Diagnosis of Respiratory Viruses in Children With Rhinoswab Junior
Condition: SARS CoV 2 Infection; COVID-19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      A study to investigate Rhinoswab as an alternative method to combined throat and deep nasal
      (CTDN) swab for respiratory sample collection in children who present to the Royal Children's
      Hospital (RCH) for viral testing. Children and their parent/guardian will answer a short
      survey about their preferences. Laboratory staff will answer a short survey about handling
      the different samples.
    

Detailed description: 
      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 (Therapeutic Goods Administration) 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 (Victorian
      Infectious Diseases Reference Laboratory) 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 the following in children 5-18 years of age:

        -  To determine the sensitivity and specificity of the Rhinoswab compared to the standard
           CTDN swab, in detecting viruses on the respiratory panel

        -  To determine whether Rhinoswab is non-inferior to the standard CTDN swab by comparing Ct
           values

        -  To determine the sensitivity and specificity of the throat swab alone and deep nasal
           swab alone, compared with the CTDN, in detecting respiratory viruses

        -  To investigate the comfort and preference of the Rhinoswab compared to the CTDN swab.

        -  To investigate the laboratory handling of the Rhinoswab compared to the CTDN swab.

        -  To determine the sensitivity and specificity of the Rhinoswab compared to CTDN swab, and
           saliva, in detecting respiratory viruses including SARS-CoV-2.

      In children 1 month to 5 years:

      • To investigate sensitivity and specificity of Rapid Antigen Test (RAT) compared to CTDN
      swab and saliva test in detected SARS-CoV-2
    

Intervention name(s): Rhinoswab Junior; Combined nose and throat swab; Saliva swab; Abbott Panbio™ COVID-19 antigen self-test kit
Intervention type(s): Device; Device; Device; Diagnostic Test
Intervention description(s): Rhinoswab Junior is a single use self-administered nasal swab intended to collect clinical specimens from the patient's nasal passages; Combined nose and throat swab (standard of care); Saliva swab; COVID-19 antigen self-test kit for the screening of active COVID-19 infection. It is a single-use, in vitro, visually read rapid immunoassay that uses a human nasal swab specimen for the qualitative detection of nucleocapsid protein SARS-CoV-2 antigen. It is intended to be used manually by untrained lay users (self testing) in a private setting.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study is organised sequentially into three phases due to research capacity
Phase 1: The first 250 participants (5-18 years) will be randomly assigned to Arm 1 and Arm 2 for the clinician collected/supervised phase.
Phase 2: 50 participants (5-18 years) will be allocated to Arm 3 for the self-collected Rhinoswab/saliva/combined nose+throat swab.
Phase 3: 50 subsequent participants (1m - 5 years) will be allocated to Arm 4 for the self-collect throat+nose/saliva/RAT
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Rhinoswab Junior