Performance indices of AmnioQuick Duo+ versus placental α‐microglobulin‐1 tests for women with prolonged premature rupture of membranes

Objective To compare AmnioQuick Duo+ versus the placental α‐microglobulin‐1 ( PAMG ‐1) test for diagnosis of prolonged premature rupture of membranes ( PROM ). Methods A multicenter prospective cohort study included women with suspected PROM at six tertiary institutions in southern Nigeria between January 1 and December 31, 2015. The inclusion criteria were features of PROM lasting at least 24 hours and a pregnancy duration of more than 24 weeks. AmnioQuick Duo+ (Biosynex, Strasbourg, France) and PAMG ‐1 (AmniSure International, Boston, USA ) tests were used to diagnose PROM , which was confirmed after delivery by any two of the following criteria: delivery within 48 hours to 7 days, chorioamnionitis, membranes perceptibly ruptured at delivery, and adverse perinatal outcomes considerably associated with prolonged PROM . Results Of 100 women assessed for eligibility, 99 were included. Sensitivity, specificity, and accuracy were, respectively, 97.3%, 100%, and 95.9% for AmnioQuick Duo+, and 93.2%, 100%, and 90.4% for PAMG ‐1. The differences were not significant and the diagnostic discordant rate between the two tests was 3.1%. In equivocal cases (i.e., negative pooling test result), AmnioQuick Duo+ and PAMG ‐1 performed equally (diagnostic accuracy, 100% vs 97.7%; P >0.99). Conclusion For diagnosis of PROM , AmnioQuick Duo+ was found to be non‐inferior and comparable in accuracy to the PAMG ‐1 test, with a diagnostic discordance rate of 3.1%.