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ClinicalTrials.gov ID

NCT06392451

Lead Sponsor

DiaSorin Molecular LLCINDUSTRY

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

1,000Estimated

Last Update Posted

Apr 30, 2024Actual

Start Date

May 6, 2024Estimated

Primary Completion Date

Aug 31, 2024Estimated

Completion Date

Oct 31, 2024Estimated

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

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.

Detailed Description

This study is a clinical evaluation of two investigational devices on the same patient specimens:

• The LIAISON® NES FLU A/B, RSV & COVID-19 assay used for the detection and identification of influenza A, influenza B, RSV and SARS-CoV-2 on the LIAISON® NES system, developed by DiaSorin Molecular
• The LIAISON PLEX® RSP Flex assay used for the detection and identification of 19 common respiratory pathogens, including 14 viral and 5 bacterial targets on the LIAISON PLEX® system, developed by Luminex Corporation (a subsidiary of DiaSorin)

This study will utilize untrained operators to perform investigational device testing on the LIAISON NES platform, and as such instrument or assay-specific training will not be provided beforehand. Sites will receive the necessary protocols and instructions for use required to implement the study protocol. Testing on the LIAISON PLEX® platform will be performed by trained operators. Study staff will receive training on the device prior to the start of testing. The diagnostic accuracy of the LIAISON® NES FLU A/B, RSV & COVID-19 assay will be evaluated using dry NS specimens prospectively collected from patients who meet the study inclusion criteria. The diagnostic accuracy of the LIAISON PLEX® RSP Flex assay will be evaluated using NS and NPS specimens prospectively collected from patients who meet the study inclusion criteria and stored in the applicable transport media. Performance of the LIAISON® NES FLU A/B, RSV & COVID-19 and LIAISON PLEX® RSP Flex assays will be compared to one or more US FDA-cleared molecular assays, or as required by the local regulatory body.

Approximately 600-1000 prospective specimens will be tested using the LIAISON® NES FLU A/B, RSV & COVID-19 and LIAISON PLEX® RSP Flex assays, with a goal to obtain approximately 50 comparator method confirmed positives per target for influenza A and SARS CoV-2 and 30 comparator method confirmed positives per target for influenza B and RSV. The study is estimated to be conducted for approximately 3 months and should cover the length of the flu season, as appropriate.

• 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

• LIAISON NES FLU A/B, RSV, & COVID-19
• LIAISON PLEX Respiratory Flex Assay

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Primary Purpose

Diagnostic

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

DiaSorin Molecular LLCINDUSTRY

emabon@maxwellmedical.com.au03 7036 2450