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

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.

Study Overview

• Status: Terminated
• Conditions: RSV Infection; Influenza Viral Infections
• Intervention / Treatment: Diagnostic test: Roche Cobas® Liat Influenza A/B & RSV assay

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium
    • Brugmann hospital
  • Brussels, Belgium
    • Erasme Hospital
  • Brussels, Belgium
    • Huderf
  • Brussels, Belgium
    • Saint-Pierre Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Either a pre-test indication of hospitalization
• or an underlying situation at risk of respiratory complication following influenza infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analytical performance (Sensitivity/Specificity)	Calculation of sensitivity and specificity of the test versus a composite reference standard. Samples are considered as positive for a viral pathogen if testing positive for this viral pathogen by at least 2 of the 3 techniques used, negative if tested negative by at least 2 of the 3 techniques (culture, antigen detection and PCR test).	through study completion, 6 months
Hospital admission intentions	Number of admission intentions before and after the test result	through study completion, 6 months
Isolation intentions	Number of isolation intentions before and after the test result	through study completion, 6 months
Antibiotic prescription intentions	Number of antibiotic prescription intentions before and after the test result	through study completion, 6 months
Antiviral treatment prescription intentions	Number of antiviral treatments prescription intentions before and after the test result	through study completion, 6 months

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Collaborators: Roche Diagnostics; LHUB-ULB

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2020
• Primary Completion (Actual): March 9, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: October 21, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): November 3, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Paramyxoviridae Infections; Mononegavirales Infections; Orthomyxoviridae Infections; Pneumovirus Infections; Emergencies; Infections; Communicable Diseases; Virus Diseases; Influenza, Human; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: SRB2019_401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes