LIAISON NES Influenza (FLU) A/B, Respiratory Syncytial Virus (RSV), & Coronavirus Disease 2019 (COVID-19) in Symptomatic Patients in Australia

NCT06392451 | Not Yet Recruiting

• 1 other identifier: DSM-PROT-005190
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Influenza A; Influenza Type B; Coronavirus Disease 2019; Respiratory Syncytial Virus (RSV); Adenovirus; Enterovirus; Para Influenza; Bordetella Parapertussis Infection; Bordetella Pertussis Infection, Respiratory; Chlamydia Pneumonia; Mycoplasma Pneumonia

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy

  Estimates of Sensitivity/PPA and Specificity/NPA will be calculated based on a two-by-two table (comparator method result vs. result from LIAISON® NES FLU A/B, RSV \& COVID-19 assay or LIAISON PLEX® RSP Flex assay) for each target. In addition, 95% two-sided confidence intervals will be provided. A separate Sensitivity/PPA and Specificity/NPA for each target, to include those specimens excluded due to a discrepancy between the standard-of-care and molecular comparator result, will be presented in a separate 2 x 2 table.

  Samples will be tested on LIAISON NES within one hour of collection.

Study Arms (1)

Blinded, Prospective Arm

OTHER

Clinical specimens shall be collected prospectively from patients with signs or symptoms of respiratory tract infection. Nasal swab (NS) in Copan universal transport media (UTM) 3 milliliters for comparator testing should be collected by a healthcare professional. Where subjects are willing and able, up to 40% of NS for the investigational device will be self-collected under the guidance and supervision of a healthcare professional. Nasopharyngeal (NPS) specimens (optional) should only be collected by a healthcare professional. All specimens collected from children 13 years or younger should only be collected by a trained healthcare professional. Follow the Centers for Disease Control and Prevention guidelines for collecting NPS swabs, unless otherwise specified by the sponsor.

Diagnostic Test: LIAISON NES FLU A/B, RSV, & COVID-19; Diagnostic Test: LIAISON PLEX Respiratory Flex Assay

Interventions

LIAISON NES FLU A/B, RSV, & COVID-19 DIAGNOSTIC_TEST

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.

Blinded, Prospective Arm

LIAISON PLEX Respiratory Flex Assay DIAGNOSTIC_TEST

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.

Also known as: VERIGENE II

Blinded, Prospective Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Human patients with active signs and symptoms of respiratory tract infection at time of collection
• Specimens collected within 7 days of symptom onset for the initial collection
• Patient consents to participate in the study
• Availability of age, gender, race, ethnicity, collection dates, collection time, routine respiratory testing method, routine respiratory result, signs and symptoms (e.g., fever), date of symptom onset for each symptom, vaccination status (Flu and COVID-19, as applicable), pre-existing medical conditions (as applicable), medications (e.g., COVID-19 antivirals), etc. for each subject

You may not qualify if:

• Incorrect swab type
• Incorrect transport media
• Incorrect specimen handling (specimens not stored at recommended temperature)
• Samples collected \>7 days from symptom onset
• Subject does not provide informed consent or subject withdraws informed consent

Sponsors & Collaborators

• DiaSorin Molecular LLC: lead

Study Sites (4)

Key Health - Bondi

Bondi Junction, New South Wales, 2022, Australia

Location

Key Health - CBD South

Sydney, New South Wales, 2000, Australia

Location

Key Health - Pagewood

Sydney, New South Wales, 2036, Australia

Location

Maxwell Medical Group

Melbourne, Victoria, 3019, Australia

Location

MeSH Terms

Conditions

COVID-19; Adenoviridae Infections; Enterovirus Infections; Paramyxoviridae Infections; Whooping Cough; Psittacosis; Pneumonia, Mycoplasma

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; DNA Virus Infections; Picornaviridae Infections; Mononegavirales Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Chlamydophila Infections; Chlamydiaceae Infections; Mycoplasma Infections; Mycoplasmatales Infections; Pneumonia, Bacterial

Study Officials

• Janet Farhang, PhD

  DiaSorin Molecular/Luminex Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Behounek, PhD

CONTACT

512-336-3554; rbehounek@luminexcorp.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants are not provided investigational results and will only be provided with routine standard of care diagnostics results.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: April 30, 2024
• Study Start: May 6, 2024
• Primary Completion: August 31, 2024
• Study Completion: October 31, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

AU (4)