REFERENCES

  1. Polaris Observatory HCV Collaborators. Global change in hepatitis C virus prevalence and cascade of care between 2015 and 2020: a modelling study. Lancet Gastroenterol Hepatol 2022;7:396-415. Available at: https://pubmed.ncbi.nlm.nih.gov/35180382/ (last accessed 22 July 2024).

  2. King, J., Kwon J., McManus, H., Gray, R., & McGregor, S., 2024, HIV, viral hepatitis and sexually transmissible infections in Australia: Annual surveillance report 2024, The Kirby Institute, UNSW Sydney, Sydney, Australia.

  3. World Health Organization (WHO). Global health sector strategy on viral hepatitis 2016–2021. Towards ending viral hepatitis. Geneva: World Health Organization; 2016. Available at: http://www.who.int/hepatitis/strategy2016-2021/ghss-hep/en (last accessed 21 May 2020).

  4. Sixth National Hepatitis C Strategy 2025-2030. Available at: https://www.health.gov.au/resources/collections/national-strategies-for-bloodborne-viruses-and-sexually-transmissible-infections (last accessed 25 November 2024).

  5. World Health Organization (WHO). Guidelines on hepatitis B and C testing. February 2017. Geneva: World Health Organization; 2017. Licence: CC BY-NC-SA 3.0 IGO.

  6. Cunningham EB, Wheeler A, Hajarizadeh B, et al. Interventions to enhance testing, linkage to care, and treatment initiation for hepatitis C virus infection: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol 2022;7:426–45.

  7. World health Organization (WHO). Hepatitis C Fact Sheet. 9 April 2024. Available at: https://www.who.int/news-room/fact-sheets/detail/hepatitis-c (last accessed 24 November 2024).

  8. Ghany MG, Strader DB, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology 2009;49:1335-74.

  9. European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of hepatitis C virus infection. J Hepatol. 2014 Feb;60(2):392-420.

  10. Hajarizadeh B, Carson JM, Dore GJ. Monitoring hepatitis C treatment uptake in Australia (Issue 13). The Kirby Institute, UNSW, Sydney NSW, Australia, July 2023. Available at: https://www.kirby.unsw.edu.au/research/reports/monitoring-hepatitis-c-treatment-uptake-australia-issue-13-july-2023 (last accessed 22 July 2024).

  11. Australian Register of Therapeutic Goods (ARTG). Cepheid Holdings Pty Ltd - Xpert HCV VL - Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT). ARTG ID 342734. Available at: https://www.tga.gov.au/resources/artg/342734 (last accessed 22 July 2024).

  12. Australian Register of Therapeutic Goods (ARTG). TD Analytical and Medical - INSTI Hepatitis C (HCV) Antibody test - Hepatitis C virus total antibody IVD, kit, immunochromatographic test (ICT), rapid. ARTG ID 448926. Available at: https://www.tga.gov.au/resources/artg/448926 (last accessed 22 July 2024).

  13. Australian Government. Attorney-General’s Department. Australia’s anti-discrimination law [internet]. Available at: https://www.ag.gov.au/RightsAndProtections/HumanRights/Pages/Australias-Anti-Discrimination-Law.aspx (last accessed 22 July 2024).

  14. Australian Government. Department of Health and Aged Care. Pathology [internet]. Available at: https://www.health.gov.au/topics/pathology (last accessed 22 July 2024).

  15. Australian Government. Department of Health and Aged Care. Medicare Benefits Schedule Online [internet]. Available at: http://www.mbsonline.gov.au/internet/mbsonline/publishing.nsf/Content/Home (last accessed 22 July 2024).

  16. Australian Government. Department of Health and Aged Care. Therapeutic Goods (Standard for Human Cell and Tissue Products— Donor Screening Requirements) (TGO 108) Order 2021. Available at: https://www.tga.gov.au/resources/legislation/therapeutic-goods-standard-human-cell-and-tissue-products-donor-screening-requirements-tgo-108-order-2021 (last accessed 26 November 2024).

  17. Australian Government. Department of Home Affairs. Meeting our requirements: health [internet]. Available at: https://immi.homeaffairs.gov.au/help-support/meeting-our-requirements/health (last accessed 22 July 2024).

