FDA clears childbirth infection test
Group B Streptococcus
December 29, 2002
2002 DEC 29 - (NewsRx.com & NewsRx.net) -- Hospitals will soon be able to offer women in premature labor or who missed prenatal care a crucial test that may help protect hundreds of babies from a potentially deadly childbirth infection. The threat is group B streptococcus, a bacterium that lurks harmlessly in many women's bodies but that can be fatal or brain-damaging if passed to infants inside the birth canal.
Obstetricians already test women for group B strep 2-4 weeks before their due date, so that those infected can be given powerful
antibiotics during labor that protect many, although not all, of their newborns.
That test needs up to 48 hours for results and does not work once women are in labor, which means premature babies or those whose mothers lacked prenatal care remain at risk. November 18, 2002, the U.S. Food and Drug Administration approved the IDI-Strep B test, which can detect the infection once labor has begun and provides results in just 1 hour. That's often enough time to start antibiotics.
"It won't wipe it out, but it's certainly going to substantially help," said Dr. Steven Gutman, FDA's chief of clinical tests. Manufacturer Infectio Diagnostic, Inc., of Quebec also recently received approval from Canada's medical regulators and plans to begin selling the strep test in both countries early next year. It has not yet set a price. Up to 30% of American women harbor group B strep, a cousin of the bug that causes strep throat. It usually causes them no symptoms, but it can be deadly to their babies, causing bloodstream infections, pneumonia or meningitis.
In 1996, the U.S. Centers for Disease Control and Prevention recommended that pregnant women undergo routine screening for Group B strep during their third trimester. Those tests have cut infant infections by 70%.
Some 1600 babies still become seriously ill in the United States every year, and 80 die, the CDC said. Some survivors suffer long-term damage, from seizures to mental retardation.
The 1-hour test requires a vaginal swab. In a study of 802 women who
went into labor without routine screening, the test proved 94%
effective. That's slightly better than other tests, said FDA medical
reviewer Roxanne Shively. Because no one knew at the time of that study if the IDI-Strep B test worked, results weren't used during the women's labor. Had they been, 10% would have received different care – women who either got unnecessary antibiotics because they were wrongly suspected at risk despite no testing, or those who needed treatment but didn't get it, said Infectio spokesman Christian Choquet.
There is a caveat: The test requires several complicated steps to read, so 1-hour results will come only from health facilities that operate round-the-clock laboratories, the FDA cautioned. This article was prepared by Medical Letter on the CDC & FDA editors from staff and other reports.
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