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

NCT ID: NCT05946538

Last Updated: 2023-07-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2024-02-29

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).

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.

Conditions

Respiratory Viral Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

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

Intervention Type: 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.

BioFire Respiratory Panel 2.1

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AusDiagnostics Pty Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Joanna Haydar

Role: CONTACT

Joanna.Haydar@ausdx.com

+61 432 683 964

Other Identifiers

AUS-RES-01

Identifier Type: -

Identifier Source: org_study_id