  18. Defence Force Recruiting. Medical Assessment Process. Revised 20/01/2023. Available at: https://www.adfcareers.gov.au/-/media/DFR/Files/DFT_Document_MedicalProcess.pdf?download=tru (last accessed 22 July 2024).

  19. Mulcahy S, Seear K, Fraser S, et al. Insurance discrimination and hepatitis C: recent developments and the need for reforms. Insurance Law J 2022;32:93-105.

  20. NSW Health. Communities and Justice. Mandatory Disease Testing Scheme [internet]. Available at: https://dcj.nsw.gov.au/legal-and-justice/mandatory-disease-testing-scheme.html (last accessed 26 November 2024).

  21. Australian Government. National Health and Medical Research Council. National Statement on Ethical Conduct in Human Research 2023. Canberra: National Health and Medical Research Council; 2023. Available at: https://www.nhmrc.gov.au/research-policy/ethics/national-statement-ethical-conduct-human-research (last accessed 26 November 2024).

  22. Australian Government. Department of Health and Aged Care. Therapeutic Goods Administration. Medical devices [internet]. Available at: https://www.tga.gov.au/products/medical-devices (last accessed 26 November 2024).

  23. Australian Government. Department of Health and Aged Care. National strategies for bloodborne viruses and sexually transmissible infections. Available at: https://www.health.gov.au/resources/collections/national-strategies-for-bloodborne-viruses-and-sexually-transmissible-infections (last accessed 30 October 2024).

  24. Australian Government. Department of Health and Aged Care. Australian Register of Therapeutic Goods (ARTG) [internet]. Available at: https://www.tga.gov.au/australian-register-therapeutic-goods (last accessed 22 July 2024).

  25. Kleinman SH, Lelie N, Busch MP. Infectivity of human immunodeficiency virus-1, hepatitis C virus, and hepatitis B virus and risk of transmission by transfusion. Transfusion 2009;49:2454-89.

  26. Marwaha N, Sachdev S. Current testing strategies for hepatitis C virus infection in blood donors and the way forward. World J Gastroenterol 2014;20:2948-54.

  27. Australian Commission on Safety and Quality in Health Care. Requirements for laboratory testing for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) (Fourth Edition). Available at: https://www.safetyandquality.gov.au/publications-and-resources/resource-library/requirements-laboratory-testing-human-immunodeficiency-virus-hiv-and-hepatitis-c-virus-hcv-fourth-edition (last accessed 22 July 2024).

  28. Australian Red Cross Lifeblood. Donation testing [internet]. Available at: https://www.lifeblood.com.au/health-professionals/testing/donation (last accessed 26 November 2024).

  29. Grebely J, Prins M, Hellard M, et al. for the International Collaboration of Incident HIV and Hepatitis C in Injecting Cohorts (InC3). Hepatitis 32 | National Hepatitis C Testing Policy 2025 testingportal.ashm.org.au | 33 C virus clearance, reinfection, and persistence, with insights from studies of injecting drug users: towards a vaccine. Lancet Infect Dis 2012;12:408-14.

  30. National Pathology Accreditation Advisory Council. Requirements for Medical Pathology Services (Third Edition 2018). Available at: https://www.safetyandquality.gov.au/publications-and-resources/resource-library/requirements-medical-pathology-services-third-edition-2018 (last accessed 22 July 2024).

  31. National Association of Testing Authorities. Human Pathology (ISO 15189 ) [internet] Available at: https://nata.com.au/accreditation/medical-laboratory-accreditation-iso-15189/ (last accessed 22 July 2024).

  32. Tao Y, Tang W, Fajardo E, et al. Reflex hepatitis C virus viral load testing following an initial positive hepatitis C virus antibody test: A global systematic review and meta-analysis. Clin Infect Dis 2023;77:1137-56.

  33. Trickey A, Fajardo E, Alemu D, Artenie AA, Easterbrook P. Impact of hepatitis C virus point-of-care RNA viral load testing compared with laboratory-based testing on uptake of RNA testing and treatment, and turnaround times: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol 2023;8:253-70.

