NCT06672692 A Multi-Site Clinical Evaluation of the LIAISON NES FLU A/B, RSV & COVID-19 Assay in Symptomatic Patients
| NCT ID | NCT06672692 |
| Status | Recruiting |
| Phase | — |
| Sponsor | DiaSorin Molecular LLC |
| Condition | Influenza a |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-09-30 |
| Primary Completion | 2025-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2024-09-30 with a primary completion date of 2025-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06672692 clinical trial?
This trial is open to participants of all sexes, studying Influenza a. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06672692 currently recruiting?
Yes, NCT06672692 is actively recruiting participants. Contact the research team at janet.farhang@diasorin.com for enrollment information.
Where is the NCT06672692 trial being conducted?
This trial is being conducted at Henderson, United States, Pittsburgh, United States, McAllen, United States.
Who is sponsoring the NCT06672692 clinical trial?
NCT06672692 is sponsored by DiaSorin Molecular LLC. The trial plans to enroll 1,000 participants.