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

PLoS One. 2019 Apr 16;14(4):e0215314. doi: 10.1371/journal.pone.0215314. eCollection 2019.

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • DNA, Bacterial* / genetics
  • DNA, Bacterial* / isolation & purification
  • Female
  • Humans
  • Parturition
  • Polymerase Chain Reaction*
  • Pregnancy
  • Pregnancy Complications, Infectious* / diagnosis
  • Pregnancy Complications, Infectious* / genetics
  • Pregnancy Complications, Infectious* / microbiology
  • Specimen Handling
  • Streptococcal Infections* / diagnosis
  • Streptococcal Infections* / genetics
  • Streptococcal Infections* / prevention & control
  • Streptococcus agalactiae / genetics*
  • Vagina / microbiology*

Substances

  • DNA, Bacterial

Grants and funding

This work was founded in part from the Research Council at Lillebaelt Hospital and in part by the Region of Southern Denmark. GenomEra kits were provided free of charge by Abacus Diagnostica. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.