LIAISON NES Flu A/B & COVID-19 Clinical Agreement

Study Overview
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Brief Summary
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The DiaSorin Molecular LIAISON® NES FLU A/B & COVID-19 real-time RT-PCR assay is intended for use on the DiaSorin LIAISON® NES instrument for the in-vitro qualitative detection and differentiation of nucleic acid from influenza A, influenza B and SARS-CoV-2 virus from dry nasal swabs (NS) from human patients with signs and symptoms during the acute phase of respiratory tract infection in conjunction with clinical and epidemiological risk factors. 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.

Official Title
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LIAISON NES Flu A/B & COVID-19 Clinical Agreement in Australia

Conditions
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Influenza A, Influenza Type B, Coronavirus Disease 2019

Intervention / Treatment
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* Diagnostic Test: LIAISON NES FLU A/B & COVID-19


Participation Criteria
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Eligibility Criteria
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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 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 Subjects not consented
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Blinded, Prospective Arm<br>Clinical specimens shall be collected prospectively from patients with signs or symptoms of respiratory tract infection. Nasal swab in Copan UTM 3mL 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 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 CDC guidelines for collecting nasopharyngeal swabs, unless otherwise specified by DiaSorin. | Diagnostic Test: LIAISON NES FLU A/B & COVID-19<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy | LIAISON NES will be compared to results obtained from a similar FDA-cleared device on the market. | Samples will be tested on LIAISON NES within one hour of collection. |