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Urine test to detect pneumonia bacteria OK'd
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9-13-99 Rockville, Md. The Food and Drug Administration has approved a simple 15-minute urine test for detecting Streptococcus pneumoniae, a leading cause of pneumonia. Manufactured by Binax Inc. in Portland, Maine, the test is performed by dipping a swab into a room-temperature urine specimen, then inserting the specimen into the testing device. The test detects the presence of S. pneumoniae antigen in the urine within 15 minutes. The FDA is advising physicians to confirm the results of the new test with conventional laboratory tests. Binax tested 373 patients known to have pneumonia caused by strep, and the urine test was 93 percent accurate, the FDA said. In 213 patients with pneumonia symptoms not necessarily caused by strep, the test was 78 percent accurate. The test was not reliable on people vaccinated for pneumonia within five days prior to testing. "Though this has not yet been used outside of study settings, it is everybody's hope that this is a rapid and reliable test for this pneumonia," said James Summersgill, PhD, associate professor of medicine and director of infectious disease laboratories at the University of Louisville, which was one of the sites for the study. "It is a very rapid test, and very easy to read." The test costs about $30, according to Binax. Symptoms alone do not always help healthcare providers identify whether a case of pneumonia is caused by a virus or bacteria, and it can take more than a week to find out with conventional tests. Consequently, physicians often prescribe antibiotics to be safe, even though they have no effect if the pneumonia is caused by a virus. Unnecessary exposure to antibiotics can lead other bacteria in the body to develop resistance to the drugs.
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