NCT05105191

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: Erasme University Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Type	Name	Description
DIAGNOSTIC_TEST	Roche Cobas® Liat Influenza A/B & RSV assay	Performance of a rapid molecular assay to diagnose influenza and RSV infections

Timeline

• Start date: 2020-02-03
• Primary completion: 2020-03-09
• Completion: 2020-06-30
• First posted: 2021-11-03
• Last updated: 2021-11-03

Locations

4 sites across 1 country: Belgium

Regulatory

• FDA-regulated device study