Actively Recruiting
Evaluation of the LIAISON NES FLU A/B, RSV & COVID-19 Assay in Symptomatic Patients with Respiratory Infections
Led by DiaSorin Molecular LLC · Updated on 2024-11-04
1000
Participants Needed
3
Research Sites
30 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, a real-time polymerase chain reaction (RT-PCR) test designed to detect and differentiate influenza A, influenza B, RSV, and SARS-CoV-2 viruses. This test uses dry nasal swabs collected from patients showing signs and symptoms of acute respiratory tract infection. It is intended to assist in diagnosing these viral infections in a professional laboratory setting but does not detect influenza C virus, and negative results should not be the sole basis for patient treatment decisions. The LIAISON NES assay works on the LIAISON NES instrument and allows direct amplification and detection of viral RNA from nasal swabs without needing nucleic acid extraction. Nasal swabs can be collected by healthcare providers or self-collected under supervision. The swabs are then loaded directly into cartridges for testing. Specimens must be collected and stored under specific conditions to ensure test accuracy. Participants provide nasal swab samples that are tested within two hours of collection on the LIAISON NES instrument to measure diagnostic accuracy. Samples must be stored properly and meet volume and condition requirements. The study includes patients from various healthcare settings, including hospitals, emergency departments, outpatient clinics, and long-term care facilities, who have active respiratory symptoms. This evaluation helps determine the assay's ability to detect these viral infections accurately.
CONDITIONS
Official 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 nasal or nasopharyngeal swab collected and preserved in approved transport media such as Universal Transport Media, BD Universal Viral Transport, MicroTest M4RT, or Copan Eswab (Liquid Amies).
- The specimen is from a patient who is hospitalized, admitted to an emergency department, visiting an outpatient clinic, or a resident of a long-term care facility.
- The specimen is from a human patient showing active signs and symptoms of respiratory tract infection at the time of collection.
- Specimens must be stored at 2-8 degrees Celsius for up to 72 hours from collection; if testing is delayed, store at or below -70 degrees Celsius.
- The leftover specimen volume must be at least 1.5 mL, except for specimens in Liquid Amies which require at least 0.5 mL.
- Specimen must be received in good condition without leakage or drying.
You will not qualify if you...
- Use of incorrect swab type.
- Use of incorrect transport media.
- Improper specimen handling, such as storage at incorrect temperatures.
- Specimen has undergone more than two freeze/thaw cycles.
- Specimens collected with calcium alginate or organic swabs.
AI-Screening
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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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