TY - JOUR
T1 - Performance indices of AmnioQuick Duo+ versus placental α-microglobulin-1 tests for women with prolonged premature rupture of membranes
AU - Eleje, George U.
AU - Ezugwu, Euzebus C.
AU - Ezebialu, Ifeanyichukwu U.
AU - Ojiegbe, Nnabuike O.
AU - Egeonu, Richard O.
AU - Obiora, Chukwudi C.
AU - Okafor, Chigozie G.
AU - Ikechebelu, Joseph I.
AU - Eke, Ahizechukwu C.
N1 - Publisher Copyright:
© 2018 International Federation of Gynecology and Obstetrics
PY - 2019/2
Y1 - 2019/2
N2 - 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%.
AB - 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%.
KW - Accuracy
KW - AmnioQuick Duo+
KW - Equivocal
KW - PAMG-1
KW - PROM
KW - Prolonged
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U2 - 10.1002/ijgo.12703
DO - 10.1002/ijgo.12703
M3 - Article
C2 - 30387138
AN - SCOPUS:85056799662
SN - 0020-7292
VL - 144
SP - 180
EP - 186
JO - International Journal of Gynecology and Obstetrics
JF - International Journal of Gynecology and Obstetrics
IS - 2
ER -