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How PCR-based diagnostics is changing the fight against hepatitis

Understanding the role of PCR-based testing in improving the diganosis and treatment of viral hepatitis

Viral hepatitis comes in many forms. The most prominent strains, hepatitis B and C (HBV and HCV, respectively), affect approximately 354 million people worldwide1. These infections can cause liver inflammation and damage that lead to serious health complications – including cancer and cirrhosis of the liver, and even death1 – yet testing and treatment remain beyond the reach of many individuals.

According to a World Health Organization (WHO) study, vaccination, diagnostic tests, medicines and education campaigns could prevent an estimated 4.5 million premature deaths in low- and middle-income countries by 2030.1 The 2016 WHO Global Health Sector Strategy (GHSS) on viral hepatitis established a roadmap for the elimination of viral hepatitis as a public health problem, with the goal of reducing new hepatitis infections by 90 percent, and deaths by 65 percent, by 2030.1–4

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Developing an assay for hepatitis?

WHO 2030 hepatitis elimination targets2

90%

reduction in new cases of chronic hepatitis B and C by 2030

65%

reduction in hepatitis-related deaths

80%

of eligible people with chronic hepatitis B and C infections treated by 2030


How PCR is changing the game in the fight against hepatitis

Prior to the development of nucleic acid testing (NAT), virus detection was routinely performed by cell culture, electron microscopy, complement fixation, agglutination assays and immune‐based tests, but these approaches are time consuming and have low sensitivity and precision.14 Today, these methods and have been widely replaced by NAT-based assays such as PCR. 


Laboratories have been exploring the use of PCR-based hepatitis diagnostics since as far back as the early 1990s,6 taking advantage of this sophisticated method for detecting viral nucleic acids in blood samples.  This technique amplifies small fragments of viral nucleic acids to allow the sensitive and specific detection of the presence of viral genomes, even at low concentrations. It is employed both qualitatively – to determine whether or not the virus is present – and quantitively, to measure the amount of HBV-DNA or HCV-RNA present in the blood. This provides complementary information to other investigations, such as antibody and liver function tests.7-9 PCR offers an invaluable tool to diagnose active infections and to monitor patient response to antiviral therapies,5,10,11 as quantitative tests can detect changes in viral load over time. It can also be used to monitor the continued effectiveness of treatments, as well as to screen for reinfection.12 Finally, these assays can identify the emergence of drug-resistant viral variants, guiding ongoing treatment decisions and helping to prevent treatment failure.13

Diagnostic test manufacturers’ role in the fight against hepatitis

PCR-based diagnostics is helping to improve patient outcomes and prevent the spread of disease by providing high quality and reliable results that give clinicians and patients the confidence they need to effectively fight the infection. The patient population affected by hepatitis is vast – encompassing people from all walks of life1,14 – but the burden of the disease is highest in low- and middle-income countries, where access to testing and treatment is often limited. 

Diagnostic test manufacturers must continue to aim for making their assays affordable and accessible. “Easier said than done,” you might be thinking. Finding an optimal cost structure that does not compromise performance, e.g. simultaneously cutting reagent costs while boosting sensitivity and robustness, can feel like an overwhelming challenge for diagnostic manufacturers. 

Adopting the strategies used for point-of-care testing, such as lyophilization, can both improve patient access and ease their cost burden. Adding lyophilization to your process adds more cost to the production process, true, but it can also reduce costs post-production through simplified storage and shipping logistics. Additionally, the lyophilization process itself can often be made more efficient through the use of glycerol-free, high concentration reagents. These are just a few examples; taking the full scope of your organization’s costs into consideration, from production to result delivery, manufacturers can find additional savings to offset the higher cost and improve affordability for patients.

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Developing an assay for hepatitis?
 

Let's work together to develop accessible diagnostic assays for monitoring this silent killer, supporting our shared vision for a better world. Explore what options you have to create reliable assays through variation-tolerant reagents. As part of Roche, we are a leader in supplying innovative, high-quality raw materials and products to forward-thinking biopharma and diagnostic businesses. Together, we will streamline your operations, power your growth, and deliver better healthcare for all.

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References

  1. Hepatitis. Accessed June 19, 2023. https://www.who.int/health-topics/hepatitis#tab=tab_1
  2. WHO releases first-ever global guidance for country validation of viral hepatitis B and C elimination. Published 2021. https://www.who.int/news/item/25-06-2021-who-releases-first-ever-global-guidance-for-country-validation-of-viral-hepatitis-b-and-c-elimination
  3. Hepatitis C. Accessed June 23, 2023. https://www.who.int/news-room/fact-sheets/detail/hepatitis-c
  4. Hepatitis B. Accessed June 22, 2023. https://www.who.int/news-room/fact-sheets/detail/hepatitis-b
  5. Bréchot C. Polymerase chain reaction for the diagnosis of viral hepatitis B and C. Gut. 1993;34(2 Suppl):S39. doi:10.1136/GUT.34.2_SUPPL.S39
  6. Testing for hepatitis C | Hepatitis C Trust. Accessed June 21, 2023. http://www.hepctrust.org.uk/information/testing/testing-hepatitis-c
  7. HCV RNA PCR: How This Hepatitis C Virus Test Works, Results, More. Accessed June 21, 2023. https://www.healthline.com/health/hepatitis-c/hcv-rna-pcr
  8. Hepatitis B Foundation: Additional Hepatitis B Blood Tests. Accessed June 21, 2023. https://www.hepb.org/prevention-and-diagnosis/diagnosis/other-tests/
  9. Bregenzer Andrea, Warmann Nicole, Ottiger Cornelia FCA. Rapid point-of-care HCV RNA quantification in capillary whole blood for diagnosing chronic HCV infection, monitoring treatment and detecting reinfection. Swiss Medical Weekly. doi:10.4414/smw.2019.20137
  10. Nasir Riaz M, Faheem M, Anwar MA, et al. PCR-Based Molecular Diagnosis of Hepatitis Virus (HBV and HDV) in HCV Infected Patients and Their Biochemical Study. J Pathog. Published online 2016:1-8. doi:10.1155/2016/3219793
  11. Al-Sadeq DW, Taleb SA, Zaied RE, et al. Hepatitis B Virus Molecular Epidemiology, Host-Virus Interaction, Coinfection, and Laboratory Diagnosis in the MENA Region: An Update. Pathog 2019, Vol 8, Page 63. 2019;8(2):63. doi:10.3390/PATHOGENS8020063
  12. Behzadi P, Ranjbar R, Alavian SM. Nucleic Acid-Based Approaches for Detection of Viral Hepatitis. Jundishapur J Microbiol. 2015;8(1):17449. doi:10.5812/jjm.17449
  13. Xiao Y, Thompson AJ, Howell J. Point-of-Care Tests for Hepatitis B: An Overview. Cells. 2020;9(10):2233. doi:10.3390/cells9102233
  14. Kojabad AA, Farzanehpour M, Galeh HEG, et al. Droplet digital PCR of viral ‎DNA/RNA, current progress, challenges, and future perspectives. J Med Virol. 2021;93(7):4182-4197. doi:10.1002/JMV.26846
  15. Kar P, Karna R. A Review of the Diagnosis and Management of Hepatitis E. Curr Treat Options Infect Dis

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