UnknownNot Applicable

LIAISON NES Influenza (FLU) A/B, Respiratory Syncytial Virus (RSV), & Coronavirus Disease 2019 (COVID-19) in Symptomatic Patients in Australia

Australia1,000 participantsStarted 2024-05-06

Plain-language summary

To establish the relative accuracy of the LIAISON® NES Flu A/B, RSV \& COVID-19 assay for viral nucleic acid targets from professionally collected or patient self-collected dry nasal (NS) swabs and to establish the relative accuracy of the LIAISON PLEX® RSP Flex assay from NS and nasopharyngeal swabs (NPS) in applicable transport media from human patients exhibiting clinical signs and symptoms of a respiratory tract infection.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Human patients with active signs and symptoms of respiratory tract infection at time of collection * Specimens collected within 7 days of symptom onset for the initial collection * Patient consents to participate in the study * Availability of age, gender, race, ethnicity, collection dates, collection time, routine respiratory testing method, routine respiratory result, signs and symptoms (e.g., fever), date of symptom onset for each symptom, vaccination status (Flu and COVID-19, as applicable), pre-existing medical conditions (as applicable), medications (e.g., COVID-19 antivirals), etc. for each subject Exclusion Criteria: * Incorrect swab type * Incorrect transport media * Incorrect specimen handling (specimens not stored at recommended temperature) * Samples collected \>7 days from symptom onset * Subject does not provide informed consent or subject withdraws informed consent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Diagnostic accuracy

Timeframe: Samples will be tested on LIAISON NES within one hour of collection.

Trial details

NCT IDNCT06392451

SponsorDiaSorin Molecular LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-31

Contact for this trial

Rachel Behounek, PhD

512-336-3554 rbehounek@luminexcorp.com

View on ClinicalTrials.gov More Influenza A trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.