6.References

  1. Global tuberculosis report 2023. Geneva: World Health Organization; 2023 (https://www.who.int/publications/i/item/9789240083851).
  2. Impact of the COVID-19 pandemic on TB detection and mortality in 2020. . Geneva: World Health Organization; 2021 (https://www.who.int/publications/m/item/impact-of-the-covid-19-pandemic-on-tb-detection-and-mortality-in-2020).
  3. Global tuberculosis report 2020. Geneva: World Health Organization; 2020 (https://www.who.int/publications/i/item/9789240013131).
  4. Catalogue of mutations in Mycobacterium tuberculosis complex and their association with drug resistance, second edition. Geneva: World Health Organization; 2023 (https://www.who.int/publications/i/item/9789240082410).
  5. The End TB Strategy. Geneva: World Health Organization; 2015 (https://www.who.int/publications/i/item/WHO-HTM-TB-2015.19).
  6. WHO standard: universal access to rapid tuberculosis diagnostics. Geneva: World Health Organization; 2023 (https://www.who.int/publications/i/item/9789240071315).
  7. WHO consolidated guidelines on tuberculosis. Module 3: Diagnosis – rapid diagnostics for tuberculosis detection, 2021 update. Geneva: World Health Organization; 2021 (https://www.who.int/publications/i/item/9789240029415).
  8. Framework of indicators and targets for laboratory strengthening under the End TB Strategy (WHO/ HTM/TB/2016.18). Geneva: World Health Organization; 2016 (https://www.who.int/publications/i/ item/9789241511438).
  9. WHO consolidated guidelines on tuberculosis. Module 4: Treatment – drug-resistant tuberculosis treatment. Geneva: World Health Organization; 2022 (https://www.who.int/publications/i/item/ 9789240063129).
  10. Public announcement to TB in vitro diagnostics manufacturers. Geneva: World Health Organization; 2021 ((https://www.who.int/publications/m/item/public-announcement-to-tb-in-vitro-diagnostics-manufacturers).
  11. WHO operational handbook on tuberculosis. Module 3: Diagnosis – rapid diagnostics for tuberculosis detection, 2021 update. Geneva: World Health Organization; 2021 (https://www.who.int/publications/i/item/9789240030589).
  12. World Health Organization G. TB Knowledge Sharing – Training Catalogue [online training course] [website]. 2021 (https://tbksp.org/en/node/1722).
  13. WHO consolidated guidelines on tuberculosis. Module 3: Diagnosis – rapid diagnostics for tuberculosis detection, third edition. Geneva: World Health Organization; 2024 (https://iris.who.int/handle/10665/376221).
  14. Global Laboratory Initiative [website]. Global Laboratory Initiative; 2023 (https://www.stoptb.org/stop-tb-working-groups/global-laboratory-initiative-gli).
  15. Definitions and reporting framework for tuberculosis – 2013 revision (updated December 2014 and January 2020) (WHO/HTM/TB/2013.2). Geneva: World Health Organization; 2020 (https://www.who.int/publications/i/item/9789241505345).
  16. Practical guide to implementation of Truenat tests for the detection of TB and rifampicin resistance (Version 2). Geneva: Stop TB Partnership, United States Agency for International Development and Global Laboratory Initiative; 2021 (https://www.stoptb.org/gli-guidance-and-tools/practical-guide-to-implementation-of-truenat-tests).
  17. Manual for selection of molecular WHO-recommended rapid diagnostic tests for detection of tuberculosis and drug-resistant tuberculosis. Geneva: World Health Organization; 2022 (https://www.who.int/publications/i/item/9789240042575).
  18. Sengstake S, Rigouts L. A multicenter evaluation of the Genoscholar PZA-TB II line probe assay to detect pyrazinamide resistance in Mycobacterium tuberculosis isolates: study report. Antwerp.: Institute of Tropical Medicine; 2020.
  19. Practical implementation of lateral flow urine lipoarabinomannan assay (LF-LAM) for detection of active tuberculosis in people living with HIV. Geneva: Global Laboratory Initiative; 2021 (https://www.stoptb.org/gli-guidance-and-tools/practical-implementation-of-lf-lam-detection-of-active-tb-people-living-with).
  20. Use of Xpert MTB/RIF and Xpert MTB/RIF Ultra on GeneXpert 10-colour instruments: WHO policy statement. Geneva: World Health Organization; 2021 (https://www.who.int/publications/i/item/9789240040090).
  21. Beviere M, Reissier S, Penven M, Dejoies L, Guerin F, Cattoir V, Piau C. The Role of Next-Generation Sequencing (NGS) in the Management of Tuberculosis: Practical Review for Implementation in Routine. Pathogens. 2023;12(8).
