A Multi-Site Clinical Evaluation of the LIAISON NES FLU A/B, RSV & COVID-19 Assay in Symptomatic Patients
NCT ID: NCT06672692
Last Updated: 2024-11-04
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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RECRUITING
NA
1000 participants
INTERVENTIONAL
2024-09-30
2025-05-31
Brief Summary
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The LIAISONĀ® NES FLU A/B, RSV \& COVID-19 assay is intended for use as an aid in the differential diagnosis of influenza A, influenza B, RSV and SARS-CoV-2 infection in a professional laboratory setting.
Negative results do not preclude influenza A, influenza B, RSV 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, RSV & COVID-19
The LIAISONĀ® NES FLU A/B, RSV \& COVID-19 assay used on the LIAISONĀ® 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 RSV 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, RSV & COVID-19
The LIAISONĀ® NES FLU A/B, RSV \& COVID-19 assay used on the LIAISONĀ® 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 RSV 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
* The specimen is from a patient who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinic or resident of a long-term care facility.
* The specimen is from a human patient with active signs and symptoms of respiratory tract infection at time of collection
* Specimen stored at 2-8Ā°C for up to 72 hours from collection. If there is a delay in testing, store specimen at ā¤-70 Ā°C.
* The total volume of the leftover specimen received is ā„1.5 mL, except for specimens collected in Liquid Amies which requires a total leftover volume of ā„0.5 mL
* The specimen was received in good condition (no leakage or drying of the specimen).
Exclusion Criteria
* Incorrect transport media
* Incorrect specimen handling (e.g. specimens not stored at recommended temperature)
* The specimen has undergone more than two freeze/thaw cycles
* Specimens collected with calcium alginate or organic swabs
ALL
No
Sponsors
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DiaSorin Molecular LLC
INDUSTRY
Responsible Party
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Locations
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PAS Research - Henderson
Henderson, Nevada, United States
PAS Research - Pittsburgh
Pittsburgh, Pennsylvania, United States
PAS Research - McAllen
McAllen, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DSM-PROT-005198
Identifier Type: -
Identifier Source: org_study_id
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