Evaluation of a new test for detecting flu and COVID-19 in patients with respiratory symptoms

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

This study is testing a new nasal swab test to see if it can accurately tell the difference between flu, RSV, and COVID-19 in people who have respiratory symptoms.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1000 (estimated)
• Sex: All
• Sponsor: DiaSorin Molecular LLC (Industry-sponsored)
• Locations: 3 sites (Henderson, Nevada and 2 other locations)
• Trial ID: NCT06672692 on ClinicalTrials.gov

What this trial studies

This clinical evaluation focuses on the DiaSorin Molecular LIAISON® NES FLU A/B, RSV & COVID-19 assay, which is designed to detect and differentiate nucleic acids from influenza A, influenza B, RSV, and SARS-CoV-2 in symptomatic patients. The assay utilizes real-time polymerase chain reaction (RT-PCR) technology on samples collected from dry nasal swabs. It aims to assist healthcare professionals in the differential diagnosis of respiratory infections during the acute phase, taking into account clinical and epidemiological factors. The study will be conducted across multiple sites to ensure a diverse patient population.

Who should consider this trial

Good fit: Ideal candidates include patients with active respiratory symptoms who are hospitalized, visiting emergency departments, outpatient clinics, or residing in long-term care facilities.

Not a fit: Patients who do not exhibit active signs and symptoms of respiratory tract infection or those with incorrect specimen collection may not benefit from this study.

Why it matters

Potential benefit: If successful, this assay could improve the accuracy of diagnosing respiratory infections, leading to better patient management and treatment outcomes.

How similar studies have performed: Other studies utilizing RT-PCR assays for respiratory infections have shown promising results, indicating that this approach is supported by previous successes.

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

Where this trial is running

Henderson, Nevada and 2 other locations

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

Study contacts

• Study coordinator: Janet Farhang

Conditions Influenza a; Influenza B; RSV; COVID 19