Publication:

AmnioQuick® Duo+ for diagnosis of premature fetal membranes rupture

Background Failure to identify women with premature fetal membranes rupture associated with infectious morbidities. Evaluation of the accuracy of AmnioQuick® Duo+ in diagnosing premature fetal membranes rupture compared to conventional diagnostic tests was the aim of this study.

Methods 220 pregnant women ≥37 and <39 weeks` gestation studied and classified into two groups; study group (premature fetal membranes rupture) and control group (no premature fetal membranes rupture). Participants examined by trans-abdominal ultrasound (TAS) and vaginal speculum to visualize amnion leaking and for collection of samples for fern, nitrazine and AmnioQuick® Duo+ tests on admission. A final diagnosis whether the studied women had PROM or not at the initial presentation made after delivery.

Results Sensitivity and specificity of the AmnioQuick® Duo+ to diagnose PROM was 93.6% and 86.4%; respectively compared with 72.7% and 80.9%; respectively for fern test and 76.4% and 83.6%; respectively for nitrazine test. Positive predictive value, negative predictive value and accuracy of AmnioQuick® Duo+ to detect PROM were 87.3%, 93.1% and 90%; respectively compared with 79.2%, 74.8% and 76.8%; respectively for fern test and 82.4%, 77.97% and 80%; respectively for nitrazine test. AmnioQuick® Duo+ test had higher accuracy to detect premature fetal membranes rupture compared to conventional diagnostic tests.

Conclusions AmnioQuick® Duo+ is accurate bedside immunoassay test, better than the individual conventional diagnostic tests and can used as complementary test to improve the management of women with women premature fetal membranes rupture.