Determination of New Detection and Quantification Thresholds for Serological and Molecular Tests for Hepatitis Delta Virus (HDV) Using Capillary Blood on Blotting Paper (DBS)

NCT06649396 | Not Yet Recruiting

• 1 other identifier: IMEA
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The Delta hepatitis virus (HDV) is a satellite virus that requires the presence of hepatitis B virus (HBV) for infection. Approximately 5% of HBV-infected individuals, or about 12 million people globally, are also carriers of HDV. This dual infection significantly heightens the risk of liver damage and the progression to hepatocellular carcinoma (HCC). Historically, the diagnosis of HDV has been limited, leading to an underestimation of its true prevalence both nationally and internationally. Recent advancements in treatments for viral hepatitis and the introduction of new HDV-specific therapies have spurred increased interest in the virus, prompting public health authorities to call for improved diagnostic and monitoring tools. Detection of HDV typically involves serological tests (ELISA/CLIA) on serum or plasma, followed by viral load quantification using RT-qPCR if positive. However, laboratory access is often insufficient in many regions, particularly affecting marginalized populations and high-endemic areas, especially in low-resource countries. New sample collection methods that help connect patients to expert laboratories are needed, as shipping frozen biological samples can be complex and costly. In response, Dried Blood Spot (DBS) sampling-where serum, plasma, or whole blood is dried on filter paper-has been adopted by numerous public health organizations as a simple, cost-effective, and non-infectious means of storage and transport. DBS is already validated for diagnosing and monitoring infections such as HIV, HBV, and HCV. Given the unique biology of each virus, specific studies are required to determine how using DBS affects detection and quantification thresholds for each laboratory technique. The National Reference Center for Delta Hepatitis (CNR-Delta), commissioned by Public Health France, has developed a DBS protocol for HDV, based on available literature and prior studies regarding storage conditions and reconstitution solutions. Two retrospective studies utilizing CNR collections have established new positivity thresholds for serology and detection/quantification in molecular biology for serum/plasma and EDTA whole blood on DBS. To finalize this protocol, further study of thresholds for capillary blood tests on DBS is essential. Capillary blood, obtained via finger prick, could simplify the use of this tool, reducing the need for specialised equipment and expertise, and potentially allowing for self-sampling by patients. The current study aims to validate the DBS tool for HDV serological and molecular testing using capillary blood. The hypothesis posits that geographical barriers to accessing hospitals and laboratories for HDV patients complicate the shipping of frozen plasma samples, increasing costs. Developing a serological screening and viral load testing technique from a drop of capillary blood on DBS paper could effectively link patients to specialized centers. Since DBS is considered non-infectious, it also mitigates administrative complications. By comparing results from paired samples-plasma (the gold standard) from EDTA whole blood and capillary blood on DBS-we aim to redefine detection and quantification thresholds for both methods. Validating these new thresholds will allow the use of this tool while maintaining quality standards for diagnosing and monitoring active HDV infections.

Conditions

Delta Hepatitis

Keywords

Dried Blood Spot; DBS; Delta Hepatitis; HDV; Viral load; Serology

Outcome Measures

Primary Outcomes (2)

• HDV serology

  Comparison between total anti-HDV antibody detection results on Diasorin Liaison XL on plasma obtained from peripheral blood (EDTA) and on capillary blood blotted onto filter paper.

  At enrollment

• HDV viral load

  Comparison between HDV viral load results obtained by RT-qPCR (Eurobioplex EBX-071) on plasma from peripheral blood (EDTA) and capillary blotted onto filter paper.

  At enrollment

Secondary Outcomes (1)

• Genotyping

  At enrollment

Study Arms (2)

Capillary Blood on DBS

EXPERIMENTAL

A total of 100µL of capillary blood will be deposited onto DBS

Diagnostic Test: Dried Blood Spot

Plasma from EDTA whole blood

EXPERIMENTAL

Plasma from peripheral blood

Diagnostic Test: Analysis on plasma

Interventions

Dried Blood Spot DIAGNOSTIC_TEST

Comparing analysis results between dried blood spot and plasma

Capillary Blood on DBS

Analysis on plasma DIAGNOSTIC_TEST

Analysis on plasma

Plasma from EDTA whole blood

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (18 years old and above)
• Patient infected by the Hepatitis Delta Virus (HDV positive serology)
• Patient followed by one of the participating APHP hospitals' hepatology department
• Patient for whom peripheral blood sampling is already planned as part of their medical follow-up.
• Free, informed and signed consent.

You may not qualify if:

• Patient without blood sampling scheduled as part of medical follow-up.
• Patient with a condition that makes fingertip capillary puncture impossible.
• Patient refusing to participate in the study

Sponsors & Collaborators

• Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba: lead
• CNR Hepatite Delta: collaborator

Study Sites (1)

Centre National de Référence associé de l'Hépatite Delta (CNR-Delta)

Bobigny, 93100, France

Location

MeSH Terms

Conditions

Hepatitis D

Interventions

Dried Blood Spot Testing

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Frederic Le Gal, PhD

CONTACT

01 48 95 74 03; frederic.legal@aphp.fr

Valérian Delagarde, MSc

CONTACT

01 48 95 55 55 Poste 52747; valerian.delagarde@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 18, 2024
• Study Start: November 30, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)