Diagnostic Accuracy of IGFBP-1 (ACTIM-PROM) Versus the Nitrazine Test for Preterm Premature Rupture of Membranes

Abstract

Objective: To evaluate the diagnostic performance of insulin-like growth factor-binding protein-1 (IGFBP-1; ACTIM PROM)
compared with the nitrazine test for the diagnosis of preterm premature rupture of membranes (PPROM).

Methods: This observational analytical study included 30 pregnant women, comprising 15 women with PPROM and 15
controls. Posterior fornix fluid collected during a sterile speculum examination was analyzed using both the nitrazine test and
the ACTIM PROM immunoassay.

Results: The nitrazine test demonstrated a sensitivity of 80.0%, specificity of 73.3%, and overall diagnostic accuracy of 76.6%.
ACTIM PROM demonstrated a sensitivity of 93.3%, specificity of 100%, and overall diagnostic accuracy of 96.6%. ACTIM PROM
showed significantly higher specificity than the nitrazine test, whereas no significant difference was observed in sensitivity.

Conclusion: ACTIM PROM demonstrated superior specificity and overall diagnostic accuracy compared with the nitrazine test
and may serve as a reliable diagnostic tool for the diagnosis of PPROM.

Keywords: ACTIM PROM; diagnostic accuracy; IGFBP-1; nitrazine test; preterm premature rupture of membranes.