Actively Recruiting
A Multi-Site Clinical Evaluation of the LIAISON NES FLU A/B, RSV & COVID-19 Assay in Symptomatic Patients
Led by DiaSorin Molecular LLC · Updated on 2024-11-04
1000
Participants Needed
3
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the LIAISON NES FLU A/B, RSV & COVID-19 assay used on the LIAISON NES instrument for detecting and distinguishing influenza A, influenza B, RSV, and SARS-CoV-2 viruses in patients showing symptoms of respiratory tract infections. This test is designed to help in the differential diagnosis of these infections in a professional laboratory setting, but negative results alone should not guide patient management as they do not rule out infection. The study is interventional and involves multiple sites. The trial involves collecting clinical specimens, mainly nasal swabs, from symptomatic patients. These specimens are collected prospectively by healthcare professionals, with up to 40% possibly self-collected under supervision. Nasopharyngeal swabs may also be collected by professionals, especially in children 13 years or younger. The assay uses real-time polymerase chain reaction (RT-PCR) to detect viral RNA directly from dry nasal swabs without the need for nucleic acid extraction. Participants will provide nasal or nasopharyngeal swabs preserved in specific transport media, which are tested on the LIAISON NES instrument within one to two hours of collection. The study measures the diagnostic accuracy and clinical performance of the assay. Specimens are carefully stored and handled to maintain quality. The trial monitors conditions including influenza A, influenza B, RSV, and COVID-19 infections and is expected to complete by May 2025.
CONDITIONS
Brief Title
A Multi-Site Clinical Evaluation of the LIAISON NES FLU A/B, RSV & COVID-19 Assay in Symptomatic Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The specimen is a nasopharyngeal or nasal swab collected and preserved in approved transport media such as Universal Transport Media, BD Universal Viral Transport, MicroTest M4RT, or Copan Eswab.
- The specimen is from a patient who is hospitalized, in an emergency department, outpatient clinic, or residing in a long-term care facility.
- The patient has active signs and symptoms of respiratory tract infection at the time of specimen collection.
- Specimens are stored at 2-8°C for up to 72 hours or frozen at -70°C if testing is delayed.
- The leftover specimen volume is at least 1.5 mL, or at least 0.5 mL if collected in Liquid Amies.
- The specimen is received in good condition without leakage or drying.
You will not qualify if you...
- Specimens collected with incorrect swab types.
- Specimens transported in incorrect media.
- Specimens improperly handled or stored outside recommended temperatures.
- Specimens that have undergone more than two freeze/thaw cycles.
- Specimens collected using calcium alginate or organic swabs.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for specimen collection
Duration - Specimens are tested within 2 hours of collection
Participants provide nasal or nasopharyngeal swab specimens to be tested with the LIAISON NES FLU A/B, RSV & COVID-19 assay to evaluate respiratory infections.
1 visit (in-person) for specimen collection and testing
Trial Site Locations
Total: 3 locations
1
PAS Research - Henderson
Henderson, Nevada, United States, 89014
Actively Recruiting
2
PAS Research - Pittsburgh
Pittsburgh, Pennsylvania, United States, 15227
Actively Recruiting
3
PAS Research - McAllen
McAllen, Texas, United States, 78504
Actively Recruiting
Research Team
J
Janet Farhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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