Evaluation of Universal Antenatal Screening for Group B Streptococcus

Dyke, Melissa K. Van; Phares, Christina R.; Lynfield, Ruth; Thomas, Ann; Arnold, Kathryn E.; Craig, Allen S.; Mohle-Boetani, Janet C.; Gershman, Ken; Schaffner, William; Petit, Susan; Zansky, Shelley; Morin, Craig; Spina, Nancy; Wymore, Kathryn; Harrison, Lee H.; Shutt, Kathleen A.; Bareta, Joseph; Bulens, Sandra N.; Zell, Elizabeth R.; Schuchat, Anne; Schrag, Stephanie J.

doi:10.1056/nejmoa0806820

Cited by 352 publications

(290 citation statements)

References 24 publications

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“…A recent meta-analysis also reported a lower prevalence of rectovaginal GBS colonization in Southeast Asia (11.1%), although the prevalence varied widely in India (2% to 16%) (15)(16)(17)(18)(19). However, this rate of maternal carriage was lower than those in sub-Saharan Africa (21% to 22%) (15,20,21), North America and South America (19.7% to 24%) (15,22), and Europe (19%) (15).…”

Section: Discussionmentioning

confidence: 96%

Group B Streptococcus among Pregnant Women and Newborns in Mirzapur, Bangladesh: Colonization, Vertical Transmission, and Serotype Distribution

et al. 2017

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Group B streptococcus (GBS) infection is a leading cause of death among newborns in developed countries. Data on the burden of GBS in Asian countries are lacking. This study aimed to understand (i) the rate of maternal rectovaginal GBS carriage, (ii) the rate of vertical transmission of GBS, as determined by culturing ear, umbilicus, and nasal swabs, and (iii) the distribution of GBS serotypes. This prospective observational study was conducted between September 2012 and November 2013 at Kumudini Women's Medical College Hospital, a secondary-level hospital in Mirzapur, Bangladesh. The study enrolled pregnant women who visited the outpatient clinic for antenatal care (ANC) and/or delivered a child in the inpatient department of Kumudini Women's Medical College Hospital and the babies born to those mothers. 12% [20/172 isolates]). This study shows that Bangladesh has all of the ingredients for invasive GBS disease, including colonization of mothers by invasive serotypes and vertical transmission to babies.

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Section: Discussionmentioning

confidence: 96%

Group B Streptococcus among Pregnant Women and Newborns in Mirzapur, Bangladesh: Colonization, Vertical Transmission, and Serotype Distribution

et al. 2017

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“…This extends the turnaround time (TAT) for results to 48 to 72 h. Because screening cultures are collected at 35 to 37 weeks' gestation, this delay does not typically impact patient man-agement. However, up to 15% of pregnant women do not receive adequate prenatal care including routine screening for GBS (10,11). In these cases, a more rapid and sensitive direct testing method for screening may be desirable.…”

Section: S Treptococcus Agalactiae (Group B Streptococcus [Gbs]) Is Amentioning

confidence: 99%

Multicenter Clinical Evaluation of the Xpert GBS LB Assay for Detection of Group B Streptococcus in Prenatal Screening Specimens

et al. 2015

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dNeonatal infection with Streptococcus agalactiae (group B Streptococcus [GBS]) is a leading cause of sepsis and meningitis in newborns. Recent guidelines have recommended universal screening of all pregnant women to identify those colonized with GBS and administration of peripartum prophylaxis to those identified as carriers to reduce the risk of early-onset GBS disease in neonates. Enriched culture methods are the current standard for prenatal GBS screening; however, the implementation of more sensitive molecular diagnostic tests may be able to further reduce the risk of early-onset GBS infection. We report a clinical evaluation of the Xpert GBS LB assay, a molecular diagnostic test for the identification of GBS from broth-enriched vaginal/rectal specimens obtained during routine prenatal screening. A total of 826 specimens were collected from women undergoing prenatal screening (35 to 37 weeks' gestation) and tested at one of three clinical centers. Each swab specimen was tested directly prior to enrichment using the Xpert GBS assay. Following 18 to 24 h of broth enrichment, each specimen was tested using the Xpert GBS LB assay and the FDA-cleared Smart GBS assay as a molecular diagnostic comparator. Results obtained using all three molecular tests were compared to those for broth-enriched culture as the gold standard. The sensitivity and specificity of the Xpert GBS LB assay were 99.0% and 92.4%, respectively, compared to those for the gold standard culture. The Smart GBS molecular test demonstrated sensitivity and specificity of 96.8% and 95.5%, respectively. The sensitivities of the two broth-enriched molecular methods were superior to those for direct testing of specimens using the Xpert GBS assay, which demonstrated sensitivity and specificity of 85.7% and 96.2%, respectively. S treptococcus agalactiae (group B Streptococcus [GBS]) is aGram-positive bacterium associated with transient colonization of mucosal membranes throughout the body, including the vagina, gastrointestinal tract, and urethra (1). GBS rarely causes disease in healthy individuals but can cause serious illness in immunocompromised patients, elderly individuals, and newborn infants (2). Of particular concern is neonatal infection caused by vertical transmission during labor and birthing. Transmission from an asymptomatically colonized mother to the neonate can result in early-onset invasive GBS disease, which is a leading cause of sepsis and meningitis in newborns in the United States (3). Early-onset GBS disease in newborns can result in death or longterm disabilities such as mental retardation and hearing or vision loss (4). Because these infections are acquired through direct contact of the neonate with GBS in the mother's urogenital tract during delivery, it has become a universal practice to screen pregnant women for vaginal/rectal colonization with GBS at 35 to 37 weeks' gestation (5). The identification of GBS during routine screening results in administration of intrapartum prophylaxis to mitigate transmission of bacteria and red...

