Clinical trial NCT05946538: Clinical Evaluation of SARS-COV-2 (COVID-19), Influenza and RSV 8-Well MT-PCR Panel for In Vitro Diagnostics
Official title: Clinical Evaluation of SARS-COV-2, Influenza and RSV 8-Well MT-PCR Panel for In Vitro Diagnostics
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: AusDiagnostics Pty Ltd.
Sponsor class: INDUSTRY
First posted: 2023-07-14
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective accuracy observational study
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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