  22. Commercial serodiagnostic tests for diagnosis of tuberculosis: policy statement. Geneva: World Health Organization; 2011 (https://www.who.int/publications/i/item/9789241502054).
  23. Meeting report of the WHO expert consultation on the definition of extensively drug-resistant tuberculosis. Geneva: World Health Organization; 2020 (https://www.who.int/publications/i/item/meeting-report-of-the-who-expert-consultation-on-the-definition-of-extensively-drug-resistant-tuberculosis).
  24. Technical report on critical concentrations for drug susceptibility testing of medicines used in the treatment of drug-resistant tuberculosis. Geneva: World Health Organization; 2018 (https://www.who.int/publications/i/item/WHO-CDS-TB-2018.5).
  25. HIV Reagent Program [website]. National Institutes of Health HIV Reagent Program; 2023 (https://www.beiresources.org/).
  26. Info note: Access to pure drug substances for DST: bedaquiline and delamanid. Geneva: Stop TB Partnership; 2021 (https://www.stoptb.org/info-note-access-to-pure-drug-substances-dst-bedaquiline-and-delamanid).
  27. Technical report on critical concentrations for drug susceptibility testing of isoniazid and the rifamycins (rifampicin, rifabutin and rifapentine). Geneva: World Health Organization; 2021 (https://www.who.int/publications/i/item/9789240017283).
  28. Target product profile for next-generation drug-susceptibility testing at peripheral centres. Geneva: World Health Organization; 2021 (https://www.who.int/publications/i/item/9789240032361).
  29. World Health Organization, Foundation for Innovative New Diagnostics. The use of next-generation sequencing technologies for the detection of mutations associated with drug resistance in Mycobacterium tuberculosis complex: technical guide (WHO/CDS/TB/2018.19. Geneva: World Health Organization; 2018 (https://www.who.int/publications/i/item/WHO-CDS-TB-2018.19).
  30. The use of next-generation sequencing for the surveillance of drug-resistant tuberculosis: an implementation manual. Geneva: World Health Organization; 2023 (https://www.who.int/publications/i/item/9789240078079).
  31. GLI guide to TB specimen referral systems and integrated networks. Geneva: Global Laboratory Initiative; 2017 (https://www.stoptb.org/file/9737/download).
  32. GLI specimen referral toolkit. Geneva: Global Laboratory Initiative; 2017 (https://www.stoptb.org/gli-guidance-and-tools/gli-specimen-referral-toolkit).
  33. WHO operational handbook on tuberculosis. Module 2: Screening – systematic screening for tuberculosis disease. Geneva: World Health Organization; 2021 (https://www.who.int/publications/i/item/9789240022614).
  34. Considerations for adoption and use of multi-disease testing devices in integrated laboratory networks (WHO/HTM/TB/2017.05. Geneva: World Health Organization; 2017 (https://www.who.int/publications/i/item/WHO-HTM-TB-2017.06).
  35. Tuberculosis laboratory biosafety manual. Geneva: World Health Organization; 2013 (https://www.who.int/publications/i/item/9789241504638).
  36. Practical manual on tuberculosis laboratory strengthening, 2022 update. Geneva: World Health Organization; 2022 (https://www.who.int/publications/i/item/9789240061507).
  37. ISO 15189: 2022 Medical laboratories – requirements for quality and competence. Geneva: International Organization for Standardization; 2022 (https://www.iso.org/standard/76677.html).
  38. Gargis AS, Kalman L, Berry MW, Bick DP, Dimmock DP, Hambuch T et al. Assuring the quality of nextgeneration sequencing in clinical laboratory practice. Nat Biotechnol. 2012;30(11):1033–6 (https://doi.org/10.1038/nbt.2403).
  39. GLI quick guide to TB diagnostics connectivity solution. Geneva: Global Laboratory Initiative; 2016 (https://www.stoptb.org/gli-guidance-and-tools/gli-quick-guide-to-tb-diagnostics-connectivity-solutions).
  40. Tornheim JA, Starks AM, Rodwell TC, Gardy JL, Walker TM, Cirillo DM et al. Building the framework for standardized clinical laboratory reporting of next-generation sequencing data for resistance-associated mutations in Mycobacterium tuberculosis complex. Clin Infect Dis. 2019;69(9):1631–3 (https://doi.org/10.1093/cid/ciz219).
  41. Van Deun A, Aung KJ, Bola V, Lebeke R, Hossain MA, de Rijk WB et al. Rifampin drug resistance tests for tuberculosis: challenging the gold standard. J Clin Microbiol. 2013;51(8):2633–40 (https://doi.org/10.1128/JCM.00553-13).
