Summary of Bornstein et al studies
Research by Bornstein al1 carried out a multicenter, open-label study in which 339 pregnant women (age 18 to 45 years, minimum 16 weeks' gestation, presenting with unexplained vaginal wetness) were enrolled.
The TPL accurately detected 154 of the 161 subjects found to have amniotic fluid leakage by
the standard diagnosis (Speculum examination, Microscopic ferning test, and pH test); thus,
the sensitivity of the TPL was 95.65% (% true positive readings).
The specificity was 84.46% (% true negative readings), as the TPL demonstrated a negative
result for 125 of the 148 subjects whose clinical diagnosis was negative for amniotic fluid leakage.
The overall agreement between the TPL readings of the clinician and that of the subject was 97.40%.
A further study by Bornstein et al2 looked at the diagnostic efficacy of AL-SENSE™ panty-liner in detecting premature rupture of membranes (PROM).
The result of the AL-SENSE™ strip test was compared with the clinical diagnosis, which was based on speculum examination, Microscopic ferning test, and pH test.
Summary of Mulhair et al
A further research study by Mulhair L et al3 carried out in UK inner-city teaching hospital Antenatal Day Unit, in which 139 pregnant women (minimum 18 weeks’ gestation) were enrolled.
The result of the AmnioSense™ was compared with the clinical diagnosis, which was based on sterile speculum examination.
The TPL accurately detected 58 of the 59 subjects found to have amniotic fluid leakage by the speculum examination; thus, the sensitivity of the TPL was 98%. When comparing the AmnioSense™ performance to speculum examination (low sensitivity methods), the specificity was 65%, as the TPL demonstrated a negative result for 52 of the 80 subjects whose speculum examination diagnosis was negative for amniotic fluid leakage.
References: 1 Effectiveness of a novel home-based testing device for the detection of rupture of membranes. Bornstein J, Ohel G, Sorokin Y, Reape KZ, Shnaider O, Kessary-Shoham H, Ophir E. Am J Perinatol. 2009 Jan;26(1):45-50. 2 Nonintrusive diagnosis of premature ruptured amniotic membranes using a novel polymer. Bornstein J, Geva A, Solt I, Fait V, Schoenfeld A, Shoham HK, Sobel J. Am J Perinatol. 2006 Aug;23(6):351-4. 3 Prospective cohort study investigating the reliability of the AmnioSense method for detection of spontaneous rupture of membranes. Mulhair L, Carter J, Poston L, Seed P, Briley A. BJOG. 2009 Jan;116(2):313-8.