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DBS Evaluation of Fujirebio INNOTEST® HCV Ab IV

NCT04317729 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2020-07-07

No results posted yet for this study

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.

Conditions

  • Hepatitis C Virus Infection

Interventions

DEVICE

Fujirebio INNOTEST® HCV Ab IV assay

Enzyme Immunoassay

Sponsors & Collaborators

  • Foundation for Innovative New Diagnostics, Switzerland

    lead OTHER

Principal Investigators

  • Marta Vasylyev, MD · Medical Centre Astar

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-30
Primary Completion
2020-04-30
Completion
2020-05-31

Countries

  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04317729 on ClinicalTrials.gov