Quickness, Ease Are Pluses With New Pneumonia Test

FDA Consumer, Nov, 1999

A new urine test that can detect the pneumonia-causing bacterium Streptococcus pneumoniae in 15 minutes has been approved by FDA.

Approved in August, the Binax test can help doctors diagnose pneumonia more quickly than in the past and begin antibiotic treatment sooner.

The test is done by dipping a swab into a urine specimen and inserting it into the test device. A positive result indicates that the patient most likely has pneumococcal pneumonia, but the health professional should also review a patient's symptoms to rule out other possible causes of pneumonia.

According to FDA, the Binax test is much easier to use than conventional methods for diagnosing pneumonia, which primarily use saliva and mucus or blood, and can be lengthy, complex, and sometimes unreliable.

In studies conducted by the manufacturer, Binax Inc., Portland, Maine, the test was found to be 93 percent accurate in detecting S. pneumoniae when testing urine samples from 373 patients known to have pneumococcal pneumonia, and 78 percent accurate when testing urine from 215 patients with typical symptoms of pneumonia who may not have had the disease. Test results were not reliable in people who had been vaccinated for pneumonia within the previous five days.