Medical Devices: Evidence and Research (May 2016)
ROM Plus®: accurate point-of-care detection of ruptured fetal membranes
Abstract
Ross W McQuivey,1 Jon E Block2 1Clinical Affairs, Clinical Innovations, Salt Lake City, UT, 2Independent Clinical Consultant, San Francisco, CA, USAAbstract: Accurate and timely diagnosis of rupture of fetal membranes is imperative to inform and guide gestational age-specific interventions to optimize perinatal outcomes and reduce the risk of serious complications, including preterm delivery and infections. The ROM Plus is a rapid, point-of-care, qualitative immunochromatographic diagnostic test that uses a unique monoclonal/polyclonal antibody approach to detect two different proteins found in amniotic fluid at high concentrations: alpha-fetoprotein and insulin-like growth factor binding protein-1. Clinical study results have uniformly demonstrated high diagnostic accuracy and performance characteristics with this point-of-care test that exceeds conventional clinical testing with external laboratory evaluation. The description, indications for use, procedural steps, and laboratory and clinical characterization of this assay are presented in this article.Keywords: ROM Plus®, premature rupture of membranes, point-of-care immunoassay, insulin-like growth factor binding protein-1, IGFBP-1, placental protein 12, PP12, alpha-fetoprotein, AFP
