Comparison of the accuracy and reliability of the AmniSure, AMNIOQUICK, and AL-SENSE tests for early diagnosis of premature rupture of membranes

Abstract

Objective: To compare the accuracy and reliability of the AmniSure, AMNIOQUICK, and AL-SENSE tests with conventional tests to diagnose suspected premature rupture of membranes (PROM).

Methods: A prospective cohort study of 60 pregnant women at 25-36 weeks of pregnancy with suspected PROM was conducted between January and April 2015. AmniSure (Qiagen Sciences LLC, Germantown, MD, USA), AMNIOQUICK (BIOSYNEX, Strasbourg, France), and AL-SENSE (Common Sense Ltd, Caesarea, Israel) tests were performed after conventional tests (ultrasonography, pooling, nitrazine, and fern tests) and women were followed-up for 7 days. Sensitivity, specificity, and diagnostic accuracy, among others, were assessed and compared.

Results: For women with a confirmed diagnosis of PROM, the sensitivity and specificity of conventional tests were 93.7% and 100.0%, respectively; diagnostic accuracy was 98.3%. Sensitivity, specificity, and diagnostic accuracy were all 100.0% for AmniSure. Sensitivity, specificity, and diagnostic accuracy for AMNIOQUICK were 75.0%, 97.7%, and 91.6%, respectively. Sensitivity, specificity, and diagnostic accuracy were 75.0%, 86.3%, 83.3%, respectively, for the AL-SENSE pad test.

Conclusion: The AmniSure test was most sensitive and specific for diagnosing PROM compared with the other tests and is reliable and usable.

Keywords: PPROM; PROM; AL-SENSE test; AMNIOQUICK test; AmniSure test; Premature rupture of membranes.