Proteins in leaked amniotic fluid as biomarkers diagnostic for prelabor rupture of membranes

Abstract Purpose : Early diagnosis of prelabor rupture of membranes (PROM) is essential to protect mother and fetus from intra‐uterus infection and preterm birth. A simple and rapid bedside test would help clinicians confirm the diagnosis for early treatment. Experimental design : A protein array was used to screen cervical–vaginal fluid (CVF) and amniotic fluid (AF) samples collected from normal and PROM pregnant women. Enzyme‐linked immunosorbent assay was used to quantify two novel and potentially useful analytes, soluble intercellular adhesion molecule‐1 (sICAM‐1) and Axl receptor tyrosine kinase (Axl). Results : The mean concentration of sICAM‐1 and Axl was 85 and 482 times higher separately in 30 healthy AF samples than in 110 CVF samples of normal pregnancies. Comparing 110 CVF samples of PROM/Preterm PROM with 110 CVF samples of normal pregnancies, the diagnostic value for PROM was demonstrated by their high sensitivity and specificity (96.4 and 92.7%, respectively, for sICAM‐1, and 92.4 and 90.4%, respectively, for Axl). Conclusions and clinical relevance : The results indicate that sICAM‐1 and Axl in AF leaked to vagina are sensitive and specific biomarkers for the diagnosis of PROM. Furthermore, sICAM‐1 or Axl can be developed into a rapid strip test for bedside use.