FDA Talk Paper


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T02-45 Media Inquiries: 301-827-6242
November 18, 2002 Consumer Inquiries: 888-INFO-FDA


The Food and Drug Administration today cleared for marketing a new laboratory test for Group B Streptococcus in pregnant women.

The new test, the IDI-Strep B test, made by Infectio Diagnostic, Inc., of Quebec, can provide results in one hour, if facilities can provide round-the-clock testing. In contrast, the standard method of culture testing takes 18 to 48 hours for results. The new test is performed using a Cepheid Smart Cycler instrument on a swab sample taken from the vagina and rectum.

Group B strep is a leading cause of illness and death among newborns in the United States. It can be acquired during birth from mothers who unknowingly have the organism. An estimated 10 percent to 30 percent of pregnant women have Group B strep. However, antibiotic treatment of the mother during labor can prevent transmission to the newborn.

Pregnant women are typically screened for Group B strep two to four weeks before labor begins using the standard culture method, as recommended by the Centers for Disease Control and Prevention (CDC). If the test is positive for Group B strep, the woman is given four hours of antibiotic treatment during labor.

Use of this standard screening method has led to a 70 percent decline in the incidence of Group B strep during the past decade. However, because of the time needed to culture samples and the four hours needed for antibiotic treatment, it is only useful for women who are tested at least several days before labor begins--not those who start labor early, or who do not have the advantage of pre-natal care. The new IDI-Strep B test, with timely results, could be particularly beneficial for these women when they first go into labor.

FDA cleared the IDI Strep B test based on clinical studies conducted by the manufacturer of 802 women at five medical centers in the United States and Canada. The studies showed that the test detected approximately 94 percent of Group B strep in pregnant women.

The IDI-Strep B test is the first non-culture test that meets the performance criteria recommended by CDC guidelines--at least 85% sensitive compared to culture methods. Because of this, it can be used instead of standard culture methods.


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