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Clinical Evaluation of SARS-COV-2 (COVID-19), Influenza and RSV 8-Well MT-PCR Panel for In Vitro Diagnostics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05946538
Recruitment Status : Not yet recruiting
First Posted : July 14, 2023
Last Update Posted : July 14, 2023
Sponsor:
Information provided by (Responsible Party):
AusDiagnostics Pty Ltd.

Study Description
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Brief Summary:
This study is a prospective accuracy observational study to evaluate the performance of the Highplex System SARS-Cov-2, Influenza and RSV 8-well in vitro diagnostic medical device panel and generate performance data. The precision of results will be evaluated in concordance with the comparator predicate device panel BioFire Respiratory Panel 2.1 (RP2.1).

Condition or disease Intervention/treatment Phase
Respiratory Viral Infection Diagnostic Test: SARS-COV-2, Influenza and RSV 8-Well MT-PCR Panel Diagnostic Test: BioFire Respiratory Panel 2.1 Not Applicable

Detailed Description:
This study is a prospective accuracy observational study to evaluate the performance of the Highplex System SARS-Cov-2, Influenza and RSV 8-well in vitro diagnostic medical device panel and generate performance data. The precision of results will be evaluated in concordance with the comparator predicate device panel BioFire Respiratory Panel 2.1 (RP2.1). This study will utilise prospective sample respiratory swabs from individuals with paired test data, presenting with influenza-like symptoms (e.g., cough, nasal congestion, rhinorrhoea, sore throat, fever, headache, myalgia), as well as asymptomatic individuals. To meet the target number of 400 positive samples (50 samples per target; 8 targets in total), a required sampling size of 1000 participants will need to be screened to account for unviable samples and screen failures. Prospective respiratory samples will include nasopharyngeal swabs as described in Intended Use of the product.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective accuracy observational study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of SARS-COV-2, Influenza and RSV 8-Well MT-PCR Panel for In Vitro Diagnostics
Estimated Study Start Date : July 2023
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arms and Interventions
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Arm Intervention/treatment
Device accuracy observational arm
Two nasopharyngeal swabs will be collected from each enrolled participant and analysed on the AusDiagnostics in vitro diagnostic device panel and the comparator BioFire in vitro diagnostic device panel.
 Diagnostic Test: SARS-COV-2, Influenza and RSV 8-Well MT-PCR Panel
The SARS-CoV-2, Influenza and RSV PCR test is multiplex-tandem polymerase chain reaction (MT-PCR) based on qualitive in vitro diagnostic testing for the detection and identification of pathogens in nucleic acid extracts.

Diagnostic Test: BioFire Respiratory Panel 2.1
The BioFire Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BioFire® FilmArray® 2.0 or BioFire® FilmArray® Torch Systems for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with positive samples as evaluated by the AusDiagnostics SARS-COV-2, Influenza and RSV 8-Well MT-PCR Panel and the BioFire Respiratory Panel 2.1. [ Time Frame: 6 months ]
    The study will be considered to have reached its primary endpoint when performance data from 50 positive samples for each panel target has been collected and evaluated for precision and concordance with the comparator predicate device panel BioFire Respiratory Panel 2.1 (RP2.1).


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The sample is derived from an individual who has the ability to provide consent or from a legally acceptable representative, parent(s), or legal guardian and have consented for their sample and demographic information to be taken
  • The sample is a nasopharyngeal swab
  • The sample is collected in universal transport media (UTM) or viral transport media (VTM), using FDA approved swabs
  • The sample is collected from an individual who has a presumptive diagnosis or is presenting with influenza-like symptoms (e.g., cough, nasal congestion, rhinorrhoea, sore throat, fever, headache, myalgia) or is suspected to be asymptomatic.

Exclusion Criteria:

  • Sample does not meet acceptable specimen criteria in that is not a nasopharyngeal swab
  • The sample is collected using swabs with wood shafts or other materials known to inhibit growth of influenza viruses
Contacts and Locations
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Information from the National Library of Medicine

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): NCT05946538


Contacts
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Contact: Joanna Haydar +61 432 683 964 Joanna.Haydar@ausdx.com

Sponsors and Collaborators
AusDiagnostics Pty Ltd.
More Information
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Responsible Party: AusDiagnostics Pty Ltd.
ClinicalTrials.gov Identifier: NCT05946538    
Other Study ID Numbers: AUS-RES-01
First Posted: July 14, 2023    Key Record Dates
Last Update Posted: July 14, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AusDiagnostics Pty Ltd.:
In vitro Diagnostic Device
In vitro Diagnostic
Multiplexed Tandem Polymerase Chain Reaction
Respiratory Panel
 Respiratory Syncytial Virus
Severe Acute Respiratory Syndrome Coronavirus 2
Influenza Virus
Additional relevant MeSH terms:
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Influenza, Human
Virus Diseases
Respiratory Tract Infections
Infections
 Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases