Trials / Completed
CompletedNCT05681156
Curian S. Pneumo/Legionella Assay Beta Clinical Trial Protocol
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 199 (actual)
- Sponsor
- Meridian Bioscience, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Beta trial to evaluate the preliminary clinical performance of the Curian S. pneumo/Legionella assay for its use in the qualitative detection of Streptococcus pneumoniae and/or Legionella pneumophila serogroup 1 antigens in human urine specimens.
Detailed description
This study will evaluate the preliminary clinical performance of the RUO Curian S. pneumo/Legionella assay against two FDA cleared comparators for its use in the qualitative detection of Streptococcus pneumoniae and/or Legionella pneumophila serogroup 1 antigens in human urine specimens.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | N/A- There is no intervention. | There is no intervention. |
Timeline
- Start date
- 2023-02-01
- Primary completion
- 2023-03-23
- Completion
- 2023-09-08
- First posted
- 2023-01-12
- Last updated
- 2025-01-29
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05681156. Inclusion in this directory is not an endorsement.