Clinical evaluation of soluble intercellular adhesion molecule-1 and insulin like growth factor-binding protein-1-based rapid immunoassays for the diagnosis of prelabor rupture of membranes

J Perinat Med. 2013 Mar;41(2):181-5. doi: 10.1515/jpm-2012-0094.

Abstract

Aims: To evaluate the clinical value of two rapid tests, based on soluble intercellular adhesion molecule-1 (Leakection) and insulinlike growth factor-binding protein-1 (Amnioquick), for the diagnosis of prelabor rupture of membranes.

Methods: A total of 200 pregnant women were recruited in this study: 100 pregnant women with membrane rupture and 100 healthy pregnant women as controls. Patients and controls were randomly divided into Leakection and Amnioquick groups, respectively. Sensitivity and specificity were calculated on the basis of the detection results.

Results: For the 100 women tested with Leakection, the sensitivity and specificity was 94% and 96%, respectively; the total accuracy was 95%. For the 100 women tested with Amnioquick, the sensitivity and specificity was 80% and 100%, respectively; the total accuracy was 90%.

Conclusions: Both Leakection and Amnioquick are noninvasive and inexpensive rapid tests for the diagnosis of premature or prelabor rupture of membranes with high sensitivity and specificity. These tests could greatly help the timely diagnosis of premature or prelabor rupture of membranes in clinical practice.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Amniotic Fluid / chemistry*
  • Biomarkers / analysis
  • Body Fluids / chemistry
  • Case-Control Studies
  • Cervix Uteri / chemistry
  • Female
  • Fetal Membranes, Premature Rupture / diagnosis*
  • Fetal Membranes, Premature Rupture / metabolism*
  • Humans
  • Immunoassay / methods
  • Immunoassay / statistics & numerical data
  • Insulin-Like Growth Factor Binding Protein 1 / analysis*
  • Intercellular Adhesion Molecule-1 / analysis*
  • Predictive Value of Tests
  • Pregnancy
  • Solubility
  • Young Adult

Substances

  • Biomarkers
  • ICAM1 protein, human
  • IGFBP1 protein, human
  • Insulin-Like Growth Factor Binding Protein 1
  • Intercellular Adhesion Molecule-1