Group B strep antigen tests inadequate for maternity/infant diagnosis -- FDA safety alert.
This article was originally published in The Gray Sheet
Executive Summary
GROUP B STREP ANTIGEN TEST COMPARISON TO BROTH CULTURE TEST IN CLINICAL TRIALS will be discussed at an upcoming meeting between FDA and manufacturers. The agency says that the meeting will address clinical parameters of comparison trials between the antigen tests and broth culture, the gold standard for detection of Group B streptococcal infection. Due to public health concerns about the sensitivity of the antigen tests, the agency is conditioning continued market availability of the tests on the comparison trial.