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

AusDiagnostics

Status: Not yet enrolling

Conditions: Respiratory Viral Infection

Treatments: Diagnostic Test: BioFire Respiratory Panel 2.1; Diagnostic Test: SARS-COV-2, Influenza and RSV 8-Well MT-PCR Panel

Study type: Interventional

Funder types: Industry

Identifiers

NCT05946538

AUS-RES-01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,000 participants in 1 patient group

Device accuracy observational arm

Other group

Description:

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.

Treatment:

Diagnostic Test: BioFire Respiratory Panel 2.1

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