Clinical trial NCT06672692: A Multi-Site Clinical Evaluation of the LIAISON NES FLU A/B, RSV & COVID-19 Assay in Symptomatic Patients
Official title: A Multi-Site Clinical Evaluation of the LIAISON NES FLU A/B, RSV & COVID-19 Assay in Symptomatic Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Influenza a
Influenza B
RSV
COVID 19
Lead sponsor: DiaSorin Molecular LLC
Sponsor class: INDUSTRY
First posted: 2024-11-04
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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

Primary outcomes:
measure: Diagnostic Accuracy
timeFrame: Samples will be tested on LIAISON NES within two hours of collection.
Secondary outcomes:
measure: Clinical Performance
timeFrame: Samples will be tested on LIAISON NES within one hour of collection.
Other outcomes:
Locations:
city: Henderson
country: United States
facility: PAS Research - Henderson
state: Nevada
city: Pittsburgh
country: United States
facility: PAS Research - Pittsburgh
state: Pennsylvania
city: McAllen
country: United States
facility: PAS Research - McAllen
state: Texas
Study officials:
References: