TUESDAY, Nov. 19, 2002 (HealthDayNews) -- The U.S. Food and Drug Administration has approved a new test that can diagnose Group B Streptococcus in pregnant women in as little as one hour.
The IDI-Strep B test, made by Infectio Diagnostic Inc of Quebec, Canada, was shown to detect 94 percent of cases of Group B strep among 802 pregnant women who participated in company-sponsored clinical trials in the United States and Canada.
Its one-hour results contrast to those of the standard method of culture testing, which take 18 to 48 hours. A pregnant woman is typically screened for Group B strep two to four weeks before labor begins. If the results are positive, she is normally given four hours of antibiotic treatment during labor.
While this standard method has reduced the incidence of Group B strep by 70 percent during the past decade, it must be performed well in advance of when labor begins.
Group B strep is a major cause of serious illness and death among America's newborns when transmitted to the infant during birth. Some 10 percent to 30 percent of pregnant women are infected, the FDA says.
Here is the FDA Talk Paper describing the test. For more information about Group B strep, visit the U.S. Centers for Disease Control and Prevention.
