Respiratory Tract Infection Viral
Conditions
Keywords
Viral respiratory tract infection, Diagnostic test performance, Molecular diagnostic, Influenza, RSV, Rhinovirus
Brief summary
The goal of this observational study is to validate the use of less invasive samples (saliva, orobuccal or nasal swabs) than nasopharyngeal swab for testing common and clinically relevant respiratory viruses in children and adults presenting to an emergency departements with symptoms compatible with respiratory tract infection. The main question it aims to answer is: \- Is the precision of reverse transcription polymerase chain reaction (RT-PCR) for Influenzavirus A or B, respiratory syncytial virus (RSV), and Rhinovirus, on saliva, orobuccal swabs and nasal swabs comparable to the gold standard nasopharyngeal swab in a pediatric and adult population presenting with symptoms compatible with respiratory tract infection. Among participants the following samples will be collected (nasopharyngeal swab is standard of care and not part of the study samples): * Saliva * Orobuccal swab * Nasal swab
Interventions
DIAGNOSTIC_TESTRT-PCR in different respiratory tract samples
RT-PCR on saliva, orrobuccal swab and nasal swab will be performed. Nasopharyngeal swab will be performed independently of the study as standard of care.
Sponsors
University of Bern
Roche Diagnostics GmbH
Insel Gruppe AG, University Hospital Bern
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients presenting at the emergency departments or hospitalized at Inselspital Bern university hospital with any symptom compatible with an acute respiratory tract infection in whom a nasopharyngeal swab to test for respiratory viruses is performed (standard of care) * Written informed consent from the trial subject has been obtained; for patients aged 0-13 years, or not able to provide informed consent, consent obtained from the legal representative; for patients between 14-18 years, written informed consent obtained from the respective patient as well as the legal representative.
Exclusion criteria
* Patients unable to provide a saliva (e.g. patients with reduced level of consciousness). Children too young to be instructed to provide saliva are not excluded, but saliva won't be collected. * Patients with swallowing disturbances * Patient's lack of accountability and inability to appreciate the nature, meaning and consequences of the study and to formulate his/her own wishes correspondingly AND legal representative not available.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity of RT-PCR for Influenzavirus A or B, RSV and Rhinovirus, on orobuccal or nasal swab and saliva compared to nasopharyngeal swab. | At baseline |
| Specificity of RT-PCR for Influenzavirus A or B, RSV and Rhinovirus, on orobuccal or nasal swab and saliva compared to nasopharyngeal swab. | At baseline |
Secondary
| Measure | Time frame |
|---|---|
| Negative agreement between viral copy number of RT-PCR for Influenzavirus A or B, RSV, and Rhinovirus, Parainfluenzavirus, Adenovirus, human Metapneumovirus in saliva, orobuccal swabs and nasal swabs compared to nasopharyngeal swabs. | At baseline |
| Prevalence of respiratory viruses in orobuccal, nasal or nasopharyngeal swabs and saliva. | At baseline |
| Sensitivity of RT-PCR for Parainfluenzavirus, Adenovirus and human Metapneumovirus in orobuccal, nasal and saliva samples. | At baseline |
| Specificity of RT-PCR for Parainfluenzavirus, Adenovirus and human Metapneumovirus in orobuccal, nasal and saliva samples. | At baseline |
| Area under the receiver operating characteristic (ROC) curve for the detection of Influenza A/B, RSV and Rhinovirus in each study sample (orobuccal or nasal swab and saliva). | At baseline |
| Co-prevalence of respiratory viruses in orobuccal, nasal or nasopharyngeal swabs and saliva. | At baseline |
| Association between predefined symptoms and probability for positive RT-PCR of specific viruses using different (nasopharyngeal, orobuccal, nasal, saliva) samples. | At baseline |
| Comparative cycling time values at the different sampling locations | At baseline |
| Incremental yield of virus detection in orobuccal, nasal and saliva as compared to nasopharyngeal samples. | At baseline |
| Positive agreement between viral copy number of RT-PCR for Influenzavirus A or B, RSV, and Rhinovirus, Parainfluenzavirus, Adenovirus, human Metapneumovirus in saliva, orobuccal swabs and nasal swabs compared to nasopharyngeal swabs. | At baseline |
Countries
Switzerland
Outcome results
None listed