ABSTRACT
The purpose of this study was to compare the AmniSure rapid immunoassay with standard
methods for diagnosing rupture of fetal membranes. Patients presenting with signs/symptoms
of membrane rupture between 15 and 42 weeks of gestation were invited to participate.
Standard/control methods were performed to establish a diagnosis and compare it with
AmniSure results. AmniSure performance metrics and their 95% confidence intervals
were calculated. A total of 203 patients agreed to participate. Discrepancies between
the control method and AmniSure were noted in seven cases. In these cases, true positives
and negatives were determined by retesting with the control method and AmniSure and
by noting sonographic evidence of low amniotic fluid. In the final analysis, the AmniSure
diagnostic test demonstrated a sensitivity of 98.9%, specificity of 100%, positive
predictive value of 100%, and a negative predictive value of 99.1%. AmniSure is highly
accurate in diagnosing fetal membrane rupture.
KEYWORDS
AmniSure ROM test - rupture of membranes - PAMG-1 immunoassay
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Larry CousinsM.D.
Sharp Mary Birch Hospital for Women
3003 Health Center Drive, San Diego, CA 92123
