ROM Plus(®): accurate point-of-care detection of ruptured fetal membranes

Abstract

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: AFP; IGFBP-1; PP12; ROM Plus®; alpha-fetoprotein; insulin-like growth factor binding protein-1; placental protein 12; point-of-care immunoassay; premature rupture of membranes.

Figure 1

ROM Plus^® fetal membrane rupture test. Abbreviations: C, control; AF, amniotic fluid.

Figure 2

ROM Plus^® point-of-care procedural steps. Notes: (A) The sterile swab is removed from its package to collect a sample from the surface of the vagina being careful not to touch anything prior to its insertion. The swab is inserted into the vagina 5–7 cm deep and then withdrawn after a minimum of 15 seconds. (B) The swab tip is placed in the vial and mixed with the buffer solution. After breaking off the swab tip at the scored mark, the tip is left in the vial. For point-of-care applications, the drop dispenser lid is employed and the tip is allowed to remain in the buffer solution for a minimum of 15 seconds. (C) 4–6 drops of the sample/buffer solution are added to the sample well of the ROM Plus cassette and the timer is started. The results can be visualized in 5–20 minutes. (D) If the control line is visible (C), the test result is negative. If both the control (C) and the test line (AF) are visible, the result is positive. If no lines are visible, or just the test line (AF) is visible, the test result is invalid and should be repeated. Abbreviation: AF, amniotic fluid.