Streptococcus IVDs

Intended purpose

Sofia S. pneumoniae FIA employs immunofluorescence for qualitative detection of Streptococcus pneumoniae antigen in urine specimens of patients with pneumonia and in cerebral spinal fluid (CSF) specimens of patients with meningitis. Test results are to be used as an aid in diagnosis of both pneumococcal pneumonia and pneumococcal meningitis. A negative result does not preclude infections with Streptococcus pneumoniae. Test results are to be used in conjunction with information obtained from the patient’s clinical evaluation and other diagnostic procedures. This test is intended for professional point of care and laboratory use.