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Diagnostic Assay for Respiratory Infections (NES ABCR Trial)
N/A
Recruiting
Research Sponsored by DiaSorin Molecular LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Total volume of leftover specimen received is ≥1.5 mL, except for specimens collected in Liquid Amies which requires a total leftover volume of ≥0.5 mL
Specimen is from a patient who is hospitalized, admitted to a hospital emergency department, visiting an outpatient clinic, or resident of a long-term care facility
Timeline
Screening 3 weeks
Treatment Varies
Follow Up samples will be tested on liaison nes within one hour of collection.
Awards & highlights
No Placebo-Only Group
Summary
"This trial tests a new test called DiaSorin Molecular LIAISON NES FLU A/B, RSV & COVID-19, which is used to detect influenza A, influenza B, R
Who is the study for?
This trial is for patients showing symptoms of respiratory infections, who may have COVID-19, flu types A/B, or RSV. It's important that they are in the acute phase of their illness and haven't been diagnosed yet.
What is being tested?
The trial is testing the LIAISON NES FLU A/B, RSV & COVID-19 assay. This lab test uses a nasal swab to detect and differentiate between flu viruses A/B, RSV, and SARS-CoV-2 using RT-PCR technology.
What are the potential side effects?
As this is a diagnostic test rather than a treatment intervention, there are no direct side effects from the assay itself. However, discomfort or minor bleeding from the nasal swab procedure may occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My specimen volume is at least 1.5 mL, or 0.5 mL if in Liquid Amies.
Select...
I am currently hospitalized, visiting a clinic, or living in a long-term care facility.
Select...
I am showing signs of a respiratory infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ samples will be tested on liaison nes within one hour of collection.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~samples will be tested on liaison nes within one hour of collection.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Diagnostic Accuracy
Secondary study objectives
Clinical Performance
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Blinded, Prospective ArmExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
DiaSorin Molecular LLCLead Sponsor
2 Previous Clinical Trials
1,233 Total Patients Enrolled