Sample Collection for Evaluation of the Panbio™ COVID-19/ Flu A&B Rapid Panel.
Condition: COVID-19; Influenza A; Influenza Type B
MeSH terms: COVID-19; Influenza, Human
Study type: Interventional

Summary: 
      This study is designed as a prospective, multicentric, sample collection study. The collected
      samples will be used for diagnostic research, product development and validation of the
      Panbio™ COVID-19/ Flu A&B Rapid Panel for the qualitative detection of COVID-19 antigen,
      Influenza A antigen (H1N1 and H3N2), and Influenza B antigen in human nasal and
      nasopharyngeal swabs by the study sponsor, Abbott.
    

Detailed description: 
      A minimum of 665 male and female Subjects will be prospectively enrolled at multiple clinical
      sites. A minimum of 90 Flu A reference positive subjects, a minimum of 90 Flu B reference
      positive subjects and a minimum of 100 SARS-CoV-2 reference positive subjects will be
      enrolled. In addition, a minimum of 385 reference-negative subjects will be enrolled. In
      order to meet these minimum numbers it is anticipated that approximately 2000 subjects will
      be enrolled in total.

      Subjects should be enrolled from point of care for this study. After informed consent has
      been obtained, operators will collect one nasal swab from both nostrils from each Subject.
      Every second subject will be asked to blow their nose first and this will be recorded.

      Collection procedure will be a mid-turbinate nasal swab (deep nasal swab), by turning the
      swab five times in each nostril.

      The collected swab will be returned to a plastic tube (provided by the sponsor) and
      immediately (or within 15 minutes of collection) stored frozen at -80°C (or -20°C if -80°C
      storage is not available) for later testing with the Panbio™ Rapid Panel. Touching of the
      tube wall with the swab should be avoided. Nasal samples must be collected prior to the
      Nasopharyngeal sampling.

      After the nasal sampling, the operators will collect a nasopharyngeal swab from one nostril
      of each subject. The NP swab will be returned to a plastic tube (provided by the sponsor) by
      study staff (touching the tube walls should be avoided) and immediately (or within 15 minutes
      of collection) stored frozen at -80°C (or -20°C if -80°C storage is not available) for later
      testing with the Panbio™ Rapid Panel.

      A second nasopharyngeal swab, collected from the other nostril of each subject will be eluted
      in Universal Transport Media (UTM) and used for testing with RT-PCR protocols for Flu A, Flu
      B and SARS-CoV-2 as per local procedures. The remaining UTM will be labelled with Subject ID
      and immediately stored frozen at -80°C (or -20°C minimum). The RT-PCR methods used must have
      CE marking or FDA approval, with COVID-19 and Flu assay clearance for nasopharyngeal
      specimens and must be approved by the Sponsor. Nasopharyngeal sampling should be performed by
      trained healthcare professionals who routinely conduct nasopharyngeal sampling as part of
      their other standard of care and clinical duties.

      All other aspects of the Subject's care will remain the same with no deviation from
      prescribed practice.

      Each subject's demographic information, symptomology data, and professionally performed test
      result and questionnaire will be recorded on source documentation and transferred to an
      Electronic Data Capture system.

      Samples collected in this study will be used for diagnostic research, product development and
      validation of the Panbio™ COVID-19/ Flu A&B Rapid Panel by the study sponsor, Abbott.
    

Intervention name(s): Nasal and Nasopharyngeal Sampling of the Panbio™ COVID-19/ Flu A&B Rapid Panel
Intervention type(s): Diagnostic Test
Intervention description(s): Collection procedure will be a mid-turbinate nasal swab (deep nasal swab), by turning the swab five times in each nostril. After the nasal sampling, the operators will collect two nasopharyngeal swab one from each nostril of each subject.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic