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
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The DiaSorin Molecular LIAISON® NES FLU A/B, RSV \& COVID-19 real-time polymerase chain reaction (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, RSV 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, 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.
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
AI-Powered 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
CONTACT
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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