Multicenter Study of a Rapid Molecular-Based Assay for the Diagnosis of Group B Streptococcus Colonization in Pregnant Women

Davies, H. Dele; Miller, Mark A.; Faro, Sebastian; Gregson, Dan; Kehl, Sue C.; Jordan, Jeanne A.

doi:10.1086/424518

Cited by 150 publications

(109 citation statements)

References 33 publications

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“…In a clinical trial published in 2004, the IDI-Strep B TM assay demonstrated a sensitivity of 94 % and a specificity of 96 % compared with intrapartum cultures. It was revealed to be more sensitive than an antenatal reference culture or a risk-based strategy to predict GBS colonization status at delivery [30]. The superiority of the intrapartum molecular detection of GBS when compared with antenatal culture was confirmed by a Canadian group [31].…”

Section: Polymerase Chain Reactionmentioning

confidence: 92%

Molecular-based Screening for Perinatal Group B Streptococcal Infection: Implications for Prevention and Therapy

2013

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Group B streptococci (GBS) are a leading cause of infectious neonatal morbidity and mortality. Timely and accurate identification of colonized pregnant women is imperative to implement intrapartum antibioprophylaxis (IAP) to reduce the risk of early neonatal sepsis. Current guidelines recommend screening for GBS carriage with vaginal-rectal cultures. However, cultures require 24-72 h, thus precluding their use for intrapartum screening and these are only performed at 35-37 weeks gestation. New rapid molecular-based tests can detect GBS within hours. They have the potential to be used intrapartum and to allow for selective IAP in women carrying GBS. An advantage is that they can sometimes be performed by non-laboratory staff in the labor suite, thus avoiding delays in sample transfers to the microbiology laboratory. Another possible use of molecular-based assays is for the diagnosis of neonatal sepsis, where tests with a short turnaround time and high sensitivity and specificity are crucial. In this situation, the detection of microorganisms once antibiotic therapy has already been started is important, as treatment is started immediately once sepsis is suspected without waiting for microbiological confirmation. In this article, we discuss the state-of-the-art molecular-based tests available for GBS screening during pregnancy, as well as their implications for IAP for the diagnosis and prevention of neonatal sepsis.

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Section: Polymerase Chain Reactionmentioning

confidence: 92%

Molecular-based Screening for Perinatal Group B Streptococcal Infection: Implications for Prevention and Therapy

2013

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“…Rapid real-time PCR assays for GBS detection have been further developed and their performances have been evaluated these last years as summed up in Table 2. When compared to enriched GBS cultures, sensitivity and specificity for PCR tests range from 62.5%-100% and 84.6-100% while PPV and NPV range from 65-100% and 92.3-100% [80,82,[84][85][86][103][104][105][106][107][108][109][110][111]. Today, real-time PCRbased tests (NAAT) can equal or surpass the sensitivity of antenatal culture at 35-37 weeks' gestation and compare favorably with reference to bacterial culture performed at presentation for delivery taken as gold standard for the detection of GBS colonization [80,82,101,102,112].…”

Section: Non-culture Methods For Intrapartum Specimen Processingmentioning

confidence: 98%

“…Studies have showed utility to assess intrapartum GBS colonization and thus avoiding need for antenatal screening, but they remain limited [80]. At least, rapid real-time PCR assays offer the advantage of GBS detection among women delivering preterm, women without antenatal care or in whom no antenatal culture was performed, or women for whom no result was available at delivery as mentioned in the revised 2010 CDC recommendations.…”

Section: Non-culture Methods For Intrapartum Specimen Processingmentioning

confidence: 99%

“…However the expected predictive values were too optimistic. In studies evaluating antenatal culture to predict intrapartum status for genital colonization with GBS, reported sensitivities range from 51% to 87%, specificities from 93.7% to 97.1%, positive and negative predictive values from 60.6% to 87% and from 88% to 96% [77,[79][80][81][82][83][84][85][86][87].…”

Section: Timing Of Screeningmentioning

confidence: 99%

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Intrapartum GBS screening and antibiotic prophylaxis: a European consensus conference

Renzo

Melin²,

Berardi

et al. 2014

The Journal of Maternal-Fetal & Neonatal Medicine

156

135

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Group B streptococcus (GBS) remains worldwide a leading cause of severe neonatal disease. Since the end of the 1990s, various strategies for prevention of the early onset neonatal disease have been implemented and have evolved. When a universal antenatal GBS screening-based strategy is used to identify women who are given an intrapartum antimicrobial prophylaxis, a substantial reduction of incidence up to 80% has been reported in the USA as in other countries including European countries. However recommendations are still a matter of debate due to challenges and controversies on how best to identify candidates for prophylaxis and to drawbacks of intrapartum administration of antibiotics. In Europe, some countries recommend either antenatal GBS screening or risk-based strategies, or any combination, and others do not have national or any other kind of guidelines for prevention of GBS perinatal disease. Furthermore, accurate population-based data of incidence of GBS neonatal disease are not available in some countries and hamper good effectiveness evaluation of prevention strategies. To facilitate a consensus towards European guidelines for the management of pregnant women in labor and during pregnancy for the prevention of GBS perinatal disease, a conference was organized in 2013 with a group of experts in neonatology, gynecologyobstetrics and clinical microbiology coming from European representative countries. The group reviewed available data, identified areas where results were suboptimal, where revised procedures and new technologies could improve current practices for prevention of perinatal GBS disease. The key decision issued after the conference is to recommend intrapartum antimicrobial prophylaxis based on a universal intrapartum GBS screening strategy using a rapid real time testing.

