789: Comparison of rapid immunoassays for the detection of ruptured membranes

Spontaneous rupture of membranes (ROM) before the onset of uterine contractions 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. Compare diagnostic performance of two rapid bedside immunoassay tests designed to detect amniotic fluid proteins in cervicovaginal fluids. In this prospective observational study, two commercially-available immunoassay tests (ROM Plus®, AmniSure®) were evaluated concurrently in 111 pregnant patients who presented with probable ROM. Immunoassay results were compared to clinical confirmation via comprehensive clinical chart review. Diagnostic performance characteristics were calculated including sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV). Overall, diagnostic performance characteristics were 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. Both rapid immunoassay tests provided similarly 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 patients presenting with suspected ROM to guide correct clinical management decisions to improve obstetrical and neonatal outcomes.