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“…GBS colonizes the maternal genitourinary tract (at reported frequencies from 4 to 36%) during pregnancy in Europe and the United States (2) and may cause an ascending infection after the onset of labor or the preterm rupture of membranes. Neonates may become colonized (in 40 to 70% of the cases [3]) during passage through the birth canal at the time of delivery. Two strategies have significantly reduced the rate of early neonatal GBS colonization and infection (4): (i) late antenatal GBS screening of pregnant women and (ii) intrapartum chemoprophylaxis for colonized women to reduce vertical transmission of GBS.…”

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confidence: 99%

Xpert GBS Assay for Rapid Detection of Group B Streptococcus in Gastric Fluid Samples from Newborns

et al. 2014

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eThe Xpert GBS real-time PCR assay was applied to gastric fluid samples from 143 newborns, and it detected group B streptococcus (GBS) within 1 h for 16 (11.2%) cases, while microscopic examination detected only 2 cases. The sensitivity and specificity of the Xpert GBS were 80% and 100%, respectively, with regard to 20 cases of GBS colonization or infection. Concordance of Xpert GBS results versus culture was 92.3%. This test detects in a timely manner newborns at risk for invasive GBS disease. Early-onset group B streptococcus (GBS) neonatal disease is a serious and frequent complication of birth in developed countries. GBS causes more than one-third of the materno-fetal infections (MFI) of term infants, followed by Escherichia coli and other Streptococcus spp., as well as species now classified in the Enterococcus genus (1). GBS colonizes the maternal genitourinary tract (at reported frequencies from 4 to 36%) during pregnancy in Europe and the United States (2) and may cause an ascending infection after the onset of labor or the preterm rupture of membranes. Neonates may become colonized (in 40 to 70% of the cases [3]) during passage through the birth canal at the time of delivery. Two strategies have significantly reduced the rate of early neonatal GBS colonization and infection (4): (i) late antenatal GBS screening of pregnant women and (ii) intrapartum chemoprophylaxis for colonized women to reduce vertical transmission of GBS. Despite international guidelines, the worldwide incidence rate of GBS neonatal diseases is still 0.23 to 1.22‰ of births (5, 6).Because early detection of infected newborns is clinically difficult and the newborn's health can worsen rapidly, GBS detection for newborns is one of the emergencies in clinical microbiology. Gastric fluid is the usual relevant specimen for GBS detection (7). Its microscopic examination is so far the only bacteriological finding rapidly available for clinicians who suspect an early MFI. GBS microbiological diagnosis is delayed, since it is based on an 18-h culture. Since microscopic examination has a low sensitivity (27.5%) (8), a rapid method of GBS detection that is reasonably sensitive and specific would be valuable in stratifying the risk of MFI among neonates.The Xpert GBS assay (Cepheid) is a marketed real-time PCR for screening maternal carriage by detecting GBS DNA in vaginal or rectal specimens. Recently, two studies have shown its utility when it is performed on vaginal swabs during intrapartum instead of antenatal screening, at 35 to 37 weeks of gestation (9), and on amniotic fluids collected from pregnant women with premature rupture of membranes (10). Our study aimed to evaluate the test's performance when applied to gastric fluid specimens collected from newborns. Our aim was to shorten the time to detect GBScolonized infants and thus help in the diagnosis of invasive GBS materno-fetal infections.We conducted a prospective study at Lariboisière University Hospital (Paris, France), where 2,500 deliveries are processed per year in an IIA matern...

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Evaluation of Universal Antenatal Screening for Group B Streptococcus

Abstract: Recommendations for universal screening were rapidly adopted. Improved management of preterm deliveries and improved collection, processing, and reporting of culture results may prevent additional cases of early-onset group B streptococcal disease.

Cited by 352 publications

References 24 publications

Group B Streptococcus among Pregnant Women and Newborns in Mirzapur, Bangladesh: Colonization, Vertical Transmission, and Serotype Distribution

Group B Streptococcus among Pregnant Women and Newborns in Mirzapur, Bangladesh: Colonization, Vertical Transmission, and Serotype Distribution

Multicenter Clinical Evaluation of the Xpert GBS LB Assay for Detection of Group B Streptococcus in Prenatal Screening Specimens

Xpert GBS Assay for Rapid Detection of Group B Streptococcus in Gastric Fluid Samples from Newborns

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