Clinical trial NCT06392451: LIAISON NES Influenza (FLU) A/B, Respiratory Syncytial Virus (RSV), & Coronavirus Disease 2019 (COVID-19) in Symptomatic Patients in Australia
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: DiaSorin Molecular LLC
Sponsor class: INDUSTRY
First posted: 2024-04-30
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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 outcomes:
measure: Diagnostic accuracy
timeFrame: Samples will be tested on LIAISON NES within one hour of collection.
Secondary outcomes:
Other outcomes:
Locations:
city: Bondi Junction
country: Australia
facility: Key Health - Bondi
state: New South Wales
city: Sydney
country: Australia
facility: Key Health - CBD South
state: New South Wales
city: Sydney
country: Australia
facility: Key Health - Pagewood
state: New South Wales
city: Melbourne
country: Australia
facility: Maxwell Medical Group
state: Victoria
Study officials:
affiliation: DiaSorin Molecular/Luminex Corporation
name: Janet Farhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: