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

DiaSorin

Status: Not yet enrolling

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

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06392451

DSM-PROT-005190

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,000 participants in 1 patient group

Blinded, Prospective Arm

Other group

Description:

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.

Treatment:

Diagnostic Test: LIAISON PLEX Respiratory Flex Assay

Diagnostic Test: LIAISON NES FLU A/B, RSV, & COVID-19