A Multi-Site Clinical Evaluation of the LIAISON NES FLU A/B, RSV & COVID-19 Assay in Symptomatic Patients

Recruiting now · Not applicable

Conditions studied: Influenza a, Influenza B, RSV, COVID 19

In brief

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.

Key facts

Study ID

NCT06672692

Run by

DiaSorin Molecular LLC

People needed

1000

Starts

2024-09-30

Expected to finish

2025-05-01

Last updated by the study team

2024-11-04

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The specimen is a NPS or NS from a patient collected and preserved in 3 mL Universal Transport Media (UTM), BD Universal Viral Transport (UVT), or MicroTest M4RT transport media, or 1 mL Copan Eswab (Liquid Amies).
• The specimen is from a patient who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinic or resident of a long-term care facility.
• The specimen is from a human patient with active signs and symptoms of respiratory tract infection at time of collection
• Specimen stored at 2-8°C for up to 72 hours from collection. If there is a delay in testing, store specimen at ≤-70 °C.
• The total volume of the leftover specimen received is ≥1.5 mL, except for specimens collected in Liquid Amies which requires a total leftover volume of ≥0.5 mL
• The specimen was received in good condition (no leakage or drying of the specimen).

You may not qualify if…

• Incorrect swab type
• Incorrect transport media
• Incorrect specimen handling (e.g. specimens not stored at recommended temperature)
• The specimen has undergone more than two freeze/thaw cycles
• Specimens collected with calcium alginate or organic swabs

Where it is running

• PAS Research - Henderson — Henderson, Nevada, United States (enrolling)
• PAS Research - Pittsburgh — Pittsburgh, Pennsylvania, United States (enrolling)
• PAS Research - McAllen — McAllen, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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