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NCT06672692 · ClinicalTrials.gov registry record · NA
A Multi-Site Clinical Evaluation of the LIAISON NES FLU A/B, RSV & COVID-19 Assay in Symptomatic Patients
A NA study of COVID-19 and Influenza a, sponsored by DiaSorin Molecular.
- Recruiting
- Registry status
- NA
- Development phase
- 1,000
- Enrollment target
- 3
- Study locations
NCT06672692: Recruiting NA study of COVID-19 and Influenza a, sponsored by DiaSorin Molecular.
NCT06672692 is a NA study of COVID-19 and Influenza a that is actively recruiting participants, run by DiaSorin Molecular. The registered enrollment target is 1,000 participants, below the 38,462-participant average among 298 other COVID-19 trials with a reported enrollment target (97% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06672692, a NA study of COVID-19 and Influenza a, is actively recruiting participants, sponsored by DiaSorin Molecular.
- RECRUITING
- Registry status
- NA
- Development phase
- 1,000 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
Estimates of Sensitivity/percent positive agreement (PPA) and Specificity/percent negative agreement (NPA) will be calculated based on a two-by-two table (comparator method result vs. result from LIAISON® NES FLU A/B, RSV \& COVID-19 assay or LIAISON PLEX® RSP Flex assay) for each target. In addition, 95% two-sided confidence intervals will be provided. A separate Sensitivity/PPA and Specificity/NPA for each target, to include those specimens excluded due to a discrepancy between the standard-of
Conditions Studied
Interventions
- DIAGNOSTIC_TEST LIAISON NES FLU A/B, RSV & COVID-19
Study Locations (3)
Nevada
- PAS Research - Henderson - Henderson
Pennsylvania
- PAS Research - Pittsburgh - Pittsburgh
Texas
- PAS Research - McAllen - McAllen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2024-09-30 |
| Est. Completion | 2025-05 |
| Phase | NA |
What NCT06672692 shows while recruiting
NCT06672692 is an interventional study that assigns participants to a tested intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, below the 38,462-participant average among 298 other COVID-19 trials with a reported enrollment target (97% lower).
The record links to 4 conditions, with COVID-19 appearing as the primary indexed condition, and to 1 intervention - of which LIAISON NES FLU A/B, RSV & COVID-19 is the first listed.
NCT06672692 reports a single indexed study location in Nevada, Pennsylvania, Texas.
Frequently Asked Questions
What is clinical trial NCT06672692 about?
NCT06672692 is a clinical study titled "A Multi-Site Clinical Evaluation of the LIAISON NES FLU A/B, RSV & COVID-19 Assay in Symptomatic Patients". 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 vir...
What is the current status of trial NCT06672692?
This trial is currently recruiting. It is a NA study. The enrollment target is 1,000 participants. The study started on 2024-09-30. Estimated completion is 2025-05.
What conditions does trial NCT06672692 study?
This clinical trial studies the following conditions: COVID-19, Influenza a, Influenza B, RSV.
What interventions are being tested in trial NCT06672692?
The interventions under investigation include: LIAISON NES FLU A/B, RSV & COVID-19 (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06672692?
This trial is sponsored by DiaSorin Molecular, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06672692 being conducted?
This trial has 3 study locations across Nevada, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06672692's enrollment target sits among peer trials
1,000 71st of 298 higher than 222 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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