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October 22, 1997

Detection of Group B Streptococcal Infection-Reply

Author Affiliations

Food and Drug Administration Rockville, Md

JAMA. 1997;278(16):1317. doi:10.1001/jama.1997.03550160037024

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In Reply.  —Dr Jelsema is correct in stating that 2 strategies are presented by the CDC for the prevention of early onset GBS disease, one that includes culturing for the organism, and the other that addresses treatment based on maternal risk. However, as indicated by its title, the FDA article dealt only with matters regarding the detection of the GBS organism, either by an antigen test or by culturing the organism. The agency's goal with this FDA Safety Alert was to educate those who may use the GBS antigen tests to the limitations of the tests. The alert was not written as a general discussion on the prevention of early onset GBS disease.