  34. Sheehan Y, Cunningham EB, Cochrane A, et al. A 'one-stop-shop' point-of-care hepatitis C RNA testing intervention to enhance treatment uptake in a reception prison: The PIVOT study. J Hepatol 2023;79:635-44.

  35. Shih STF, Cheng Q, Carson J, et al. Optimizing point-of-care testing strategies for diagnosis and treatment of hepatitis C virus infection in Australia: a model-based cost-effectiveness analysis. Lancet Reg Health West Pac 2023;36:100750.

  36. Australian Government. Department of Health. National Pathology Accreditation Advisory Council. Requirements for point of care testing (Second Edition 2021). Available at: https://www.safetyandquality.gov.au/publications-and-resources/resource-library/requirements-point-care-testing-second-edition-2021 (last accessed 26 November 2024).

  37. Grebely J, Lamoury FMJ, Hajarizadeh B, et al; LiveRLife Study Group. Evaluation of the Xpert HCV viral load point-of-care assay from venepuncture-collected and finger-stick capillary whole-blood samples: a cohort study. Lancet Gastroenterol Hepatol 2017;2:514-20.

  38. Lamoury FMJ, Bajis S, Hajarizadeh B, et al; LiveRLife Study Group. Evaluation of the Xpert HCV viral load finger-stick point-of-care assay. J Infect Dis 2018;217:1889-96.

  39. Australian Government. Department of Health and Aged Care. TD Analytical and Medical - INSTI Hepatitis C (HCV) Antibody test - Hepatitis C virus total antibody IVD, kit, immunochromatographic test (ICT), rapid (448926). ARTG ID 448926. Available at: https://www.tga.gov.au/resources/artg/448926 (last accessed 26 November 2024).

  40. Catlett B, Hajarizadeh B, Cunningham E, et al. Diagnostic accuracy of assays using point-of-care testing or dried blood spot samples for the determination of hepatitis C virus RNA: a systematic review.J Infect Dis 2022;226:1005-21.

  41. World Health Organization, Recommendations and guidance on hepatitis C virus self-testing. 15 July 2021. [internet]. Available at: https://www.who.int/publications/i/item/9789240031128 (last accessed 13 March 2025).

  42. Carrington N, Conway A, Grebely J, et al. Testing, diagnosis, and treatment following the implementation of a program to provide dried blood spot testing for HIV and hepatitis C infections: the NSW DBS Pilot. BMC Infect Dis 2024;24:137.

  43. Conway A, Stevens A, Murray C, et al. Hepatitis C treatment uptake following dried blood spot testing for hepatitis C RNA in New South Wales, Australia: the NSW DBS Pilot Study. Open Forum Infect Dis 2023;10:ofad517.

  44. Gane E, de Ledinghen V, Dylla DE, et al. Positive predictive value of sustained virologic response 4 weeks posttreatment for achieving sustained virologic response 12 weeks posttreatment completion in patients receiving glecaprevir/pibrentasvir in Phase 2 and 3 clinical trials. J Viral Hepat 2021;28:1635-42.

  45. Sulkowski M, Feld JJ, Reau NS, et al. Concordance of SVR 4-12-24 timepoints in an era of reduced sustained virologic response (SVR) determination. J Hepatol 2021; 75 Suppl 2: S294-S803.

  46. Increase in routine hepatitis C RNA testing required to achieve elimination. Government of South Australia. Available at: https://www.sahealth.sa.gov.au/wps/wcm/connect/public+content/sa+health+internet/public+health/

  47. Australian Government Department of Health and Aged Care. Australian national guidelines for the management of healthcare workers living with blood borne viruses and healthcare workers who perform exposure prone procedures at risk of exposure to blood borne viruses. Available at: https://www.health.gov.au/resources/collections/cdna-national-guidelines-for-healthcare-workers-on-managing-bloodborne-viruses (last accessed 13 December 2024)

  48. Hepatitis C Virus Infection Consensus Statement Working Group. Australian recommendations for the management of hepatitis C virus infection: a consensus statement [2022]. Melbourne: Gastroenterological Society of Australia, 2022. Available at: https://www.hepcguidelines.org.au/wp-content/uploads/2022/11/hepatitis-C-virus-infection-a-consensus-statement-2022.pdf (last accessed 26 November 2024).

