The IDI-Strep B test uses the Cepheid SmartCycler instrument to analyze swab samples from the vagina and rectum for the detection of Group B Streptococcus in pregnant women. Unlike a standard culture method to grow the Group B Strep bacteria, the Smart Cycler instrument detects the DNA of Group B Strep and can provide results in 1 hour.
     The IDI-Strep B test is an FDA-cleared non-culture test that meets the performance criteria recommended by the Centers for Disease Control and Prevention (CDC) guidelines – at least 85% sensitive compared to culture methods. The test has demonstrated 94% sensitivity and 96% specificity.
     A woman may be tested at 35-37 weeks gestation, or at onset of labor provided results are available in sufficient time to allow four hours of antibiotic treatment prior to delivery to prevent transmission of Group B Strep to a newborn.
Cepheid
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Keywords: molecular diagnostics, infectious disease, perinatal care