Estimated clinical impact of the Xpert MTB/RIF Ultra cartridge for diagnosis of pulmonary tuberculosis: A modeling study

1. Boehme CC, Nicol MP, Nabeta P, Michael JS, Gotuzzo E, Tahirli R, et al. Feasibility, diagnostic accuracy, and effectiveness of decentralised use of the Xpert MTB/RIF test for diagnosis of tuberculosis and multidrug resistance: a multicentre implementation study. Lancet. 2011;377(9776):1495–505. doi: 10.1016/S0140-6736(11)60438-8 21507477

2. Steingart KR, Schiller I, Horne DJ, Pai M, Boehme CC, Dendukuri N. Xpert® MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in adults. Cochrane Database Syst Rev. 2014;(1):CD009593. doi: 10.1002/14651858.CD009593.pub3 24448973

3. Lawn SD, Mwaba P, Bates M, Piatek A, Alexander H, Marais BJ, et al. Advances in tuberculosis diagnostics: the Xpert MTB/RIF assay and future prospects for a point-of-care test. Lancet Infect Dis. 2013;13(4):349–61. doi: 10.1016/S1473-3099(13)70008-2 23531388

4. Alland D, Rowneki M, Smith L, Ryan J, Chancellor M, Simmons AM, et al. Xpert MTB/RIF Ultra: a new near-patient TB test with sensitivity equal to culture. Conference on Retroviruses and Opportunistic Infections; 2015 Feb 23–26; Seattle, WA, US.

5. Dorman SE, Schumacher SG, Alland D, Nabeta P, Armstrong DT, King B, et al. Xpert MTB/RIF Ultra for detection of Mycobacterium tuberculosis and rifampin resistance: a multicentre diagnostic accuracy study. Lancet Infect Dis [Internet]. 2017 Nov 30 [cited 2017 Dec 1]. Available from: http://dx.doi.org/10.1016/S1473-3099(17)30691-6.

6. World Health Organization. WHO meeting report of a technical expert consultation: non-inferiority analysis of Xpert MTB/RIF Ultra compared to Xpert MTB/RIF. Geneva: World Health Organization; 2017 [cited 2017 Mar 24]. Available from: http://www.who.int/tb/publications/2017/XpertUltra/en/.

7. FIND. Negotiated product pricing. Geneva: FIND; 2017 [cited 2017 Nov 13]. Available from: https://www.finddx.org/find-negotiated-product-pricing/.

8. South Africa National Health Laboratory Service. GeneXpert MTB/RIF: progress report. Johannesburg: South Africa National Health Laboratory Service; 2017 Mar [cited 2017 Oct 12]. Available from: http://www.nhls.ac.za/assets/files/GeneXpert%20National%20Report%20March%202017.pdf.

9. World Health Organization. Tuberculosis (TB): WHO TB burden estimates. Geneva: World Health Organization; 2015 [cited 2015 May 20]. Available from: http://www.who.int/tb/country/data/download/en/.

10. World Health Organization. Global tuberculosis report 2016. Geneva: World Health Organization; 2016 [cited 2016 Oct 27]. Available from: http://apps.who.int/iris/bitstream/10665/250441/1/9789241565394-eng.pdf.

11. Sachdeva KS, Raizada N, Gupta RS, Nair SA, Denkinger C, Paramasivan CN, et al. The potential impact of up-front drug sensitivity testing on India’s epidemic of multi-drug resistant tuberculosis. PLoS ONE. 2015;10(7):e0131438. doi: 10.1371/journal.pone.0131438 26132584

12. Shah SK, Kumar AMV, Dogar OF, Khan MA, Qadeer E, Tahseen S, et al. Xpert® MTB/RIF under routine conditions in diagnosing pulmonary tuberculosis: a study in two hospitals in Pakistan. Public Health Action. 2013;3(1):20–2. doi: 10.5588/pha.12.0081 26392990

13. Hanrahan CF, Clouse K, Bassett J, Mutunga L, Selibas K, Stevens W, et al. The patient impact of point-of-care vs. laboratory placement of Xpert(®) MTB/RIF. Int J Tuberc Lung Dis. 2015;19(7):811–6. doi: 10.5588/ijtld.15.0013 26056107

14. Hanrahan CF, Haguma P, Ochom E, Kinera I, Cobelens F, Cattamanchi A, et al. Implementation of Xpert MTB/RIF in Uganda: missed opportunities to improve diagnosis of tuberculosis. Open Forum Infect Dis. 2016;3(2):ofw068. doi: 10.1093/ofid/ofw068 27186589

15. Lan N, Lademarco MF, Binkin NJ, Tung LB, Quy HT, Cĵ NV. A case series: initial outcome of persons with multidrug-resistant tuberculosis after treatment with the WHO standard retreatment regimen in Ho Chi Minh City, Vietnam. Int J Tuberc Lung Dis. 2001;5(6):575–8. 11409587

16. He GX, Xie YG, Wang LX, Borgdorff MW, van der Werf MJ, Fan JH, et al. Follow-up of patients with multidrug resistant tuberculosis four years after standardized first-line drug treatment. PLoS ONE. 2010;5(5):e10799. doi: 10.1371/journal.pone.0010799 20520720

17. World Health Organization. WHO treatment guidelines for drug-resistant tuberculosis: 2016 update. Geneva: World Health Organization; 2016 [cited 2016 Jul 13]. Available from: http://www.who.int/tb/areas-of-work/drug-resistant-tb/treatment/resources/en/.

