Abstract
<p style="margin-bottom: 0in;"><span style="color: #000000;"><span style="font-family: Times New Roman,serif;"><span style="font-size: small;"><span style="color: #231f20;"><em><strong>Objectives: </strong></em></span><span style="color: #231f20;"><span style="font-weight: normal;">To confirm three point of care commercial tests for rupture of membranes </span></span><span style="color: #231f20;">consistently and accurately detect amniotic fluids from pregnant women, and they are practical and easy to use.</span></span></span></span> <p style="margin-bottom: 0in;"><span style="color: #000000;"><span style="font-family: Times New Roman,serif;"><span style="font-size: small;"><span style="color: #231f20;"><em><strong>Methods: </strong></em></span><span style="color: #231f20;">Samples of fresh amniotic fluid were collected in a syringe taken at time of C section and run on kits (Actim™PROM, AmniSure®, and ROM +plus®) from three commercially available point of care rupture of membrane tests. Samples were sent to an independent laboratory for ELISA analysis of these amniotic fluid proteins (insulin-like growth factor binding protein (IGFBP-1) and alpha-Fetal protein (AFP). Test results of known amniotic fluid on Actim™PROM, AmniSure®, and ROM +plus®, along with ease of use of comments. False negatives were used to determine accuracy of tests.</span></span></span></span> <p style="margin-bottom: 0in;"><span style="color: #000000;"><span style="font-family: Times New Roman,serif;"><span style="font-size: small;"><span style="color: #231f20;"><em><strong>Results: </strong></em></span><span style="color: #231f20;">Correct results were obtained in 96.8%, 95.8%, and 98.9% respectively for Actim™PROM, AmniSure®, and ROM +plus®. Users reported ROM +plus® was easiest to use.</span></span></span></span> <p style="margin-bottom: 0in;"><span style="font-family: Times New Roman,serif;"><span style="font-size: small;"><span style="color: #231f20;"><em><strong>Conclusions: </strong></em></span><span style="color: #231f20;">ROM +plus®. provided the least amount of false negative testing on known samples of amniotic fluid. ROM +plus® was considered most simple and easiest to use and detects two different amniotic fluid proteins while the other tests detect one protein.</span></span></span> <span style="font-weight: normal;">DOI: <a href="http://dx.doi.org/10.4038/sljog.v35i4.6587">http://dx.doi.org/10.4038/sljog.v35i4.6587</a></span> <p style="margin-bottom: 0in;"><em><span style="font-weight: normal;">Sri Lanka Journal of Obstetrics and Gynaecology </span></em><span style="font-weight: normal;">2013; 35: 116-121</span>
Highlights
Premature rupture of membranes (PROM), defined as spontaneous rupture of membranes (ROM) before the onset of uterine contractions, is one of the most common diagnostic dilemmas in contemporary obstetric practice
To demonstrate the wide variability of concentrations of proteins used by diagnostic tests to determine rupture of membrane (ROM), using uncontaminated samples of amniotic fluid obtained directly from the placenta during c-section deliveries
During the period from October 2011 to May 2012, 95 women from whom clear amniotic fluid samples were obtained were enrolled into the study
Summary
Inclusion criteria for the study were healthy pregnant women 16 years and older in which a sample of known amniotic fluid not contaminated with blood was collected during caesarean delivery. The clinicians who performed the tests were practicing labour and delivery staff members who normally assessed patients for possible ROM. They were all familiar with the methods of performing the tests according to the manufacturers’ instructions. To demonstrate the wide variability of concentrations of proteins used by diagnostic tests to determine rupture of membrane (ROM), using uncontaminated samples of amniotic fluid obtained directly from the placenta during c-section deliveries. Compute the sensitivity of three commerical diagnostic tests to detect amniotic fluid in these samples. These tests were Actim TMProm, AmniSureR and ROM+plus ®.
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