, David W.; Joloba, Moses; Ssengooba, Willy; Manabe, Yukari C.; Ellner, Jerrold J.; Dorman, Susan E.

doi:10.1097/qad.0000000000000008

Cited by 38 publications

(43 citation statements)

References 29 publications

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“…Resistance testing would be an added advantage of urine TB PCR over urine LAM, despite the quadrupled cost, if leveraged on the existing Xpert platform. 26 The higher sensitivity of urine TB PCR in sputum microscopy-positive than in Author Manuscript sputum microscopy-negative patients (53% vs. 46%) in this review has also been observed in sputum Xpert, with a sensitivity of 98% in smear-positive patients and 67% in smearnegative patients. 27 We noted technical characteristics involving urine specimen handling that reveal opportunities for biotechnological optimization of the assay.…”

Section: Discussionmentioning

confidence: 89%

Diagnostic accuracy of nucleic acid amplification tests in urine for pulmonary tuberculosis: A meta-analysis

2015

Indian Journal of Tuberculosis

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OBJECTIVE-To determine the diagnostic accuracy of tuberculosis (TB) nucleic acid amplification tests (NAATs) in urine samples for individuals with active pulmonary tuberculosis (PTB).DESIGN-Systematic review and meta-analysis. Electronic databases and reference lists were searched without age or setting restrictions up to May 2015. Eligible articles examined Mycobacterium tuberculosis NAATs in urine samples for PTB diagnosis in patients with sputum culture as the reference standard, and reported sufficient data to separately calculate sensitivity or specificity.RESULTS-Eight studies, including 1212 participants from seven countries with a mean age ranging from 28 to 48 years, were included. Polymerase chain reaction (PCR) with insertion sequence (IS) 6110, rpoB or cfp32/hf6 as gene targets was used for NAATs. The pooled sensitivity and specificity was respectively 0.55 (95%CI 0.36-0.72) and 0.94 (95%CI 0.78-0.99), with slightly higher sensitivity in human immunodeficiency virus positive individuals, at 0.59 (95%CI 0.20-0.89). Sensitivity was higher in sputum microscopy-positive than -negative individuals. Storage temperatures below −70°C, centrifuge speed <5000 rpm and IS6110 increased sensitivity on meta-regression.Correspondence to: Diana Marangu, Department of Paediatrics and Child Health, University of Nairobi, P O Box 19676 -0202, Nairobi, Kenya. marangud@gmail.com. Conflicts of interest: none declared. HHS Public Access KeywordsNAAT; PCR; systematic review; meta-regression In 2013, it was estimated that there were 9 million incident tuberculosis (TB) cases globally, 3.3 million of whom were not diagnosed. 1 Urine nucleic acid amplification tests (NAATs) have potential for use in the diagnosis of pulmonary tuberculosis (PTB), the most common form of TB worldwide. [2][3][4] The relative simplicity of urine collection could be ideal to address diagnostic challenges of active PTB, 5 and could be exploited in point-of-care (POC) testing of active PTB at all levels of health care, and potentially in households and the community. 6,7 In addition to being safer to handle, normal urine production yields frequent and relatively large amounts, making urine specimens convenient to obtain and easier to test in comparison to sputum. Children could benefit the most from urine NAATs for PTB diagnosis due to challenges in obtaining sputum samples, particularly from young children who cannot expectorate, and the paucibacillary nature of their disease. 5,8 With the advancement of molecular techniques and wider use of the NAAT Xpert ® MTB/RIF assay (Cepheid, Sunnyvale, CA, USA) in many high TB endemic countries, exploration of alternative samples such as urine for TB diagnosis is increasing due to its ease of collection and potential for decentralized implementation. 9,10 Cell-free nucleic acids released from dying human cells and Mycobacterium tuberculosis microorganisms may be filtered through the kidneys, resulting in the detection of trans-renal DNA fragments in urine. 6 Although the exact pathophysiological mech...

