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

NCT05946538 | Unknown

• 1 other identifier: AUS-RES-01
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Respiratory Viral Infection

Keywords

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

Outcome Measures

Primary Outcomes (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.

  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).

  6 months

Study Arms (1)

Device accuracy observational arm

OTHER

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; Diagnostic Test: BioFire Respiratory Panel 2.1

Interventions

SARS-COV-2, Influenza and RSV 8-Well MT-PCR Panel DIAGNOSTIC_TEST

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.

Device accuracy observational arm

BioFire Respiratory Panel 2.1 DIAGNOSTIC_TEST

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.

Device accuracy observational arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AusDiagnostics Pty Ltd.: lead

Central Study Contacts

Joanna Haydar

CONTACT

+61 432 683 964; Joanna.Haydar@ausdx.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective accuracy observational study

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: July 14, 2023
• Study Start: July 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: July 14, 2023

Record last verified: 2023-07