  49. Razali K, Thein HH, Bell J, et al. Modelling the hepatitis C virus epidemic in Australia. Drug Alcohol Depend 2007;91:228-35.

  50. Grebely J, Robaeys G, Bruggmann P, et al. for the International Network for Hepatitis in Substance Users. Recommendations for the management of hepatitis C virus infection among people who inject drugs. Int J Drug Policy 2015;26:1028-38.

  51. US Centers for Disease Control and Prevention (CDC). Hepatitis C. Testing for hepatitis C. December 19, 2023 [internet]. Available at : https://www.cdc.gov/hepatitis-c/testing/index.html (last accessed 26 November 2024).

  52. Hajarizadeh B, Carson J, Byrne M et al. Incidence of hepatitis C virus infection in the prison setting: The SToP-C study. Journal of Viral Hepatitis. Volume 31, Issue 1 p. 21-34.

  53. Winter RJ, Sheehan Y, Papaluca TJ, et al. on behalf of the National Prisons Hepatitis Network. Consensus recommendations on the management of hepatitis C in Australia's prisons. Med J Aust 2023;218:231-7.

  54. Australian Government. Senate Committee Report. Hepatitis C and the blood supply in Australia. Canberra: Commonwealth of Australia; 2004. Available at: https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/Completed_inquiries/2002-04/hepc/report/index (last accessed 22 July 2024).

  55. World Health Organization (WHO). Blood safety and availability. 2 June 2023 [internet]. Available at: https://www.who.int/news-room/fact-sheets/detail/blood-safety-and-availability (last accessed 22 July 2024).

  56. Government of Western Australia. Department of Health. Code of practice for skin penetration procedures 1998. Minor update 24 January 2017. Available at: https://ww2.health.wa.gov.au/~/media/Files/Corporate/general%20documents/communicable%20diseases/PDF/Code_of_Practice_for_Skin_Penetration.ashx (last accessed 24 July 2022).

  57. Spradling P. Travelers’ Health. Hepatitis C. CDC Yellow Book 2024. Travel-associated infections and diseases. New York: Oxford University Press; 2024. Available at: https://wwwnc.cdc.gov/travel/yellowbook/2024/infections-diseases/hepatitis-c (last accessed 22 July 2024).

  58. Australian Government. Australian Bureau of Statistics. Estimates of Aboriginal and Torres Strait Islander Australians. 30 June 2021. Available at: https://www.abs.gov.au/statistics/people/aboriginal-and-torres-strait-islander-peoples/estimates-aboriginal-and-torres-strait-islander-australians/latest-release (last accessed 22 July 2024). testingportal.ashm.org.au | 33 34 | National Hepatitis C Testing Policy 202534 | National Hepatitis C Testing Policy 2025

  59. Naruka E, Miller A, Thomas JR, et al. Bloodborne viral and sexually transmissible infections in Aboriginal and Torres Strait Islander peoples: Annual surveillance report 2023. Kirby Institute, UNSW Sydney; 2023. Available at http://handle.unsw.edu.au/1959.4/unsworks_84780 (last accessed 22 July 2024).

  60. Australian Government. Australian Law Reform Commission. Pathways to Justice–Inquiry into the Incarceration Rate of Aboriginal and Torres Strait Islander Peoples (ALRC Report 133). Executive Summary: Disproportionate incarceration rate. Tabled 28 March 2018. Available at: https://www.alrc.gov.au/publication/pathways-to-justice-nquiry-intothe-incarceration-rate-of-aboriginal-and-torres-straitislander-peoples-alrc-report-133/executive-summary-15/disproportionate-incarceration-rate/ (last accessed 22 July 2024).

  61. World Health Organization (WHO). Updated recommendations on treatment of adolescents and children with chronic HCV infection, and HCV simplified service delivery and diagnostics. Geneva: World Health Organization; 2022. Available at: https://www.who.int/publications/i/item/9789240052734 (last accessed 26 November 2024).

  62. Timofte D, Dragos D, Balcangiu-Stroescu AE, et al. Infection with hepatitis C virus in hemodialysis patients: An overview of the diagnosis and prevention rules within a hemodialysis center (Review). Exp Ther Med 2020;20:109–16.

