LIAISON NES Influenza (FLU) A/B & Coronavirus Disease 2019 (COVID-19) Clinical Agreement in Australia
NCT ID: NCT05897515
Last Updated: 2024-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
233 participants
INTERVENTIONAL
2023-06-19
2023-10-31
Brief Summary
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The LIAISON® NES FLU A/B \& COVID-19 assay is intended for use as an aid in the differential diagnosis of influenza A, influenza B and SARS-CoV-2 infection in a professional laboratory setting.
Negative results do not preclude influenza A, influenza B, or SARS-CoV-2, infection and should not be used as the sole basis for patient management decisions. The assay is not intended to detect the presence of the influenza C virus.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Blinded, Prospective Arm
Clinical specimens shall be collected prospectively from patients with signs or symptoms of respiratory tract infection. Nasal swab 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 nasal swab 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.
LIAISON NES FLU A/B & COVID-19
The LIAISON® NES FLU A/B \& COVID-19 assay used on the LIAISON® NES instrument is a real-time PCR system that enables the direct amplification, detection and differentiation of Flu A viral RNA, Flu B viral RNA and SARS-CoV-2 RNA from dry nasal swabs. Nasal Swabs can be professionally collected by a Healthcare Provider or self-collected by the patient under the supervision of the healthcare provider. The collected nasal swab can then be directly loaded into the cartridge without nucleic acid extraction.
Interventions
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LIAISON NES FLU A/B & COVID-19
The LIAISON® NES FLU A/B \& COVID-19 assay used on the LIAISON® NES instrument is a real-time PCR system that enables the direct amplification, detection and differentiation of Flu A viral RNA, Flu B viral RNA and SARS-CoV-2 RNA from dry nasal swabs. Nasal Swabs can be professionally collected by a Healthcare Provider or self-collected by the patient under the supervision of the healthcare provider. The collected nasal swab can then be directly loaded into the cartridge without nucleic acid extraction.
Eligibility Criteria
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Inclusion Criteria
* Specimens collected within 7 days of symptom onset for the initial collection
* 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 transport media
* Incorrect specimen handling (specimens not stored at recommended temperature)
* Samples collected \>7 days from symptom onset
* Subjects not consented
ALL
No
Sponsors
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DiaSorin Molecular LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janet Farhang, PhD
Role: PRINCIPAL_INVESTIGATOR
DiaSorin Molecular/Luminex Corporation
Locations
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Grampians Health
Ballarat, Victoria, Australia
Countries
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Other Identifiers
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DSM-PROT-005131
Identifier Type: -
Identifier Source: org_study_id
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