DBS Evaluation of Fujirebio INNOTEST® HCV Ab IV

NCT ID: NCT04317729

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-30
• Study Completion Date: 2020-05-31

Brief Summary

The goal of this trial is to evaluate the performance of the Fujirebio INNOTEST® HCV Ab IV using simpler collection methods such as fingerstick and venous whole blood collection on dried blood spots (DBS). In order to assess performance in samples with high and low antibody titres, performance will be evaluated with undiluted samples of all trial participants and serial diluted samples for a subset of HCV antibody reactive samples. Serial dilution of reactive samples will provide further insights into the potential difference of sensitivity in samples collected on DBS versus plasma.

Results of this trial will also support the update of the regulatory claims to include DBS as an alternative sample type.

Detailed Description

Access to Hepatitis C virus (HCV) screening in resource-limited settings should be enabled not only through the provision of point-of-care screening tests, but also through the possibility of collecting samples in decentralized settings One possible way of decentralizing sample collection is collecting dried blood spot (DBS) specimens, which can be easily transported to testing laboratories, not requiring any cold chain or complex sample transportation. DBS serology screening is complementary to established point-point-of care screening with rapid diagnostic tests, both methodologies being somewhat less cost-effective and less sensitive compared to lab-based methods but suitable for settings without sophisticated infrastructure.

To date, no HCV antibody serology test is formally evaluated for the use with DBS, however several studies on off-label use of DBS in serology screening assays, suggests that this sample type can serve as an alternative to plasma and serum. Fujirebio's enzyme immunoassay (EIA) INNOTEST® HCV Ab IV is CE marked and has received pre-qualification by the World Health Organization (WHO) for the use with venous plasma and serum, which require special equipment for sample collection, sample preparation and temperature controlled transportation.

Available data on the performance of HCV antibody detection from DBS samples are insufficient to introduce their use in clinical practice. Fujirebio is one of the few manufacturers who have an EIA test pre-qualified by the WHO for the use with plasma and serum to detect anti-HCV antibodies. A prospective diagnostic accuracy trial of the Fujirebio INNOTEST® HCV Ab IV assay in fWB and vWB collected on DBS, using EDTA plasma results obtained with the Fujirebio INNOTEST® HCV Ab IV assay as reference standard is needed to understand the relationship between results generated in plasma and WB samples collected on DBS. Furthermore, the data generated can be used by Fujirebio to update their regulatory claims and include DBS as an alternative sample type.

Conditions

Hepatitis C Virus Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic

Collection of whole blood via fingerstick and venipuncture

Group Type: EXPERIMENTAL

Fujirebio INNOTEST® HCV Ab IV assay

Intervention Type: DEVICE

Enzyme Immunoassay

Interventions

Fujirebio INNOTEST® HCV Ab IV assay

Enzyme Immunoassay

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Aged ≥18 years
• Provision of written informed consent
• Routine RDT reactive or non-reactive and recruitment target not yet met
• No history of HCV treatment

Exclusion Criteria

• Unwilling to provide required volume of fingerstick blood and venous whole blood
• Participants already enrolled in the trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Foundation for Innovative New Diagnostics, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marta Vasylyev, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Centre Astar

Locations

Astar Medical Centre

Lviv, , Ukraine

Lviv Regional Public Health Centre

Lviv, , Ukraine

Countries

Ukraine

Other Identifiers

HC016

Identifier Type: -

Identifier Source: org_study_id