What is the LIAISON NES FLU A/B, RSV & COVID-19 assay studying for respiratory infections?

The LIAISON NES FLU A/B, RSV & COVID-19 assay is being studied to detect and differentiate influenza A, influenza B, RSV, and SARS-CoV-2 viruses in patients with respiratory symptoms. This helps in making accurate diagnoses in a laboratory setting. The study is sponsored by DiaSorin Molecular LLC and aims to evaluate the test's diagnostic accuracy and clinical performance.

Who may be eligible for this respiratory infection clinical trial?

Adults and children showing active respiratory symptoms who are hospitalized, visiting emergency or outpatient clinics, or residing in long-term care facilities may be eligible. The specimen must be a nasal or nasopharyngeal swab collected and preserved properly. There is no gender restriction. Please review eligibility criteria for more details.

Is there any cost to participate in this respiratory infection clinical trial?

Study-related care, including the testing procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

All Genders

ID06672692

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

Led by DiaSorin Molecular LLC · Updated on 2024-11-04

1000

Participants Needed

Research Sites

8 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the LIAISON NES FLU AB, RSV COVID-19 assay used on the LIAISON NES instrument for detecting and distinguishing influenza A, influenza B, RSV, and SARS-CoV-2 viruses in patients showing symptoms of respiratory tract infections. This test is designed to help in the differential diagnosis of these infections in a professional laboratory setting, but negative results alone should not guide patient management as they do not rule out infection. The study is interventional and involves multiple sites. The trial involves collecting clinical specimens, mainly nasal swabs, from symptomatic patients. These specimens are collected prospectively by healthcare professionals, with up to 40 possibly self-collected under supervision. Nasopharyngeal swabs may also be collected by professionals, especially in children 13 years or younger. The assay uses real-time polymerase chain reaction RT-PCR to detect viral RNA directly from dry nasal swabs without the need for nucleic acid extraction. Participants will provide nasal or nasopharyngeal swabs preserved in specific transport media, which are tested on the LIAISON NES instrument within one to two hours of collection. The study measures the diagnostic accuracy and clinical performance of the assay. Specimens are carefully stored and handled to maintain quality. The trial monitors conditions including influenza A, influenza B, RSV, and COVID-19 infections and is expected to complete by May 2025.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

You may qualify if you...

The specimen is a nasopharyngeal or nasal swab collected and preserved in approved transport media such as Universal Transport Media, BD Universal Viral Transport, MicroTest M4RT, or Copan Eswab.
The specimen is from a patient who is hospitalized, in an emergency department, outpatient clinic, or residing in a long-term care facility.
The patient has active signs and symptoms of respiratory tract infection at the time of specimen collection.
Specimens are stored at 2-8°C for up to 72 hours or frozen at -70°C if testing is delayed.
The leftover specimen volume is at least 1.5 mL, or at least 0.5 mL if collected in Liquid Amies.
The specimen is received in good condition without leakage or drying.

You will not qualify if you...

Specimens collected with incorrect swab types.
Specimens transported in incorrect media.
Specimens improperly handled or stored outside recommended temperatures.
Specimens that have undergone more than two freeze/thaw cycles.
Specimens collected using calcium alginate or organic swabs.

Research Team

Janet Farhang

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