The results for a real-time PCR assay, using the LightCycler Strep B analyte-specific reagents (Roche Diagnostics Corporation, Indianapolis, Ind.), were compared to a direct plate method combined with a broth enrichment culture method for detection of group B streptococcus colonization in pregnant women. Two separate evaluations were conducted using two different automated nucleic extraction instruments, the Guidelines from the Centers for Disease Control and Prevention recommend screening for vaginal or rectal carriage of group B streptococcus (GBS) (Streptococcus agalactiae) by culture in pregnant women at 35 to 37 weeks gestation (3). Both the vaginal and anal areas should be swabbed, and the culture method should include an enrichment broth. These recommendations are based on prior studies which have demonstrated that intrapartum surveillance for GBS and treatment of carriers significantly decreases early-onset (within 1 week after birth) GBS meningitis and sepsis in the newborn (2, 6, 7).Recently, real-time PCR methods have been applied for direct detection of GBS from vaginal/rectal swabs (1, 5). These methods have been demonstrated to be as sensitive as culture but have the added advantage of being much faster. Because of their speed, real-time PCR tests have the potential for screening at the time of delivery. This could decrease the overutilization of antibiotics, especially in pregnant women who do not have prepartum screening for GBS.The objective of the current study was to evaluate the ability of the LightCycler Strep B ptsI assay (Roche Diagnostics Corporation) to detect GBS carriage in pregnant women. This real-time PCR assay uses dual fluorescent resonance energy transfer (FRET) probes, also referred to as FRET hybridization probes. We compared the performance of this LightCycler assay to the results for a direct plate culture method combined with the results for a broth enrichment culture recommended by the Centers for Disease Control and Prevention. In addition, we evaluated two DNA extraction protocols, one using the MagNA Pure LC instrument (Roche Diagnostics Corporation) and the other using the lower-capacity MagNA Pure Compact instrument (Roche Diagnostics Corporation). MATERIALS AND METHODSStudy design. The study was approved by the Institutional Review Board of the Mayo Foundation. Two separate evaluations were conducted using the LightCycler Strep B assay, with either the MagNA Pure LC instrument or the MagNA Pure Compact instrument. For each of these evaluations, a different set of vaginal/rectal swabs were collected from pregnant women.For the MagNA Pure LC/LightCycler Strep B protocol, specimens were collected in June and July 2003. Eighteen specimens (10.3%) were excluded from the study because the patients from whom these swabs were collected declined to provide permission to use their specimens and medical histories for evaluation (Minnesota Statute 144.335). One hundred fifty-nine swabs from 154 patients were available for testing.For the MagNA Pure Compact/LightCycler Strep B pro...

This theory may help explain the fetal stillbirths in women taking this class of medications during the second and third trimester of pregnancy.

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