Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
T99-41 Sharon Snider: 301-827-6242
August 30, 1999
Consumers Inquiries: 888-INFO-FDA
The laboratory test, made by Binax, Inc., of Portland, Maine, provides results in 15 minutes. It is intended to be used in conjunction with review of a patient's symptoms to rule out other potential causes of pneumonia. Test results can enable doctors to make a probable diagnosis quicker and start treatment with the appropriate antibiotics sooner.
To perform the test, a swab is dipped into a urine specimen, removed and inserted into the test device. The test detects S. pneumoniae antigen in the urine of infected patients within 15 minutes. A positive result indicates that the patient most likely has pneumococcal pneumonia. Results should be confirmed with culture.
Conventional methods for diagnosing pneumonia, primarily using sputum or blood, are lengthy (requiring two to three days to several weeks for results), often complex and not always reliable. The new test is not only quicker, but is much easier to use.
FDA's clearance of the Binax test was based on results of clinical studies in hospitals and outpatient clinics conducted by the manufacturer at seven sites in the U.S. The studies included consideration of substances in urine that might interfere with test results and the effects of vaccination for pneumonia on test results.
The test was found to be 93 percent accurate in detecting S. pneumoniae when it was performed on urine samples from 373 patients known to have pneumococcal pneumonia. It was 78 percent accurate when performed on urine from 215 patients who had typical symptoms of pneumonia but may not have had the disease. Test results were not reliable in people who had been vaccinated for pneumonia within the past five days.