  63. Moorman AC, de Perio MA, Goldschmidt R, et al. Testing and Clinical Management of Health Care Personnel Potentially Exposed to Hepatitis C Virus — CDC Guidance, United States, 2020. MMWR Recomm Rep 2020;69(No. RR-6):1–8.

  64. Australian Commission on Safety and Quality in Health Care. Informed Consent in Health Care. Fact Sheet for Clinicians. Available at: https://www.safetyandquality.gov.au/sites/default/files/2020-09/sq20-030_-_fact_sheet_-_informed_consent_-_nsqhs-8.9a.pdf (last accessed 22 July 2024).

  65. Lenton E, Johnson J, Brown G. Upscaling HIV and hepatitis C testing in primary healthcare settings: stigma-sensitive practice. Aust J Prim Health 2021;27:255-8.

  66. Australian Government. Department of Home Affairs. Translating and Interpreting Service (TIS National). Available at: https://www.tisnational.gov.au/ (last accessed 22 July 2025).

  67. Multi Cultural Hivhepc Services. Available at: https://www.multiculturalhivhepc.net.au/ (last accessed 22 July 2025).

  68. Hepatitis Australia. Fact Sheet. Your rights and responsibilities: Living with hepatitis B or hepatitis C [internet]. Available at: https://www.hepatitisaustralia.com/Handlers/Download.ashx?IDMF=dcdf13fa-922d-42d8-8f64-3899f6116b16 (last accessed 22 July 2025).

  69. Hepatitis Australia. Testing for hepatitis C [internet]. Updated November 2022. Available at: https://www.hepatitisaustralia.com/testing-for-hepatitis-c (last accessed 22 July 2024).

  70. Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM). Decision Making in Hepatitis C. Updated November 2024. Available at: https://ashm.org.au/resources/decision-making-in-hepatitis-c/ (last accessed 26 November 2024).

  71. Lafferty L, Rance J, Treloar C. Who goes first? Understanding hepatitis C risk among injecting networks in the prison setting. Drug Alcohol Depend 2018;183:96-101.

  72. Lafferty L, Rance J, Dore GJ, Lloyd AR, Treloar C. The role of social capital in facilitating hepatitis C treatment scale-up within a treatment-as-prevention trial in the male prison setting. Addiction 2021;116:1162-71.

  73. Chong S, Brown G, Crawford S, et al. Hepatitis C treatment: peer insights on barriers and motivators to direct acting antiviral (DAA) treatment uptake (Broadsheet No. 2). Melbourne: Australian Research Centre in Sex, Health and Society, La Trobe University; 2018. Available at: https://www.latrobe.edu.au/__data/assets/pdf_file/0017/1011905/ARCSHS-Peer-Insights-Hep-CTreatment-Uptake-Broadsheet-2.pdf (last accessed 22 July 2024).

  74. Bryant J, Rance J, Hull P, Mao L, Treloar C. Making sense of ‘side effects’: counterpublic health in the era of directacting antivirals. Intl J Drug Policy 2019;72:77-83.

  75. Royal Australian College of General Practitioners. Standards for general practices. 5th edition. East Melbourne; The Royal Australian College of General Practitioners: 2020. Available at: https://www.racgp.org.au/running-a-practice/practice-standards/standards-5th-edition/standards-for-general-practices-5th-ed (last accessed 22 July 2024).

  76. Australian Government. Department of Health and Aged Care. National Notifiable Diseases Surveillance System (NNDSS). Available at: https://www.health.gov.au/our-work/nndss (last accessed 22 July 2024).

  77. Prince DS, Pipicella JL, Fraser M, et al. SEARCH: Screening emergency admissions at risk of chronic hepatitis C (SEARCH) to diagnose or ‘re-diagnose’ infections is effective in Australia. J Viral Hep 2021;28:121-8.

  78. Hutton J, Doyle J, Zordan R, et al. Point-of-care Hepatitis C virus testing and linkage to treatment in an Australian inner-city emergency department. Int J Drug Policy 2019;72:84-90.

  79. Kirby Institute and University of New South Wales. Australian Needle and Syringe Program (NSP) Survey National Data Report 2017-2021. Available at: https://www.kirby.unsw.edu.au/research/reports/australian-nsp-survey-national-data-report-2017-2021 (last accessed 22 July 2024).

