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Evaluation of Dried Blood Spot for HCV RNA Testing

NCT03896087 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 942

Last updated 2020-12-17

No results posted yet for this study

Summary

FIND is preparing a study to evaluate the performance, as measured by sensitivity and specificity, of four centralized assays for the detection of HCV RNA using capillary blood collected on dried blood spots (DBS) and plasma separation card (PSC).

Conditions

  • Hepatitis C, Chronic

Interventions

DIAGNOSTIC_TEST

Abbott RealTime HCV assay from DBS

The trial intervention will consist of testing DBS, PSC and plasma samples obtained from trial participants using the centralised molecular assays for detection of HCV RNA. Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.

DIAGNOSTIC_TEST

HCV for use on the cobas® 6800/8800 Systems from PSC and DBS

The trial intervention will consist of testing DBS, PSC and plasma samples obtained from trial participants using the centralised molecular assays cobas® 6800/8800 Systems for detection of HCV RNA. Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.

DIAGNOSTIC_TEST

Aptima® HCV Quant Dx Assay from DBS

The trial intervention will consist of testing DBS, PSC and plasma samples obtained from trial participants using the centralised molecular assays Aptima® HCV Quant Dx Assay from DBS for detection of HCV RNA. Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.

DIAGNOSTIC_TEST

HCV for use on the cobas® 4800Systems from PSC and DBS

The trial intervention will consist of testing DBS, PSC and plasma samples obtained from trial participants using the centralised molecular assays cobas® 4800 for detection of HCV RNA. Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.

Sponsors & Collaborators

  • UNITAID

    collaborator OTHER

  • Foundation for Innovative New Diagnostics, Switzerland

    lead OTHER

Principal Investigators

  • Elena Ivanova, Ph.D. · Foundation for Innovative New Diagnostics

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2020-11-30
Completion
2020-12-01

Countries

  • Australia
  • Cameroon
  • Georgia
  • Greece
  • Rwanda

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 NCT03896087 on ClinicalTrials.gov