This is in accordance with the NICE scope in which identification of infections is an outcome measure.

women with equivocal ROM on speculum examination) was subtly different to that in the scope for Vision ALD and therefore their results required re-interpretation rather than quoting. The EAC recalculations show that Vision ALD has high sensitivity and reasonably high specificity and therefore shows promise in terms of non-inferiority to the reference standard. The sponsor (CommonSense Ltd) identified five studies, of which three were deemed within scope by the External Assessment Centre (EAC). Infected vaginal discharge does not contain high levels of ammonia so the colour change will remain after 30 min.

Few responses were received and only one comment from the sponsor resulted in a minor change to Recommendation 1. The population of interest was pregnant women with unidentified vaginal wetness which may be leaking amniotic fluid caused by ruptured membranes. The sponsor provided an evidence submission to NICE that reviewed the clinical and cost evidence for Vision ALD and presented a de novo cost-consequences model.

In the case of Vision ALD, nearly half of women presenting with unexplained vaginal wetness could avoid an unnecessary speculum examination, which some women may find uncomfortable or embarrassing. Additionally, as many as 30–40% of pregnant women experience urinary leakage at the end of pregnancy. MTG15 Scope: Vision Amniotic Leak Detector to eliminate amnitiotic fluid leakage as a cause of vaginal wetness in pregnancy. What sets it apart is its accuracy and specificity, ensuring that it won’t give false positive results due to urine contamination.If your caregiver thinks you're leaking amniotic fluid but all the other tests are inconclusive, she may inject blue dye into the amniotic sac and have you wear a sanitary pad. The Committee concluded that a change in practice to avoid secondary care referrals would be acceptable to clinicians in the care pathway, and that Vision ALD would allow patients to avoid inconvenient, invasive and unnecessary speculum examinations. While these tests are low risk and non-invasive, it’s vital they are performed in a professional setting to establish safety and viability.