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Pandemic Preparedness Capabilities

A multi-virus assay on dried blood spots (DBS): a powerful tool for enhanced screening and prevention of hepatitis.


PI(s)/Head responsible for the resource:

Claudia Fredolini

Host organisation(s):

KTH Royal Institute of Technology

Resource description:

Chronic viral hepatitis represents a public health burden causing an estimated 1.4 million deaths annually and afflicting at the present, more than 350 million persons worldwide. Hepatitis B virus (HBV), hepatitis C virus (HCV) and hepatitis D virus (HDV) infection are a major cause of chronic viral hepatitis and liver diseases such as cirrhosis and hepatocellular carcinoma. The World Health Organization (WHO) aims to eliminate chronic viral hepatitis by 2030. In order to minimize viral transmission and to prevent further spread of the disease testing and monitoring will be a key factor. The goal the project is to develop a patient-centric strategy to enhance wide-population testing, in particular to reach high-risk groups. A multi- antigen hepatitis assays will be developed and optimized Specific aims include:

  • Development and analytical validation of multi-hepatitis virus test for detection of HBsAg/HCV/HDV antigen and antibodies on quantitative dried blood spot (qDBS) specimens.
  • Validation of test performance on clinical samples. The analytical and clinical performance of the screening method is evaluated on 200 samples from the large clinical biobank as part of Stockholms Medicinska Biobank (SMB).
  • Assessment of clinical feasibility and clinical utility. A small pilot study of feasibility including 100 individuals (50 positive and 50 negative), from the InfCare hepatitis Swedish register, will be performed to clinical specificity and sensitivity.
Research findings:

Viral hepatitis is an inflammation of the liver caused by a viral infection. There are five main strains of the hepatitis virus. While A and E viruses typically cause acute infections, hepatitis B, C, and D viruses are responsible for acute and chronic infections, being chronic hepatitis D the most severe form. Groups at high risk for hepatitis in European countries includes people who inject drugs (PWID), recipients of hemodialysis or multiple blood transfusions, commercial sex workers, home-less, incarcerated and migrants from high-endemic regions are the people that would need frequent testing the most, however unfortunately they represent a very hard to reach population. At the Affinity Proteomics Stockholm (APS) unit we are developing a test for the diagnosis of hepatitis, based on non-invasive dried blood spot sampling. The in-vitro test, uses beads coupled to antibodies anti hepatitis antigens or hepatitis antigens themselves. Bead based assay offer the opportunity to test for multiple proteins at the time, enabling us to develop a unique test for the diagnosis of hepatitis B, C, and D in the same sample. However the reagents used to measure the different viruses need to be carefully evaluated and so the possible interactions among them , which may cause false results. In the past months, we have tested a number of affinity reagents to identify a combination that work. We are now starting to work with our colleagues at the Therapeutic Protein Engineering (TPE) to develop high quality reagents for our test. With our collegues at Karolinska Institutet and Karolinska University, we are planning a test of the method on real blood samples (both regular serum and DBS) from people with and without hepatitis, using samples form the Swedish registry currently stored in biobanks and hospitals and a pilot study with Hepatitis patients to see if the DBS is acceptable to them as a method to collect samples and if the test is able to measure viral proteins in DBS samples as well as in serum, as serum is currently the sample type used in clinic to test individuals.

Impact on prepardness for future pandemics:

The method proposed responds to a currently high important need stated by the World Health Organization (WHO) to eliminate chronic viral hepatitis by 2030. Early diagnosis could prevent further spreading of the disease end eventually lead its elimination However, testing rate is still very limited, even in EU countries with good healthcare facilities of easy access, such as Sweden. This especially valid for high-risk vulnerable populations as migrants, persons with intravenous drug use, or persons in remote areas. There is a clinical problem of obtaining venous puncture samples especially in persons with intravenous drug use with low testing rate, and therefore an urgent need for a simple test method which could be used for home-testing or at sites with high prevalence of risk groups, covering of all pathogens of HBV/HDV and HCV.

Contact information:

Claudia Fredolini
Researcher
Email: claudia.fredolini@scilifelab.se