NCT05946538

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, Influenza and RSV 8-Well MT-PCR Panel for In Vitro Diagnostics

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: AusDiagnostics Pty Ltd. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.
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.

Timeline

• Start date: 2023-07-01
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2023-07-14
• Last updated: 2023-07-14