18. Menzies D, Benedetti A, Paydar A, Martin I, Royce S, Pai M, et al. Effect of duration and intermittency of rifampin on tuberculosis treatment outcomes: a systematic review and meta-analysis. PLoS Med. 2009;6(9):e1000146. doi: 10.1371/journal.pmed.1000146 19753109

19. Li J, Munsiff SS, Driver CR, Sackoff J. Relapse and acquired rifampin resistance in HIV-infected patients with tuberculosis treated with rifampin- or rifabutin-based regimens in New York City, 1997–2000. Clin Infect Dis. 2005;41(1):83–91. doi: 10.1086/430377 15937767

20. Aung KJM, Van Deun A, Declercq E, Sarker MR, Das PK, Hossain MA, et al. Successful “9-month Bangladesh regimen” for multidrug-resistant tuberculosis among over 500 consecutive patients. Int J Tuberc Lung Dis. 2014;18(10):1180–7. doi: 10.5588/ijtld.14.0100 25216831

21. R Core Team. R: a language and environment for statistical computing. Version 3.2.2. Vienna: R Foundation for Statistical Computing; 2014. Available from: http://www.R-project.org/.

22. Zhou C, Long Q, Chen J, Xiang L, Li Q, Tang S, et al. Factors that determine catastrophic expenditure for tuberculosis care: a patient survey in China. Infect Dis Poverty. 2016;5:6. doi: 10.1186/s40249-016-0100-6 26806552

23. Moreira J, Bisig B, Muwawenimana P, Basinga P, Bisoffi Z, Haegeman F, et al. Weighing harm in therapeutic decisions of smear-negative pulmonary tuberculosis. Med Decis Making. 2009;29(3):380–90. doi: 10.1177/0272989X08327330 19224870

24. Zar H, Workman L, Nicol M. Diagnosis of pulmonary tuberculosis in HIV-infected and uninfected children using Xpert MTB/RIF Ultra. Am J Respir Crit Care Med. 2017;195:A7610.

25. Bahr NC, Nuwagira E, Evans EE, Cresswell FV, Bystrom PV, Byamukama A, et al. Diagnostic accuracy of Xpert MTB/RIF Ultra for tuberculous meningitis in HIV-infected adults: a prospective cohort study. Lancet Infect Dis. 2017 Sep 14. doi: 10.1016/S1473-3099(17)30474-7

26. Chakravorty S, Simmons AM, Rowneki M, Parmar H, Cao Y, Ryan J, et al. The new Xpert MTB/RIF Ultra: improving detection of Mycobacterium tuberculosis and resistance to rifampin in an assay suitable for point-of-care testing. mBio. 2017;8(4):e00812–17. doi: 10.1128/mBio.00812-17 28851844

27. Dye C, Bassili A, Bierrenbach AL, Broekmans JF, Chadha VK, Glaziou P, et al. Measuring tuberculosis burden, trends, and the impact of control programmes. Lancet Infect Dis. 2008;8(4):233–43. doi: 10.1016/S1473-3099(07)70291-8 18201929

28. Behr MA, Warren SA, Salamon H, Hopewell PC, Ponce de Leon A, Daley CL, et al. Transmission of Mycobacterium tuberculosis from patients smear-negative for acid-fast bacilli. Lancet. 1999;353(9151):444–9. 9989714

29. Menzies NA, Cohen T, Lin H-H, Murray M, Salomon JA. Population health impact and cost-effectiveness of tuberculosis diagnosis with Xpert MTB/RIF: a dynamic simulation and economic evaluation. PLoS Med. 2012;9(11):e1001347. doi: 10.1371/journal.pmed.1001347 23185139

30. Durovni B, Saraceni V, van den Hof S, Trajman A, Cordeiro-Santos M, Cavalcante S, et al. Impact of replacing smear microscopy with Xpert MTB/RIF for diagnosing tuberculosis in Brazil: a stepped-wedge cluster-randomized trial. PLoS Med. 2014;11(12):e1001766. doi: 10.1371/journal.pmed.1001766 25490549

31. Harries AD, Ade S, Burney P, Hoa NB, Schluger NW, Castro JL. Successfully treated but not fit for purpose: paying attention to chronic lung impairment after TB treatment. Int J Tuberc Lung Dis. 2016;20(8):1010–4. doi: 10.5588/ijtld.16.0277 27393532

32. GBD 2015 Mortality and Causes of Death Collaborators. Global, regional, and national life expectancy, all-cause mortality, and cause-specific mortality for 249 causes of death, 1980–2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016;388(10053):1459–544. doi: 10.1016/S0140-6736(16)31012-1 27733281

33. Vos T, Allen C, Arora M, Barber RM, Bhutta ZA, Brown A, et al. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016;388(10053):1545–602. doi: 10.1016/S0140-6736(16)31678-6 27733282

34. Menzies NA, Gomez GB, Bozzani F, Chatterjee S, Foster N, Baena IG, et al. Cost-effectiveness and resource implications of aggressive action on tuberculosis in China, India, and South Africa: a combined analysis of nine models. Lancet Glob Health. 2016;4(11):e816–26. doi: 10.1016/S2214-109X(16)30265-0 27720689

35. Denkinger CM, Schumacher SG, Boehme CC, Dendukuri N, Pai M, Steingart KR. Xpert MTB/RIF assay for the diagnosis of extrapulmonary tuberculosis: a systematic review and meta-analysis. Eur Respir J. 2014;44(2):435–46. doi: 10.1183/09031936.00007814 24696113

36. Detjen AK, DiNardo AR, Leyden J, Steingart KR, Menzies D, Schiller I, et al. Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis in children: a systematic review and meta-analysis. Lancet Respir Med. 2015;3(6):451–61. doi: 10.1016/S2213-2600(15)00095-8 25812968