ROM Plus&amp;reg;: accurate point-of-care detection of ruptured fetal membranes

McQuivey, Ross W.; Block, Jon E.

doi:10.2147/mder.s106106

Cited by 4 publications

(2 citation statements)

References 32 publications

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“…At the time of clinical presentation, both immunoassay tests were performed simultaneously on each patient to determine presence or absence of ROM. The methodological and procedural details of both tests have been detailed previously [ 18 , 23 , 24 ]. In accordance with institutional regulations, both immunoassays were evaluated by authorized and trained personnel in the central hospital laboratory.…”

Section: Methodsmentioning

confidence: 99%

“…The first generation of these tests employed a monoclonal antibody approach focusing on insulin-like growth factor binding protein-1 (IGFBP-1, aka placental protein 12 [PP12]) and placental alpha microglobulin-1 (PAMG-1) [ 17 – 21 ]. More recently, a combined monoclonal/polyclonal antibody immunoassay has been developed to detect two different proteins found in amniotic fluid at high concentrations [ 22 , 23 ]. This study was undertaken to evaluate the diagnostic accuracy for ROM detection of an original monoclonal antibody immunoassay test compared with a newer monoclonal/polyclonal test.…”

Section: Introductionmentioning

confidence: 99%

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Comparison of rapid immunoassays for rupture of fetal membranes

Igbinosa

Moore

Johnson

et al. 2017

BMC Pregnancy Childbirth

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BackgroundRupture of membranes (ROM) before the onset of uterine contractions, particularly in pregnancies less than 37 weeks gestational age, is a common diagnostic problem in obstetrical practice. Timely detection of ROM is vital to support gestational age-specific interventions to optimize perinatal outcomes and minimize the risk of serious complications such as preterm delivery, fetal distress and maternal/fetal infections. Rapid bedside immunoassay tests designed to detect amniotic fluid proteins in cervicovaginal fluids have emerged as valuable clinical tools to provide timely ROM diagnosis.MethodsIn this prospective observational study, two commercially-available immunoassay tests (ROM Plus®, AmniSure®) were evaluated concurrently in 111 pregnant women who presented with the chief complaint of ROM. Immunoassay results were compared to clinical parameters for determining ROM via comprehensive, retrospective clinical chart review. Diagnostic performance characteristics were calculated including sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy.ResultsOverall, diagnostic performance characteristics were robust and similar between ROM Plus® and AmniSure®, respectively: sensitivity (96.4 and 89.3%), specificity (98.8 and 100%), PPV (96.4 and 100%), NPV (98.8% and 96.5) and accuracy (98.2 and 97.3%). For term patients (≥37 weeks gestation), the sensitivities were 93.8 and 81.3% and specificities were 97.1 and 100% for ROM Plus® and AmniSure®, respectively. For preterm patients (<37 weeks gestation), both immunoassay tests provided exact concordance with clinical confirmation of ROM resulting in 100% diagnostic accuracy.ConclusionsBoth rapid immunoassay tests provided similarly excellent diagnostic accuracy for the rapid detection of ROM with only two discrepant results for ROM Plus® and three discrepant results for AmniSure® compared to clinical confirmation. The findings from this study recommend these tests for pregnant women presenting with suspected ROM to guide correct clinical management decisions to improve obstetrical and neonatal outcomes.Trial registrationClinicalTrials.gov, NCT02208011 (1 August 2014).

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Comparison of rapid immunoassays for rupture of fetal membranes

Igbinosa

Moore

Johnson

et al. 2017

BMC Pregnancy Childbirth

View full text Add to dashboard Cite

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Point-of-care diagnostics to improve maternal and neonatal health in low-resource settings

et al. 2017

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Each day, approximately 830 women and 7,400 newborns die from complications during pregnancy and childbirth. Improving maternal and neonatal health will require bringing rapid diagnosis and treatment to the point of care in low-resource settings. However, to date there are few diagnostic tools available that can be used at the point of care to detect the leading causes of maternal and neonatal mortality in low-resource settings. Here we review both commercially available diagnostics and technologies that are currently in development to detect the leading causes of maternal and neonatal mortality, highlighting key gaps in development where innovative design could increase access to technology and enable rapid diagnosis at the bedside.

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