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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Influenza Viral Infections, RSV Infection

Intervention / Treatment
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* Diagnostic Test: Roche Cobas® Liat Influenza A/B & RSV assay


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Either a pre-test indication of hospitalization or an underlying situation at risk of respiratory complication following influenza infection
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Roche Cobas® Liat Influenza A/B & RSV assay|Performance of a rapid molecular assay to diagnose influenza and RSV infections|

What is the study measuring?
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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 |