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

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

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 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.

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

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.

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.

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.

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).

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