Clinical utility of novel point-of-care Amnioquick card tests for the assessment of pre-labor rupture of fetal membranes: a narrative review

Abstract

INTRODUCTION: Pre-labor rupture of membranes (PROM) remains a major contributor to adverse maternal and neonatal outcomes, particularly in settings where diagnostic uncertainty delays appropriate intervention. Novel point-of-care biochemical assays, including the Amnioquick card test, have emerged to address the limitations of conventional bedside methods in PROM diagnosis. AREAS COVERED: This narrative review synthesizes evidence from nine peer-reviewed studies encompassing 1,255 participants to evaluate the diagnostic accuracy, clinical applicability, and limitations of the Amnioquick assays. Reported sensitivity ranged from 93.3% to 100%, specificity (86.4%-100%), positive predictive value (87.3%-100%), negative predictive value (73.7%-100%), and overall accuracy from 90.0% to 99.1%. These results demonstrate robust diagnostic performance across diverse clinical and geographic contexts, with consistent findings even in equivocal samples. EXPERT OPINION: Amnioquick provides rapid, reliable confirmation of PROM at bedside using dual markers insulin-like growth factor binding protein-1 (IGFBP-1) and alpha-fetoprotein (AFP), improving accuracy over single marker or pH tests and reducing unnecessary interventions. Its simplicity, minimal infrastructure needs, and quick results make it suitable for low and middle-income settings. Barriers such as cost, limited multicentre validation, and reduced reliability in contaminated samples remain. Future goals include triton-free formulation, integration with digital readers and electronic decision tools, and large multicentre outcome-linked evaluations.