Article

Innovation in HCV serology assays – building the change in hepatitis C elimination

Expansion of Roche’s hepatitis diagnostic portfolio

8 out 10 people with hepatitis C do not know they are at risk.1

Hepatitis C is an inflammatory liver disease caused by infection with the hepatitis C virus (HCV). HCV can cause both acute and chronic hepatitis resulting in long-term consequences for patients including fibrosis, cirrhosis, liver cancer and death.2

Tremendous diagnostic and therapeutic advances have been made since the discovery of HCV in 1989.3 Since 2016, the availability of highly efficacious therapies, based on direct-acting antivirals, mean that more than 95% of people can be considered cured after treatment.4 And yet, the hepatitis C disease burden is still significant – across the world, 58 million people are living with chronic HCV infection.1 In 2019 alone, there were 1.5 million new infections and 290,000 people died from HCV infection-related causes.1

The global WHO hepatitis strategy: aiming for a future without viral hepatitis

 

Whilst viral hepatitis can affect anyone, injecting drug use is the major contributor to the hepatitis C epidemic globally, and the people and communities most underserved by health systems are disproportionately affected.1

In 2016, the World Health Organization (WHO) approved a global health sector strategy to achieve elimination of viral hepatitis, including hepatitis C, as a major public health threat by 2030.6 The WHO targets apply to all populations affected and at risk of viral hepatitis.6

Icon HCV Duo

Reduce infections by 90%

Icon HCV Duo

Reduce deaths by 65%

Roche is committed to supporting the fight to eliminate hepatitis

 

Viral hepatitis can be stopped in its tracks. Early detection of HCV infection is crucial to allow treatment, prevent or delay disease progression, and effectively disrupt virus transmission.2, 7

As a community, we need to employ all available tools and resources at our disposal – effective diagnosis is critical to the success of the HCV elimination strategy.6

Early detection

Early detection

  • Acute hepatitis C is not easily identified
  • Antibodies often absent in the early phase
Timely treatment

Timely optimum treatment

Disrupt spread virus

Disrupt spread of the virus

Simplifying the pathway to hepatitis C diagnosis through innovation – the Elecsys® HCV Duo immunoassay

 

Diagnosis of acute hepatic injury is made by measurement of markers of liver function or health, such as the liver enzymes alanine aminotransferase [ALT] and aspartate transaminase [AST].8 For access to effective treatment, it is important to determine whether the causative agent of hepatitis is viral in origin.2 The Elecsys® HCV Duo assay expands Roche’s comprehensive viral hepatitis test portfolio, which includes molecular and serology solutions, to help diagnose and manage patients with acute or chronic viral hepatitis infection.

Markers used to detect HCV infection appear in the body at different times during the course of infection.9

 

Direct viral markers, such as HCV core antigen (HCV cAg) and HCV RNA, appear earlier than anti-HCV antibodies which occur approximately 6 to 12 weeks after infection.9

The innovative Elecsys® HCV Duo assay provides real diagnostic benefits for detecting HCV infection by significantly shortening the diagnostic window period by up to 3 weeks compared with traditional testing regimens, based on first-line anti-HCV antibody testing only.10

Diagnostic window period

The standard HCV screening and diagnosis algorithm is based on the detection of anti-HCV antibodies as the first step, followed by HCV RNA or HCV cAg.2, 11, 12

 

Addition of simultaneous HCV cAg measurement provides opportunities for the Elecsys® HCV Duo assay to simplify the HCV diagnostic pathway — as a surrogate marker for HCV RNA, a positive HCV cAg result indicates active HCV infection (viremia) — and could eliminate the need for additional subsequent confirmatory testing in a substantial proportion of tested samples.*
 

*Due to the lower analytical sensitivity of HCV cAg  compared with HCV RNA testing, anti-HCV antibody-positive/HCV cAg-negative samples should have a confirmatory HCV RNA test to exclude a false-negative HCV cAg result.2, 11, 12

HCV testing algorithm
Elecsys HBsAg II

Usage of the Elecsys® HCV Duo assay

 

  • In conjunction with other laboratory results and clinical information, may be used to aid in the diagnosis of, and the screening for, HCV infection
  • Used as a screening test to prevent transmission of HCV to recipients of blood, blood components, cells, tissue, and organs, especially in territories where national guidelines recommend anti-HCV and HCV antigen testing
  • Used as an aid in the selection of the confirmatory testing algorithm for reactive samples

 

Patients benefit from early diagnosis

 

HCV infection is often not identified in its early stages as the majority of newly infected patients will be asymptomatic, and can remain so until serious liver damage has occurred.13 There can be a lack of specific clinical symptoms in the early stage in those who do present with symptoms,13 yet only people who know they are infected can be treated. The earlier HCV infection is diagnosed, the earlier optimum treatment can be offered.

