AL-SENSE™ – Amniotic Fluid Detection Kit

The AL-SENSE™ Amniotic fluid detection kit is an in vitro self-test that allows detection of possible amniotic fluid leakage in the event of pregnant women sensing unidentified vaginal wetness. AL-SENSE™ can distinguish between amniotic fluid leak (positive result) and urine (negative result). It is easy to use and results reading is clear Yes/No with no need for color scale. Home use and professional use.

  • Non-invasive
  • AL-SENSE™ is the only amniotic fluid test available as a home self test
  • Distinct color change – Positive/Negative. Result interpretation doesn’t require a color scale
  • One step test – Results can be interpreted within 15 minutes of wetness
  • Detects even minimal amounts of Amniotic leaks
  • Clearly distinguishes between amniotic leakage and urine
  • Allows for continuous monitoring of leaks including intermediate leaks
  • Significant cost saving
Performance Highlights
Sensitivity 97.06%
Specificity 96.92%
PPV 96.12%
NPV 97.67%

Advantages of prolonged monitoring
Amniotic Fluid Leakage may have a very small volume and may be “missed” in examinations which are considered momentary examination.

The ability of AL-SENSE™ to detect even small volume of amniotic fluid, over a prolonged period of time, may assist in avoiding mis-diagnosis of amniotic fluid leakage and sending woman with amniotic fluid leakage home. AL-SENSE™ samples continuously, reacting to minute leak, features not offered by any other product for hospital or home use.

Who are the intended users?

Gynecologist’s clinics or Delivery rooms
For amniotic fluid leakage screening or verification, especially for discontinuous leakage.

Pregnant women at home
Distinguishes between amniotic fluid leakage and urine leak.

  • Daily monitoring of high risk pregnancies such as women being monitored for early contractions and past miscarriages.
  • Daily monitoring of GBS patients Who are at risk of infecting their fetus with GBS when their amniotic fluid is leaking.
  • Pregnant patients arriving the ER and complaining of wetness optimizing the hospitals resources, saving doctors’ and nurses’ time and avoiding use of expensive tests by screening with the AL-SENSE™.
Amniotic Fluid

Amniotic fluid is the fluid surrounding the fetus. It has vital part in the fetal normal development: it protects the fetus from trauma, protects the umbilical cord from pressure and is a source for fluids and nutrition to the fetus. The amniotic fluid also supplies the fetus an environment for development and allows developing the lungs and promotes muscular/skeletal development. It also acts as anti inflammatory substance.

Premature Rupture of Membranes (PROM)

Premature rupture of membranes (PROM) refers to membrane rupture before the onset of uterine contractions; preterm PROM (PPROM) is the term used when the pregnancy is less than 37 completed weeks of gestation.
Occurs in 15% of pregnancies.

Amniotic fluid leakage complications:

  • Llack of fluid (oligohydramnios)
  • Infections (fetus and mother)
  • Umbilical cord prolapse
  • Premature placental separation
  • Bleeding and premature labor

Those complications may cause fetal morbidity and even mortality

Patients who do not go into labor within 24 hours after the occurrence of PROM are at increasing risk of infection as the duration of rupture increases. Chorioamnionitis, endometritis, sepsis, and neonatal infections.

Urine leakage during pregnancy

30-40 % of women experience some degree of urinary leakage during pregnancy.
Kristiansson P, Samuelsson E, von Schoultz B, Svärdsudd K. Reproductive hormones and stress urinary incontinence in pregnancy. Acta Obstet Gynecol Scand. 2001 Dec;80(12):1125-30.

Amniotic Fluid Leak – major stress to pregnant women

  • Women who feel wetness which is due to amniotic leak may interpret it as urine and avoid visiting the hospital. This may cause great harm to both mother and baby.
  • Over 20% of pregnant women report to hospital because of wetness. 50% are sent home as the wetness was due to urine .
  • Feeling of wetness is common and repeating situation during pregnancy

FDA (510)K approval pending

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Outside United States