Influenza Viral Infections, RSV Infection
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTRoche Cobas® Liat Influenza A/B & RSV assay
Performance of a rapid molecular assay to diagnose influenza and RSV infections
Sponsors
LHUB-ULB
Roche Diagnostics GmbH
Erasme University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Either a pre-test indication of hospitalization * or an underlying situation at risk of respiratory complication following influenza infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analytical performance (Sensitivity/Specificity) | through study completion, 6 months | 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). |
| Hospital admission intentions | through study completion, 6 months | Number of admission intentions before and after the test result |
| Isolation intentions | through study completion, 6 months | Number of isolation intentions before and after the test result |
| Antibiotic prescription intentions | through study completion, 6 months | Number of antibiotic prescription intentions before and after the test result |
| Antiviral treatment prescription intentions | through study completion, 6 months | Number of antiviral treatments prescription intentions before and after the test result |
Countries
Belgium
Outcome results
None listed