Curian S. Pneumo/Legionella Assay Beta Clinical Trial Protocol

Meridian Bioscience

Status: Completed

Conditions: Streptococcus Pneumoniae Infection; Legionella Pneumophila Serogroup 1 Infection

Treatments: Other: N/A- There is no intervention.

Study type: Observational

Funder types: Industry

Identifiers

NCT05681156

CLIN0015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 199 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

199 participants in 1 patient group

Patients with suspected pneumonia

Description:

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.

Treatment:

Other: N/A- There is no intervention.