Influenza ANCT06392451
LIAISON NES Influenza (FLU) A/B, Respiratory Syncytial Virus (RSV), & Coronavirus Disease 2019 (COVID-19) in Symptomatic Patients in Australia
A study testing LIAISON NES FLU A/B, RSV, & COVID-19 and LIAISON PLEX Respiratory Flex Assay in people with Influenza A and Influenza Type B, run by DiaSorin Molecular LLC at 4 sites in Australia.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Influenza A, Influenza Type B, Coronavirus Disease 2019
- What is being tested?
- LIAISON NES FLU A/B, RSV, & COVID-19 and LIAISON PLEX Respiratory Flex Assay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 4 sitesAustralia
- Study dates
- 6 May 2024to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
Australia4 sites
Key Health - Bondi
Bondi Junction, New South Wales, 2022
Ebony Hopping, 02 8262 1000, ebony.hopping@keyhealth.com.au
Rachel Behounek, PhD, 512-336-3554, rbehounek@luminexcorp.com
Maxwell Medical Group
Melbourne, Victoria, 3019
Euan Mabon, MD, 03 7036 2450, emabon@maxwellmedical.com.au
Rachel Behounek, PhD, 512-336-3554, rbehounek@luminexcorp.com
Key Health - CBD South
Sydney, New South Wales, 2000
Ebony Hopping, 02 8262 1000, ebony.hopping@keyhealth.com.au
Rachel Behounek, PhD, 512-336-3554, rbehounek@luminexcorp.com
Key Health - Pagewood
Sydney, New South Wales, 2036
Ebony Hopping, 02 8262 1000, ebony.hopping@keyhealth.com.au
Rachel Behounek, PhD, 512-336-3554, rbehounek@luminexcorp.com
About this study
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
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.
Read the 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.
- Conditions
- Influenza A, Influenza Type B, Coronavirus Disease 2019, Respiratory Syncytial Virus (RSV), Adenovirus, Enterovirus
- Being tested
- LIAISON NES FLU A/B, RSV, & COVID-19, LIAISON PLEX Respiratory Flex Assay
- Medical subject headings
- COVID-19, Adenoviridae Infections, Enterovirus Infections, Paramyxoviridae Infections, Whooping Cough, Psittacosis, Pneumonia, Mycoplasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIAISON NES FLU A/B, RSV, & COVID-19Diagnostic 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.
LIAISON PLEX Respiratory Flex AssayDiagnostic test
Also called VERIGENE II
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: LIAISON NES FLU A/B, RSV, & COVID-19; Diagnostic Test: LIAISON PLEX Respiratory Flex Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Samples will be tested on LIAISON NES within one hour of collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start6 May 2024 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DiaSorin Molecular LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janet Farhang, PhD, Principal investigator, DiaSorin Molecular/Luminex Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392451
- Sponsor's protocol ID
- DSM-PROT-005190
- Status last verified
- Apr 2024
- First submitted
- 26 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06392451
- Acronym / sponsor ID
- DSM-PROT-005190
- Conditions
- Influenza A, Influenza Type B, Coronavirus Disease 2019, Respiratory Syncytial Virus (RSV), Adenovirus, Enterovirus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- DiaSorin Molecular LLCIndustry (pharma, biotech, devices)
- Study start
- 6 May 2024 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blinded, Prospective Arm | Other | Diagnostic Test: LIAISON NES FLU A/B, RSV, & COVID-19, Diagnostic Test: LIAISON PLEX Respiratory Flex AssayClinical 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIAISON NES FLU A/B, RSV, & COVID-19The 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. | Diagnostic test | Blinded, Prospective Arm |
| LIAISON PLEX Respiratory Flex AssayAlso: VERIGENE IIThe 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. | Diagnostic test | Blinded, Prospective Arm |
Primary outcome
Diagnostic accuracy
Time frame: Samples will be tested on LIAISON NES within one hour of collection.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
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Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet Farhang, PhD principal investigator
DiaSorin Molecular/Luminex Corporation
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIAISON NES FLU A/B, RSV, & COVID-19 and LIAISON PLEX Respiratory Flex Assay in people with Influenza A and Influenza Type B, run by DiaSorin Molecular LLC at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel Behounek, PhD (512-336-3554, rbehounek@luminexcorp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (time frame: Samples will be tested on LIAISON NES within one hour of collection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.