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Completed

NCT Number: NCT06743750

Comparison Between Different Sampling Sites for Detection of Respiratory Viruses

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

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Key information

Conditions

Respiratory Tract Infection Viral Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

0 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Inselspital, University Hospital of Bern

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RT-PCR in different respiratory tract samples

Diagnostic Test

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.

Primary outcomes

  1. 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

  2. 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

  1. 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

  2. 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

  3. 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

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

    Time frame: At baseline

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

    Time frame: At baseline

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

    Time frame: At baseline

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

    Time frame: At baseline

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

    Time frame: At baseline

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

    Time frame: At baseline

  10. Comparative cycling time values at the different sampling locations

    Time frame: At baseline

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Roche Diagnostics GmbH
  • University of Bern

Registry information

Official study title

Comparison Between Nasopharynx and Orobuccal/Nasal Swabs or Saliva for Detection of Respiratory Viruses (ORASAMP)

Acronym: ORASAMP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 20, 2024
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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