  80. Iversen J, Dore GJ, Starr M, et al. Estimating the consensus hepatitis C cascade of care among people who inject drugs in Australia: pre and post availability of direct acting antiviral therapy. Int J Drug Policy 2020;83:102837.

  81. Iversen J, Wand H, McManus H, Dore GJ, Maher L. Incidence of primary hepatitis C infection among people who inject drugs in Australia: Pre- and post- unrestricted availability of direct acting antiviral therapies. Addiction 2023;118:901-11.

  82. Australian Government. Department of Health and Aged Care. Therapeutic Goods Administration. Unapproved therapeutic goods [internet]. Available at: https://www.tga.gov.au/products/unapproved-therapeutic-goods (last accessed 23 October 2024).

  83. Australasian Legal Information Institute. Therapeutic Goods (Medical Devices) Regulations 2002- Schedule 4 Exempt devices. Available at: https://www.austlii.edu.au/cgi-bin/viewdoc/au/legis/cth/consol_reg/tgdr2002400/sch4.html (last accessed 22 July 2024).

  84. Australian Government. Department of Health and Aged Care. Communicable Diseases Network Australia (CDNA) National Guidelines for the management of healthcare workers living with blood borne viruses and healthcare workers who perform exposure prone procedures at risk of exposure to blood borne viruses. Updated September 2019. Available at: https://www.health.gov.au/resources/publications/cdna-national-guidelines-healthcare-workers-living-with-blood-borne-viruses-perform-exposure-prone-procedures-at-risk-of-exposure-to-blood-borne-viruses?language=en (last accessed 26 November 2024).

  85. Royal Australian and New Zealand College of Obstetricians and Gynecologists (RANZCOG). Clinical Statement. Management of hepatitis C in pregnancy. Revised March 2020. Available at: https://ranzcog.edu.au/RANZCOG_SITE/media/RANZCOG-MEDIA/Women%27s%20Health/Statement%20and%20guidelines/Clinical-Obstetrics/Management-of-Hepatitis-C-in-Pregnancy-(C-Obs-51).pdf?ext=.pdf (last accessed 22 July 2024).

  86. Benova L MY, Calvert C, Abu-Raddad LJ. Vertical transmission of hepatitis C virus: systematic review and meta-analysis. Clin Infect Dis 2014 Sep;59:765-73.

  87. Australian Commentary Paediatric Guidelines Committee Members. HCV in Children: Australian Commentary on AASLD-IDSA Guidance. 2024. Available at: https://ashm.org.au/wp-content/uploads/2024/05/HCV_in_Children_AU_Commentary_Final_Mar2024.pdf (last accessed 26 November 2024).

  88. National Association of Testing Authorities Australia (NATA). What is accreditation [internet]? Available at: https://www.nata.com.au/accreditation-information/accreditation-criteria-and-guidance (last accessed 22 July 2024).

  89. National Reference Laboratory (NRL). External Quality Assessment Schemes (EQAS) [internet]. Available at: https://www.nrlquality.org.au/products-services/eqas/#:~:text=NRL%20External%20Quality%20Assessment%20Schemes,interpretation%20of%20patient%20test%20result (last accessed 26 November 2024).

  90. Australian Commission on Safety and Quality in Health Care. The National General Practice Accreditation (NGPA) Scheme. Available at: https://www.safetyandquality.gov.au/our-work/accreditation/national-general-practice-accreditation-scheme (last accessed 22 July 2024).

  91. Royal Australian College of General Practitioners (RACGP). Standards for point-of-care testing 5th edition. Available at: https://www.racgp.org.au/getattachment/ee9089f7-fbae-4cd3-bafc-c3d9e7ce2aa8/Standards-for-point-of-care-testing.aspx (last accessed 26 November 2024).

  92. Australian Government. Federal Register of Legislation. Therapeutic Goods Act 1989. No. 21 1990 [internet]. C2024C00263 (C85) 01 July 2024. Available at: https://www.legislation.gov.au/C2004A03952/latest/text (last accessed 22 July 2024). testingportal.ashm.org.au | 35