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Section: Discussionmentioning

confidence: 89%

Diagnostic accuracy of nucleic acid amplification tests in urine for pulmonary tuberculosis: A meta-analysis

2015

Indian Journal of Tuberculosis

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“…Culture techniques also require significant laboratory infrastructure, as well as skilled personnel, and are prohibitively costly for most low-income settings. Costs range from US$12 to 35 per test in addition to capital costs associated with laboratory construction [12,13]. Consequently, culture is largely unavailable globally [11,12] – among the high burden TB countries, the majority have two or fewer laboratories in the entire country [1].…”

Section: State Of Current Tb Diagnostics Gaps Costs and Needsmentioning

confidence: 99%

“…Costs range from US$12 to 35 per test in addition to capital costs associated with laboratory construction [12,13]. Consequently, culture is largely unavailable globally [11,12] – among the high burden TB countries, the majority have two or fewer laboratories in the entire country [1]. While efforts are being made to identify faster culture methods, the inherently slow mycobacterial replication time and need for strong laboratory infrastructure preclude this strategy from being economically appealing for most test developers.…”

Section: State Of Current Tb Diagnostics Gaps Costs and Needsmentioning

confidence: 99%

“…The test performs best in HIV-infected patients with advanced immunosuppression, the group most likely to have disseminated TB disease and presence of antigen in urine [45,46]. The sensitivity in HIV-infected individuals ranges between 30 and 70%, and the test appears to be complementary to sputum testing by conventional diagnostics [12,47]. Perhaps, more importantly for the TB diagnostic, landscape is the proof of principle that disseminated forms of TB may be detectable through antigen detection in a cheap, affordable test format that is easily scalable.…”

Section: State Of Current Tb Diagnostics Gaps Costs and Needsmentioning

confidence: 99%

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Economic challenges associated with tuberculosis diagnostic development

Hanrahan

Shah²

2014

Expert Review of Pharmacoeconomics & Outcomes Research

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Tuberculosis remains a global health crisis in part due to underdiagnosis. Technological innovations are needed to improve diagnostic test accuracy and reduce the reliance on expensive laboratory infrastructure. However, there are significant economic challenges impeding the development and implementation of new diagnostics. The aim of this piece is to examine the current state of TB diagnostics, outline the unmet needs for new tests, and detail the economic challenges associated with development of new tests from the perspective of developers, policy makers and implementers.

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“…The urinary LAM assays currently available are unsuitable as general diagnostic or screening tests for TB, due to suboptimal sensitivity. The test was found to be cost-effective in subSaharan Africa when used for HIV-positive patients with CD4 counts of less than 100 per mm 3 [66], but lacks accuracy if used in patients with CD4 counts over 200 or in children.…”

Section: Advanced Diagnostic Techniquesmentioning

confidence: 99%

The Impact of Tuberculosis among Immigrants: Epidemiology and Strategies of Control in High-Income Countries—Current Data and Literature Review

Contini¹,

Maritati²,

Nuzzo³

et al. 2017

People's Movements in the 21st Century - Risks, Challenges and Benefits

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A significant reappearance of tuberculosis (TB) was observed in industrialized countries during the last two decades. This is due to the spread of HIV infection itself and to today's migratory phenomenon as a consequence of wealth disparity, poverty, wars and political persecutions. This proportion is expected to increase and represents an important cause of the overall resurgence of the TB epidemic and drug-resistant TB in Western Europe and the USA. TB is currently one of the leading causes of death worldwide and a health problem in high-income countries. Although WHO global TB report 2015 with its "STOP TB" strategy has the goal to eliminate TB as a public health problem by 2050, TB shows no signs of disappearing despite some decline in high-income countries. In order to intensify the fights against this deadly disease, further efforts should be aimed to improve examination/detection processes to accurately determine all kinds of TB, and how best to enhance TB control through a coordinated medical screening program of migrants for active TB. Migration in itself is not a definitive risk for TB. Stressful living condition, social isolation, poverty, political fear/persecution, and difficulties to access to health care can expose these individuals to the risk of TB infection during and after the migration process. This chapter aims to discuss and highlight all these issues.

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Cost-effectiveness of novel algorithms for rapid diagnosis of tuberculosis in HIV-infected individuals in Uganda

Cited by 38 publications

References 29 publications

Diagnostic accuracy of nucleic acid amplification tests in urine for pulmonary tuberculosis: A meta-analysis

Diagnostic accuracy of nucleic acid amplification tests in urine for pulmonary tuberculosis: A meta-analysis

Economic challenges associated with tuberculosis diagnostic development

The Impact of Tuberculosis among Immigrants: Epidemiology and Strategies of Control in High-Income Countries—Current Data and Literature Review

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