  42. Berhanu RH, Schnippel K, Kularatne R, Firnhaber C, Jacobson KR, Horsburgh CR, Lippincott CK. Discordant rifampicin susceptibility results are associated with Xpert((R)) MTB/RIF probe B and probe binding delay. Int J Tuberc Lung Dis. 2019;23(3):358–62 (https://doi.org/10.5588/ijtld.16.0837).
  43. Beylis N, Ghebrekristos Y, Nicol M. Management of false-positive rifampicin resistant Xpert MTB/ RIF. Lancet Microbe. 2020;1(6):e238 (https://doi.org/10.1016/S2666-5247(20)30123-3).
  44. Ngabonziza JCS, Decroo T, Migambi P, Habimana YM, Van Deun A, Meehan CJ et al. Prevalence and drivers of false-positive rifampicin-resistant Xpert MTB/RIF results: a prospective observational study in Rwanda. Lancet Microbe. 2020;1(2):e74-e83 (https://doi.org/10.1016/s2666-5247(20)30007-0).
  45. 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) (https://doi.org/10.1128/mbio.00812-17).
  46. Molecular assays intended as initial tests for the diagnosis of pulmonary and extrapulmonary TB and rifampicin resistance in adults and children: rapid communication. Geneva: World Health Organization; 2020 (https://apps.who.int/iris/bitstream/handle/10665/330395/9789240000339-eng.pdf).
  47. Dorman SE, Schumacher SG, Alland D, Nabeta P, Armstrong DT, King B et al. Xpert MTB/RIF Ultra for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre diagnostic accuracy study. Lancet Infect Dis. 2018;18(1):76–84 (https://doi.org/10.1016/S1473-3099(17)30691-6)
  48. Steingart KR, Schiller I, Horne DJ, Pai M, Boehme CC, Dendukuri N. Xpert(R) MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in adults. Cochrane Database Syst Rev. 2014;2014(1):CD009593 (https://doi.org/10.1002/14651858.CD009593.pub3).
  49. Cao Y, Parmar H, Gaur RL, Lieu D, Raghunath S, Via N et al. Xpert MTB/XDR: A 10-color reflex assay suitable for point of care settings to detect isoniazid-, fluoroquinolone-, and second-line-injectable-drug resistance directly from Mycobacterium tuberculosis-positive sputum. J Clin Microbiol. 2021;59(3) (https://doi.org/10.1128/JCM.02314-20).
  50. Sanchez-Padilla E, Merker M, Beckert P, Jochims F, Dlamini T, Kahn P et al. Detection of drug-resistant tuberculosis by Xpert MTB/RIF in Swaziland. N Engl J Med. 2015;372(12):1181–2 (https://doi.org/10.1056/NEJMc1413930).
  51. Ismail NA, McCarthy K, Conradie F, Stevens W, Ndjeka N. Multidrug-resistant tuberculosis outbreak in South Africa. Lancet Infect Dis. 2019;19(2):134–5 (https://doi.org/10.1016/S1473-3099(18)30715-1).
  52. Lateral flow urine lipoarabinomannan assay (LF-LAM) for the diagnosis of active tuberculosis in people living with HIV, 2019 Update. Geneva: Global Laboratory Initiative; 2019 (https://www.who.int/publications/i/item/9789241550604).
  53. Implementing tuberculosis diagnostics: a policy framework (WHO/HTM/TB/2015.11 Geneva: World Health Organization; 2015 ((https://www.who.int/publications/i/item/9789241508612).
  54. Ismail NA, Aono A, Borroni E, Cirillo DM, Desmaretz C, Hasan R et al. A multimethod, multicountry evaluation of breakpoints for bedaquiline resistance determination. Antimicrob Agents Chemother. 2020;64(9) (https://doi.org/10.1128/AAC.00479-20).
  55. WHO consolidated guidelines on tuberculosis. Module 4: Treatment – drug-susceptible tuberculosis treatment. Geneva: World Health Organization; 2022 (https://www.who.int/publications/i/item/9789240048126).
  56. Dean AS, Zignol M, Cabibbe AM, Falzon D, Glaziou P, Cirillo DM et al. Prevalence and genetic profiles of isoniazid resistance in tuberculosis patients: a multicountry analysis of cross-sectional data. PLoS Med. 2020;17(1):e1003008 (https://doi.org/10.1371/journal.pmed.1003008).
  57. WHO treatment guidelines for isoniazid-resistant tuberculosis. Geneva: World Health Organization; 2018 (https://apps.who.int/iris/bitstream/handle/10665/260494/9789241550079-eng.pdf).

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