Curian S. Pneumo/Legionella Assay Beta Clinical Trial Protocol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

199 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2023-09-08

Brief Summary

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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.

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Detailed Description

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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

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Streptococcus Pneumoniae Infection Legionella Pneumophila Serogroup 1 Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with suspected pneumonia

Leftover de-identified samples from standard of care will be taken from patients suspected of having pneumonia due to Streptococcus pneumoniae and/or Legionella pneumophila serogroup 1 infection.

N/A- There is no intervention.

Intervention Type OTHER

There is no intervention.

Interventions

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N/A- There is no intervention.

There is no intervention.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No