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LIAISON NES Influenza (FLU) A/B, Respiratory Syncytial Virus (RSV), & Coronavirus Disease 2019 (COVID-19) in Symptomatic Patients in Australia
Sponsor: DiaSorin Molecular LLC
Summary
To establish the relative accuracy of the LIAISON® NES Flu A/B, RSV \& COVID-19 assay for viral nucleic acid targets from professionally collected or patient self-collected dry nasal (NS) swabs and to establish the relative accuracy of the LIAISON PLEX® RSP Flex assay from NS and nasopharyngeal swabs (NPS) in applicable transport media from human patients exhibiting clinical signs and symptoms of a respiratory tract infection.
Official title: A Multi-Site Clinical Evaluation of the LIAISON NES FLU A/B, RSV, & COVID-19 and LIAISON PLEX Respiratory (RSP) Flex Assays in Symptomatic Patients in Australia
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2024-05-06
Completion Date
2024-10-31
Last Updated
2024-04-30
Healthy Volunteers
No
Conditions
Interventions
LIAISON NES FLU A/B, RSV, & COVID-19
The LIAISON® NES FLU A/B, RSV \& COVID-19 real-time (RT) PCR assay is a Point of Care (POC) system that enables the extraction, amplification, detection and differentiation of influenza A, Influenza B, respiratory syncytial virus (RSV) and SARS-CoV-2 viral RNA from dry nasal swabs (NS). The system consists of the LIAISON® NES FLU A/B, RSV \& COVID-19 cartridge, the LIAISON® NES system (with LIAISON® NES Software), and associated accessories. In the LIAISON® NES FLU A/B, RSV \& COVID-19 cartridge, extraction reagents and lyophilized fluorescent probes are used together with corresponding forward and reverse primers to extract and amplify influenza A, influenza B, RSV, SARS-CoV-2 and internal control RNA targets.
LIAISON PLEX Respiratory Flex Assay
The LIAISON PLEX® (also known as VERIGENE® II) RSP Flex Assay is an automated test for the detection and identification of common viruses and bacteria, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA, from upper respiratory specimens. The VERIGENE® II Respiratory Flex (RSP Flex) Assay is performed on the VERIGENE® II System. The VERIGENE® II System is an automated platform that performs sample preparation and is capable of polymerase chain reaction (PCR) for the detection of target-specific nucleic acids. The VERIGENE® II System is a fully automated, bench-top "sample-to-answer" device. The test reagents are supplied in a single, disposable test cartridge.
Locations (4)
Key Health - Bondi
Bondi Junction, New South Wales, Australia
Key Health - CBD South
Sydney, New South Wales, Australia
Key Health - Pagewood
Sydney, New South Wales, Australia
Maxwell Medical Group
Melbourne, Victoria, Australia