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%.