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“…La colonización se produce por la exposición del recién nacido al microorganismo durante el parto a partir del tracto genital materno colonizado, o en el útero por vía ascendente, siendo la tasa de transmisión vertical del 50% [1][2][3][4] . La importancia de realizar tamización de colonización de las gestantes antes del parto, radica en definir el empleo de antibióticos profilácticos para prevenir el desarrollo de la infección.…”

Section: Introductionunclassified

Evaluación de una técnica de PCR en tiempo real para determinar colonización por Streptococcus agalactiae en mujeres gestantes de Medellín que consultan en Dinamica IPS

Duque

Sánchez

Gómez³

et al. 2017

Infect

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ResumenObjetivo: Evaluar una técnica de PCR en tiempo real para determinar colonización por Streptococcus agalactiae en mujeres gestantes de Medellín. Materiales Y Métodos: Se realizó un estudio descriptivo prospectivo, en 150 mujeres gestantes, seleccionadas de forma aleatoria, en una IPS en el periodo comprendido entre Enero-Julio 2016. Criterio de inclusión: ser gestante entre la semana 35-37, declaración voluntaria de participación en el estudio y de exclusión el uso de antibióticos. A las pacientes, se les tomó muestra con hisopo del introito vaginal y de la región anal. Las muestras se procesaron para qPCR, cultivo en caldo selectivo con posterior siembra en agar sangre de carnero y medio cromogénico para S. agalactiae STRB (ChromIDTMStrepto,BioMérieux SA.). Resultados: La prevalencia de colonización por S. agalactiae en las gestantes fue de 20,9% y 22,3 % en agar sangre y agar cromogénico STRB respectivamente, mientras que mediante PCR en tiempo real la prevalencia fue de 36%. Al comparar la qPCR con la prueba de oro se encontró: sensibilidad 79,31% (IC del 95%: 0,61-0,90), especificidad 75,45% (IC del 95%: 0,66-0,82), valor predictivo positivo 46% (IC del 95%:0,32-0,59) y negativo 93,2% (IC del 95%: 0,86-0,96). Discusión: El empleo de la qPCR permitió aumentar la sensibilidad y la oportunidad diagnostica (El tiempo requerido empleando el cultivo fue de 24-48 horas y por qPCR 6 horas), impactando la reducción de riesgos de transmisión neonatal de S. agalactiae, lo cual podría representar una disminución en días de estancia y costos hospitalarios por una infección prevenible. Palabras clave: Streptococcus agalactiae, Cultivo, PCR en tiempo real, Colonización Evaluation of a real-time PCR technique to determine colonization by Streptococcus agalactiae in pregnant women of Medellín who consult in Dinamica IPS AbstractObjective: To evaluate a real-time qPCR technique to determine colonization by Streptococcus agalactiae in pregnant women from Medellín. Materials and Methods: A prospective and descriptive study was conducted in 150 pregnant women, randomly selected, at an IPS between January and July 2016. Inclusion criteria: gestation period week 35-37, voluntary declaration of participation in the study. Exclusion criteria: the use of antibiotics. Samples were taken from the vaginal introitus and the anal region using a hyssop and processed for qPCR as well as the gold standard test [selective broth culture with subsequent culture in blood agar and chromogenic medium for S. agalactiae STRB (ChromIDTMStrepto, BioMérieux SA)].Results: The prevalence of colonization by S. agalactiae in pregnant women was 20.9% and 22.3% in blood agar and chromogenic agar STRB respectively, whereas using qPCR the prevalence was 36.0%. The time required using the culture was 24-48h compared to 6h for qPCR. Our data comparing qPCR with the gold standard test showed: sensitivity 79.31% (95% CI: 0.61-0.90), specificity 75.45% (95% CI: 0.66-0.82), positive predictive value 46.0% (95% CI: 0.32-0.59) and negative 93.2% (95% CI: 0.86-0....

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Multicenter Study of a Rapid Molecular-Based Assay for the Diagnosis of Group B Streptococcus Colonization in Pregnant Women

Abstract: Use of this test for determination of GBS colonization during labor is highly sensitive and specific and may lead to a further reduction in rates of neonatal GBS disease.

Cited by 150 publications

References 33 publications

Molecular-based Screening for Perinatal Group B Streptococcal Infection: Implications for Prevention and Therapy

Molecular-based Screening for Perinatal Group B Streptococcal Infection: Implications for Prevention and Therapy

Intrapartum GBS screening and antibiotic prophylaxis: a European consensus conference

Evaluación de una técnica de PCR en tiempo real para determinar colonización por Streptococcus agalactiae en mujeres gestantes de Medellín que consultan en Dinamica IPS

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