Abstract
Objective: To validate the reliability and stability of the AL-SENSE panty-liner for detection of amniotic fluid in the second trimester. Study design: Amniotic fluid drawn during amniocentesis between 16 to 23 weeks of gestation was used for the study.100 µl and 400 µl of amniotic fluid, were dripped onto two panty liners, respectively. After 5 minutes the indicator strip was removed from the AL-SENSE, dried and examined. The color was recorded at time 0 and 5 minutes, and then every 10 minutes for the first 30 minutes, then at 1, 2, 6 and 12 hours. Results: 50 women were enrolled and 49 completed the study. 100% of both volume samples changed color from yellow to blue during the first 5 minutes and remained stable after twelve hours of follow-up. In the 100 μl subgroup, seven of the 49 samples (14.3%) had a delayed color change and in the 400 μl subgroup one of 49 (2.04%) had a delay in change of color. Conclusion: Amniotic fluid drawn during amniocentesis at weeks 16 - 23 of gestation have a positive, stable staining effect on the AL-SENSE panty liner. Hence, AL-SENSE may be reliable for detection of amniotic fluid leakage during the second trimester.
Highlights
A diagnostic panty-liner kit—“AL-SENSE”® (Commonsense, Caesarea, Israel) was developed to detect amniotic fluid leak
Study design: Amniotic fluid drawn during amniocentesis between 16 to 23 weeks of gestation was used for the study.100 μl and 400 μl of amniotic fluid, were dripped onto two panty liners, respectively
Amniotic fluid drawn during amniocentesis at weeks 16 - 23 of gestation have a positive, stable staining effect on the AL-SENSE panty liner
Summary
A diagnostic panty-liner kit—“AL-SENSE”® (Commonsense, Caesarea, Israel) was developed to detect amniotic fluid leak. In previous third trimester clinical studies [1,2], the AL-SENSE panty-liner test was documented as a sensitive tool for diagnosing premature rupture of the membranes (PROM) and differentiating amniotic fluid leaks from urinary incontinence. The panty-liner was compared to a series of conventional tests such as speculum examination, nitrazine test, microscopic evaluation for ferning and ultrasound determination of intra-uterine amniotic volume [2]. These results were confirmed by another study [3] comparing the panty-liner test to speculum examination for detection of ruptured membranes; it found 98% sensitivity and 65% specificity
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