Comparison of rapid immunoassays for rupture of fetal membranes

Abstract

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).

Cytokines in Preterm Delivery: Proposal of a New Diagnostic Algorithm

“…Varied etiopathogenesis of preterm delivery resulted from the fact that in the past decade identification of numerous cytokines and molecules connected with preterm delivery has not brought any significant progress in the differential diagnosis of early preterm delivery and false preterm delivery. The majority of the commercially available tests is based on the estimation of insulin-like growth factor binding protein (IGFBP-1) in combination with other molecules, for example, alpha-fetoprotein (AFP) or interleukin 6 (IL-6) [ 15 – 18 ]. Additionally, a majority of these immunoassays are used for detection and confirmation of fetal membrane rupture.…”

Utility of insulin-like growth factor-binding protein type 1 in premature membrane rupture

“…Aunque es considerado por muchos investigadores como el estándar de oro para el diagnóstico de RPM, (11,13,14) la prueba de la amniocentesis es un procedimiento invasivo con riesgos inherentes que incluyen sangrado (desprendimiento de la placenta), infección, rotura de membranas de forma iatrogénica, y el aborto involuntario. Por estas razones, se necesita urgentemente una prueba rápida, precisa, barata y no invasiva para el diagnóstico de la RPM (15).…”

Middle-East OBGYN Graduate Education (MOGGE) Foundation Practice Guidelines: Prelabor rupture of membranes; Practice guideline No. 01-O-19

“…Another test, called ROM Plus® (Clinical Innovations, Salt Lake City, UT USA), is designed to detect both placental protein 12 and alpha-fetoprotein as indicators of amniotic fluid. Compared to Amnisure, a prospective study on 111 women showed comparability in diagnostic accuracy [19].…”