Xpert TB diagnostic highlights gap in point-of-care pipeline

The Lancet Infectious Diseases (Impact Factor: 22.43). 11/2010; 10(11):742-3. DOI: 10.1016/S1473-3099(10)70231-0
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    • "Early reports on the Xpert MTB ⁄ RIF technology suggest that it was designed to be placed at patient-contact sites where nurses could provide treatment immediately upon diagnosis (Helb et al. 2010; Morris 2010; Boehme et al. 2011). Among the reasons for South Africa's decision to place the Xpert technology at laboratories rather than at point of treatment were concerns about both the cost of the test and of the required improvements to the peripheral health facilities, such as air conditioning and stable electricity supply (Trébucq et al. 2011; World Health Organization 2011b). "
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    ABSTRACT: Objective The World Health Organization recommends using Xpert MTB/RIF for diagnosis of pulmonary tuberculosis (PTB), but there is little evidence on the optimal placement of Xpert instruments in public health systems. We used recent South African data to compare the cost of placing Xpert at points of TB treatment (all primary clinics and hospitals) with the cost of placement at sub-district laboratories. Methods We estimated Xpert’s cost/test in a primary clinic pilot and in the pilot phase of the national Xpert roll-out to smear microscopy laboratories; the expected future volumes for each of 223 laboratories or 3799 points of treatment; the number and cost of Xpert instruments required and the national cost of using Xpert for PTB diagnosis for each placement scenario in 2014. Results In 2014, South Africa will test 2.6 million TB suspects. Laboratory placement requires 274 Xpert instruments, while point-of-treatment placement requires 4020 instruments. With an Xpert cartridge price of $14.00, the cost/test is $26.54 for laboratory placement and $38.91 for point-of-treatment placement. Low test volumes and a high number of sites are the major contributors to higher point-of-treatment costs. National placement of Xpert at laboratories would cost $71 million/year; point-of-treatment placement would cost $107 million/year, 51% more. Conclusion Placing Xpert technology at points of treatment is substantially more expensive than placing the instruments in smear microscopy laboratories. The incremental benefits of point-of-treatment placement, in terms of better patient outcomes, will have to be equally substantial to justify the additional cost to the national health budget.
    Tropical Medicine & International Health 06/2012; 17(9):1142-51. DOI:10.1111/j.1365-3156.2012.03028.x · 2.33 Impact Factor
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    ABSTRACT: Tuberculosis is unique among the major infectious diseases in that it lacks accurate rapid point-of-care diagnostic tests. Failure to control the spread of tuberculosis is largely due to our inability to detect and treat all infectious cases of pulmonary tuberculosis in a timely fashion, allowing continued Mycobacterium tuberculosis transmission within communities. Currently recommended gold-standard diagnostic tests for tuberculosis are laboratory based, and multiple investigations may be necessary over a period of weeks or months before a diagnosis is made. Several new diagnostic tests have recently become available for detecting active tuberculosis disease, screening for latent M. tuberculosis infection, and identifying drug-resistant strains of M. tuberculosis. However, progress toward a robust point-of-care test has been limited, and novel biomarker discovery remains challenging. In the absence of effective prevention strategies, high rates of early case detection and subsequent cure are required for global tuberculosis control. Early case detection is dependent on test accuracy, accessibility, cost, and complexity, but also depends on the political will and funder investment to deliver optimal, sustainable care to those worst affected by the tuberculosis and human immunodeficiency virus epidemics. This review highlights unanswered questions, challenges, recent advances, unresolved operational and technical issues, needs, and opportunities related to tuberculosis diagnostics.
    The Journal of Infectious Diseases 04/2012; 205 Suppl 2(suppl 2):S147-58. DOI:10.1093/infdis/jir860 · 6.00 Impact Factor
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    ABSTRACT: Point of care (POC) diagnostics are often hailed as having the potential to transform tuberculosis (TB) control efforts. However, POC testing is better conceptualized as a system of diagnosis and treatment, not simply a test that can provide rapid, deployable results. Economic evaluations may help decision makers allocate scarce resources for TB control, but evaluations of POC testing face unique challenges that include evaluating the full diagnostic system, incorporating implementation costs, translating diagnostic results into health and accounting for downstream treatment costs. For economic evaluations to reach their full potential as decision-making tools for POC testing in TB, these challenges must be understood and addressed.
    Expert Review of Pharmacoeconomics & Outcomes Research 06/2013; 13(3):313-25. DOI:10.1586/erp.13.27 · 1.67 Impact Factor
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