DBS Evaluation of Fujirebio INNOTEST® HCV Ab IV

NCT04317729 | Completed

• 1 other identifier: HC016
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Hepatitis C Virus Infection

Outcome Measures

Primary Outcomes (2)

• Sensitivity and specificity of fingerstick whole blood DBS

  Point estimates of sensitivity and specificity (with 95% confidence intervals) of the Fujirebio INNOTEST® HCV Ab IV assay in fWB collected on DBS, using EDTA plasma results obtained with the Fujirebio INNOTEST® HCV Ab IV assay as reference standard

  4 months

• Sensitivity and specificity of venous whole blood DBS

  Point estimates of sensitivity and specificity (with 95% confidence intervals) of the Fujirebio INNOTEST® HCV Ab IV assay in vWB collected on DBS, using EDTA plasma results obtained with the Fujirebio INNOTEST® HCV Ab IV assay as reference standard

  4 months

Secondary Outcomes (6)

• Degree of agreement of undiluted samples fWB and vWB

  4 months

• Degree of agreement of undiluted samples vWB and plasma

  4 months

• Degree of agreement of undiluted samples fWB and plasma

  4 months

• Degree of agreement of serial diluted samples fWB and vWB

  4 months

• Degree of agreement of serial diluted samples vWB and plasma

  4 months

Study Arms (1)

Diagnostic

EXPERIMENTAL

Collection of whole blood via fingerstick and venipuncture

Device: Fujirebio INNOTEST® HCV Ab IV assay

Interventions

Fujirebio INNOTEST® HCV Ab IV assay DEVICE

Enzyme Immunoassay

Diagnostic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead

Study Sites (2)

Astar Medical Centre

Lviv, 79000, Ukraine

Location

Lviv Regional Public Health Centre

Lviv, 79026, Ukraine

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Marta Vasylyev, MD

  Medical Centre Astar

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: March 23, 2020
• Study Start: January 30, 2020
• Primary Completion: April 30, 2020
• Study Completion: May 31, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

UA (2)