Current guidelines recommend testing in the general population, under specific conditions of prevalence, and/or targeted testing in particular at-risk groups.11, 12

 

If detected, hepatitis C is treatable & curable – when patients are linked early to treatment, testing with the Elecsys® HCV Duo assay can reduce the risk of progression to cirrhosis, end-stage liver disease and hepatocellular carcinoma2, 7

High sensitivity

Single specimen
testing

Increases convenience and reduces the number of clinic visits that a patient needs to make

High sensitivity

High sensitivity for early detection of infection14

High sensitivity for all stages of HCV infection

Earlier detection of HCV infection vs antibody-only tests# allows timely access to treatment and helps to stop the spread of HCV14

High sensitivity

Detection of all clinically relevant HCV genotypes14

Testing is relevant for all geographical regions

#The Elecsys® HCV Duo assay detected HCV infection on average 1.8 days after measurement of HCV RNA. This is 22–23 days earlier than the antibody-only tests.10

Example

Elecsys® HCV Duo

Immunoassay for the qualitative dual detection of hepatitis C virus (HCV) core antigen and antibodies to HCV

References

1. World Health Organization. Global progress report on HIV, viral hepatitis and sexually transmitted infections, 2021. https://www.who.int/publications/i/item/9789240027077. Accessed May 30, 2022.

2. Manns MP, Buti M, Gane E, et al. Hepatitis C virus infection. Nat Rev Dis Primers. 2017;3:17006. doi: 10.1038/nrdp.2017.6.

3. Pol S and Lagaye S. The remarkable history of the hepatitis C virus. Genes Immun. 2019;20(5):436–446. doi: 10.1038/s41435-019-0066-z.

4. Spearman CW, Dusheiko GM, Hellard M, et al. Hepatitis C. Lancet. 2019;394(10207):1451–1466. doi: 10.1016/S0140-6736(19)32320-7.

5. World Health Organization. Accelerating access to hepatitis C diagnostics and treatment, 2020. https://www.who.int/publications/i/item/9789240019003. Accessed July 9, 2022.

6. World Health Organization. Global health sector strategy on viral hepatitis 2016–2021. Towards ending viral hepatitis. https://apps.who.int/iris/handle/10665/246177. Accessed May 30, 2022.

7. Easterbrook PJ, Roberts T, Sands A, et al. Diagnosis of viral hepatitis. Curr Opin HIV AIDS. 2017;12(3):302–314. doi: 10.1097/COH.0000000000000370.

8. Dufour DR, Lott JA, Nolte FS, et al. Diagnosis and monitoring of hepatic injury. II. Recommendations for use of laboratory tests in screening, diagnosis, and monitoring. Clin Chem. 2000;46(12):2050–2068. doi: 10.1093/clinchem/46.12.2050.

9. World Health Organization. Guidelines on hepatitis B and C testing. https://www.who.int/publications/i/item/9789241549981. Accessed June 1, 2022.

10. Majchrzak M. et al. (2022) Multicentre performance evaluation of the Elecsys HCV Duo immunoassay. Poster presented at European Association for the Study of the Liver, The International Liver Congress; 22–26 June 2022; London, UK.

11. American Association for the Study of Liver Diseases, Infectious Diseases Society of America. HCV testing and linkage to care. 2021. https://www.hcvguidelines.org/evaluate/testing-and-linkage. Accessed May 30, 2022.

12. European Association for the Study of the Liver. EASL recommendations on treatment of hepatitis C: Final update of the series. J Hepatol. 2020;73(5):1170–1218. doi: 10.1016/j.jhep.2020.08.018.

13. World Health Organization. Hepatitis C. https://www.who.int/en/news-room/fact-sheets/detail/hepatitis-c. Accessed May 30, 2022.

14. Elecsys® HCV Duo (Mat. No. 08110697190) method sheet, V1 2021-06.