Curian S. Pneumo/Legionella Assay Beta Clinical Trial Protocol

Curian S. Pneumo/Legionella Assay Beta Clinical Trial Protocol

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.

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