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Analytical Performances and Clinical Impact of the Roche Cobas® Liat Influenza A/B & RSV Assay in the Management of Adult and Pediatric Patients Attending the Emergency Room

NCT05105191 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2021-11-03

No results posted yet for this study

Summary

Molecular techniques for respiratory virus detection have already shown benefits in terms of sensitivity gained in comparison to conventional techniques. Recent progress has made it possible to shorten turnaround time (TAT) and to allow delivery of results in a timely manner, especially in comparison to cell culture and direct fluorescence assays (DFA). However, the cost of these molecular assays is usually not taken in charge by public health insurance system. This could be partly explained by the fact that molecular techniques have not clearly shown cost-effectiveness. Results of molecular tests for influenza viruses and RSV, if delivered rapidly, in the emergency room (ER), would most likely help avoid antibiotic use and ancillary test prescription, improve antiviral prescription and shorten length of stay in the ward by facilitating discharge or cohorting of hospitalized patients. The goal of this study is to assess the performances of Roche Cobas® Liat Influenza A/B \& RSV assay, to appraise its clinical impact and to evaluate its cost effectiveness.

Conditions

  • Influenza Viral Infections
  • RSV Infection

Interventions

DIAGNOSTIC_TEST

Roche Cobas® Liat Influenza A/B & RSV assay

Performance of a rapid molecular assay to diagnose influenza and RSV infections

Sponsors & Collaborators

  • LHUB-ULB

    collaborator UNKNOWN

  • Roche Diagnostics GmbH

    collaborator INDUSTRY

  • Erasme University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-03
Primary Completion
2020-03-09
Completion
2020-06-30
FDA Device
Yes

Countries

  • Belgium

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 NCT05105191 on ClinicalTrials.gov