Comparison Between Different Sampling Sites for Detection of Respiratory Viruses

Insel Gruppe AG, University Hospital Bern501 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

501

Conditions

Respiratory Tract Infection Viral

Interventions

RT-PCR in different respiratory tract samplesDIAGNOSTIC_TEST

Eligibility

Sex: ALLMin age: 0 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Sensitivity of RT-PCR for Influenzavirus A or B, RSV and Rhinovirus, on orobuccal or nasal swab and saliva compared to nasopharyngeal swab.

Time frame: 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.

Time frame: At baseline

Secondary Outcomes

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).

Time frame: 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.

Time frame: At baseline

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.

Time frame: At baseline

Prevalence of respiratory viruses in orobuccal, nasal or nasopharyngeal swabs and saliva.

Time frame: At baseline

Sensitivity of RT-PCR for Parainfluenzavirus, Adenovirus and human Metapneumovirus in orobuccal, nasal and saliva samples.

Time frame: At baseline

Specificity of RT-PCR for Parainfluenzavirus, Adenovirus and human Metapneumovirus in orobuccal, nasal and saliva samples.

Time frame: At baseline

Incremental yield of virus detection in orobuccal, nasal and saliva as compared to nasopharyngeal samples.

Time frame: At baseline

Co-prevalence of respiratory viruses in orobuccal, nasal or nasopharyngeal swabs and saliva.

Time frame: At baseline

Association between predefined symptoms and probability for positive RT-PCR of specific viruses using different (nasopharyngeal, orobuccal, nasal, saliva) samples.

Time frame: At baseline

Comparative cycling time values at the different sampling locations

Time frame: At baseline

Comparison Between Different Sampling Sites for Detection of Respiratory Viruses

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes