FDA Clears 15-Minute Urine Test For Streptococcal Pneumonia
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FDA Clears 15-Minute Urine Test For Streptococcal Pneumonia

PORTLAND, ME -- November 11, 1999 -- Streptococcal pneumonia, the number one type of bacterial pneumonia in the US, strikes about a half million Americans each year and is most prevalent during the winter season. With the new FDA-cleared NOW(R) S. pneumoniae Urinary Antigen Test, the first and only self-contained urine test for streptococcal pneumonia, doctors can now accurately diagnose the disease in only 15 minutes and prescribe the right medication before the patient leaves the office.

Streptococcal pneumonia is a serious disease, caused by the Streptococcus pneumoniae (S. pneumoniae) bacteria, that often leads to hospitalization and can be deadly -- particularly for the very young and very old. Streptococcal pneumonia requires immediate and proper treatment with targeted antibiotics. Until now, however, doctors often prescribed antibiotics without testing for the disease or they had to wait more than a week for test results that were often inaccurate.

Without an accurate diagnostic tool for streptococcal pneumonia, it was very difficult to distinguish this disease from other types of pneumonia, particularly viral pneumonia -- two different diseases with similar symptoms. "Without having a definite diagnosis, doctors often hedged their bets by prescribing broad spectrum antibiotics to cover all conceivable pathogens despite the fact that S. pneumoniae is the most common cause of bacterial pneumonia," says pneumonia authority, Dr. Victor Yu, Professor of Medicine at the University of Pittsburgh. "Ironically, broad spectrum antibiotics often cover the other causes of pneumonia, but are not as potent against S. pneumoniae."

"With the availability of this rapid test, doctors can now know immediately, and with confidence, that the cause of the pneumonia is S. pneumoniae. Then, they can select the best antibiotics and prescribe them right away. Immediate treatment with targeted antibiotics means that patients get relief faster and they are less likely to develop complications," says Dr. Victor Yu. "Targeted antibiotics are also cheaper than the broad spectrum antibiotics."

"More importantly, the use of targeted antibiotics means that broad spectrum antibiotics can be avoided, and this can help curb the emergence of 'super bugs' -- bacteria that are resistant to a number of antibiotics. These 'super bugs' are now multiplying at an alarming rate worldwide, and this is becoming a major public health problem," says Dr. Yu. "Antibiotics are rapidly losing their effectiveness."

"The test is an important new diagnostic tool for pediatricians because pneumonia is a particularly dangerous disease for young children," says Dr. Kenneth Bromberg, Vice Chairman of Pediatrics at the SUNY Health Sciences Center/Brooklyn, Associate Professor of Pediatrics, Medicine, and Microbiology/Immunology. "The test is very useful because once streptococcal
pneumonia is diagnosed, we can begin treatment with targeted antibiotics and, if these antibiotics don't work, we can adjust the therapy appropriately because we know the pathogen with which we are dealing."

"Also, pediatricians are often faced with the dilemma of prescribing antibiotics needlessly," continues Dr. Bromberg. "Parents often demand antibiotics because they want to 'do something fast' to help their child feel better. Some also believe that once on antibiotics, it's okay to send their child back to school or daycare -- an important consideration for working parents. But, antibiotics do nothing to cure viral pneumonia, and may result in an increase of resistant bacteria that can reduce the child's ability to fight back with an antibiotic the next time a bacterial infection sets in. The child can also spread these resistant bacteria to other children and their families."

Anyone with severe chest pain, a cough that produces a green or rust-colored mucus, and a high fever and headache should see a doctor immediately. If the doctor says it is pneumonia, the test should be given immediately.

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