Curian S. Pneumo/Legionella Assay Beta Clinical Trial Protocol

Meridian Bioscience, Inc.199 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

199

Conditions

Streptococcus Pneumoniae Infection Legionella Pneumophila Serogroup 1 Infection

Interventions

N/A- There is no intervention.OTHER

There is no intervention.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult males and females, with symptom of pneumonia and for whom a Streptococcus pneumoniae and/or Legionella pneumophila serogroup 1 diagnostic test has been ordered by a practicing physician. * At least 2mL of urine from fresh de-identified clinical specimen from standard of care lab testing * Only one (1) specimen per patient will be included in the study * Materials used within their expiration date * Storage time and conditions within requested indications listed on RUO Package Insert Exclusion Criteria: * Specimens from patients for whom a Streptococcus pneumoniae and/or Legionella pneumophila serogroup 1 diagnostic test has not been ordered * Storage times and conditions that exceed these study protocol requirements listed on RUO Package Insert * Urine samples provided in unsatisfactory conditions

Locations (1)

Indiana University

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Agreement between Curian S. pneumo/Legionella Assay and two cleared FDA assays

Curian S. pneumo/Legionella Assay will be compared to the comparator assays (both FDA cleared)

Time frame: 7 months

Data from ClinicalTrials.gov

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