NICE (National Institute for Health and Care Excellence)

Clinical research on AmnioSense™ (which includes alternative names: Vision ALD™,
AL-SENSE™, AmniScreen™) was considered by the National Institute for Clinical Evidence
(NICE) for its review on the guidance: Vision Amniotic Leak Detector to assess unexplained
vaginal wetness in pregnancy.1

  • The Committee considered that the studies described (in the review) indicate that AmnioSense™ is sufficiently accurate to reliably exclude amniotic fluid leak as a cause of vaginal wetness in pregnancy.
  • The Committee considered that the use of AmnioSense™ would avoid unnecessary speculum examinations, which may be intrusive and uncomfortable.
  • The Committee concluded that the AmnioSense™ test is sufficiently accurate to exclude amniotic fluid leak as a cause of wetness in pregnancy and that its use in the correct clinical setting would avoid unneccessary speculum examinations.
  • The Committee considered that the use of AmnioSense™ in the community could generate cost savings and avoid the discomfort and inconvenience of unnecessary speculum examinations in some pregnant women.
  • The Committee concluded that the adoption of AmnioSense™, with appropriate changes to clinical practice in the community, should be encouraged.

1 NICE report; Vision Amniotic Leak Detector to assess unexplained vaginal wetness in pregnancy, Medical technologies guidance [MTG15] July 2013

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