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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: janet.farhang@diasorin.com
• Phone: 5124015472

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.