Diagnosis of Respiratory Viruses in Children With Rhinoswab Junior
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|ClinicalTrials.gov Identifier: NCT05043623|
Recruitment Status : Recruiting
First Posted : September 14, 2021
Last Update Posted : September 14, 2021
|Condition or disease||Intervention/treatment|
|SARS CoV 2 Infection||Device: Rhinoswab Junior|
The microbiological test of choice for detection of respiratory viruses is a reverse transcription polymerase chain reaction (RT-PCR). The test is reported as "detected" or "not-detected" to the clinician. The Ct-value is a microbiological analysis that represents the number of amplification cycles required for a target gene to exceed a threshold level, to determine a negative or positive result and is interpreted to detect respiratory viruses. The Ct-value is used to measure viral load.
SARS-CoV-2, the virus that causes COVID-19, is a respiratory virus of specific interest. SARS-CoV-2 is detected in the upper respiratory tract. National guidelines for diagnosing COVID-19 in Australia require a combined throat and deep nasal swab (CTDN). No other testing options are routinely recommended in Australia. However, research and international guidelines recommend nasal swabs alone for SARS-CoV-2 detection. The Center for Disease Control and Prevention (USA) currently recommend the use of an anterior nasal swab alone as a method for detection of SARS-CoV-2. A recent systematic review suggested nasal swabs are a clinically acceptable alternative specimen collection methods. In addition to satisfactory diagnostic performance, nasal swabs are potentially less invasive, and can be self-collected.
Research at the Melbourne Children's Campus has identified that the CTDN or nasopharyngeal swab, are uncomfortable and distressing for children. The fear of the test is a barrier for presentation to a health service for a SARS-CoV-2 test. Parental and child reluctance to undergo testing may impact the public health response, through under-identification of pediatric cases.
The Rhinoswab is a TGA approved anterior nasal swab for children and adults. The design of the Rhinoswab allows for standardisation of the site of biological sampling, as compared with CTDN swabs which are operator dependent. It is designed to be more comfortable and to collect nasal secretions for PCR testing. The Rhinoswab Junior is a smaller paediatric version that has novelty features which add interest and distraction. The child can use the swab themselves, allowing autonomy and control. The capture and elution efficiency of the Rhinoswab has been shown to be comparable, if not slightly superior, to the capture and elution efficiency to the commercially available Copan eSwab by VIDRL and GNOMIX analyses.
The RCH has completed over 30,000 tests in children throughout the COVID-19 Pandemic from March 2020 to June 2021 at the Respiratory Infection Clinic and Emergency Department. The RCH nurses and doctors are well placed to trial the Rhinoswab due to extensive experience in testing children, and have developed related clinical practice guidelines.
This trial aims to determine if the Rhinoswab is as sensitive and specific as the standard CTDN swab, in detecting respiratory viruses, in children aged 4-18 years. This study also aims to understand which swab children prefer, and how the swabs compare when being handled in the laboratory.
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||Diagnosis of Respiratory Viruses in Children With Rhinoswab Junior|
|Actual Study Start Date :||August 26, 2021|
|Estimated Primary Completion Date :||October 26, 2021|
|Estimated Study Completion Date :||January 26, 2022|
- Device: Rhinoswab Junior
To determine the sensitivity and specificity of the Rhinoswab compared to the standard CTDN swab, in detecting viruses on the respiratory panel
- PCR ct value of viruses detected on respiratory panel of the Rhinoswab junior [ Time Frame: 3 months ]Rhinoswab junior sample will be tested with respiratory panel and CT value recorded
- PCR ct value of viruses detected on respiratory panel on standard of care (combined nose and throat) swab [ Time Frame: 3 months ]The standard of care test (combined nose/throat) will be tested for respiratory viruses and CT value recorded
- Comfort Assessment [ Time Frame: 3 months ]The comfort and preference of the Rhinoswab compared to the CTDN swab on a Likert Scale
- Laboratory Assessment [ Time Frame: 3 months ]Laboratory handling assessment of Rhinoswab compared to the CTDN swab on a Likert Scale
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05043623
|Contact: Shidan Tosif, MBBS FRACP PhDfirstname.lastname@example.org|
|Parkville, Victoria, Australia, 3052|
|Contact: Shidan Tosif 0413484876 email@example.com|