Clinical and Interpretive

This assay is used in the rapid diagnosis of pneumococcal pneumonia. Streptococcus pneumoniae is the most frequently encountered bacterial agent of community-acquired pneumonia (CAP). Because of the significant morbidity and mortality associated with pneumococcal pneumonia, septicemia, and meningitis, it is important to have diagnostic test methods available that can provide a rapid diagnosis. In instances where empirical antibiotics are provided for CAP without culture confirmation of Streptococcus pneumoniae, antigen testing may be useful.

Pneumococcal pneumonia is best diagnosed by sputum culture. A negative result does not exclude Streptococcus pneumoniae infection. A diagnosis of Streptococcus pneumoniae infection must take into consideration all test results, culture results, and the clinical presentation of the patient.

Streptococcus pneumoniae vaccine may cause false-positive results, especially in patients who have received the vaccine within 5 days of having the test performed. This assay has not been validated for use with body fluids other than urine or cerebrospinal fluid. The performance of this assay in patients who have received antibiotics for >24 hours has not been established. The accuracy of this assay has not been proven in small children.