Dataset Information

Comparison of BD MAX GBS and GenomEra GBS assays for rapid intrapartum PCR detection of vaginal carriage of group B streptococci.

ABSTRACT:

Objective

To compare the diagnostic performance of BD MAX and GenomEra PCR assays for a rapid PCR detection of vaginal carriage of group B streptococci at delivery.

Methods

This is a retrospective laboratory analysis of vaginal swab samples taken intrapartum from a randomly selected cohort of pregnant women giving birth at a single childbirth and maternity unit.

Results

Ninety-one culture-positive and 279 culture-negative vaginal samples were included from a cohort of 902 women. One-hundred-and-two specimens were found positive with the BD MAX and 84 with the GenomEra PCR assay. No statistically significant difference was observed compared to culture, sensitivity of BD MAX 84.6% (77/91) [95%CI 75.5-91.3] and of GenomEra 71.4% (65/91) [95%CI 61.0-80.4]. When compared to a combined reference standard, no statistically significant differences were seen between culture, BD MAX and GenomEra PCR assays. The sensitivities were 82.7% (91/110) [95%CI 74.3-89.3], 87.3% (96/110) [95%CI 79.6-92.9], and 79.1% (87/110) [95%CI 70.3-86.3], respectively.

Conclusion

Both PCR assays performed comparably to culture of the intrapartum vaginal samples. In particular, the GenomEra assay is potentially an easy and rapid on-site PCR test for intrapartum detection of vaginal carriage of group B streptococci at a maternity ward to identify women who should receive intrapartum antibiotic prophylaxis.

SUBMITTER: Andreasen T

PROVIDER: S-EPMC6467400 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Comparison of BD MAX GBS and GenomEra GBS assays for rapid intrapartum PCR detection of vaginal carriage of group B streptococci.

Andreasen Trine T Kjølseth Møller Jens J Rohi Khalil Mohammed M

PloS one 20190416 4

<h4>Objective</h4>To compare the diagnostic performance of BD MAX and GenomEra PCR assays for a rapid PCR detection of vaginal carriage of group B streptococci at delivery.<h4>Methods</h4>This is a retrospective laboratory analysis of vaginal swab samples taken intrapartum from a randomly selected cohort of pregnant women giving birth at a single childbirth and maternity unit.<h4>Results</h4>Ninety-one culture-positive and 279 culture-negative vaginal samples were included from a cohort of 902 w ...[more]

PMID: 30990861

Similar Datasets

Project description:OBJECTIVES:To estimate the potential impact of the addition of culture-based screening for group B streptococcus (GBS) carriage in pregnancy to a risk-based prevention policy in the UK. We aimed to establish agreement within a multidisciplinary group of key stakeholders on the model input parameters. DESIGN:Deterministic model using a consensus approach for the selection of input parameters. SETTING AND PARTICIPANTS:A theoretical annual cohort of 711 999 live births in the UK (excluding births by elective caesarean section). INTERVENTIONS:Culture-based screening for GBS at 35-37 weeks of pregnancy added to the recommended risk-based prevention policy in place on the date of modelling. OUTCOME MEASURES:Outcomes assessed included use of intrapartum antibiotic prophylaxis (IAP), early onset GBS (EOGBS), EOGBS mortality, severe EOGBS-related morbidity and maternal penicillin anaphylaxis. RESULTS:With no prophylaxis strategy, the model estimated that there would be 421 cases of culture positive EOGBS in a year (0.59/1000 live births). In the risk-based prophylaxis scenario, 30 666 women were estimated to receive IAP and 70 cases of EOGBS were prevented. Addition of screening resulted in a further 96 260 women receiving IAP and the prevention of an additional 52 to 57 cases of EOGBS. This resulted in the prevention of three EOGBS deaths and four cases of severe disability. With screening, an additional 1675 to 1854 women receive IAP to prevent one EOGBS case and 24 065 to 32 087 receive IAP to prevent one EOGBS death. CONCLUSIONS:The evidence base available for a broad range of model input parameters was limited, leading to uncertainty in the estimates produced by the model. Where data was limited, the model input parameters were agreed with the multidisciplinary stakeholder group, the first time this has been done to our knowledge. The main impact of screening is likely to be on the large group of low-risk women where the clinical impact of EOGBS tends to be less severe. This model suggests that the reduction in mortality and severe disability due to EOGBS with antenatal GBS screening is likely to be very limited, with a high rate of overdetection and overuse of antibiotics.

Dataset Information

Comparison of BD MAX GBS and GenomEra GBS assays for rapid intrapartum PCR detection of vaginal carriage of group B streptococci.

Objective

Methods

Results

Conclusion

Publications

Comparison of BD MAX GBS and GenomEra GBS assays for rapid intrapartum PCR detection of vaginal carriage of group B streptococci.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets