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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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Indiana University
Indianapolis, Indiana, United States
Start Date
February 1, 2023
Primary Completion Date
March 23, 2023
Completion Date
September 8, 2023
Last Updated
January 29, 2025
199
ACTUAL participants
N/A- There is no intervention.
OTHER
Lead Sponsor
Meridian Bioscience, Inc.
NCT05759520
NCT03696303
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04944719