Multistep immunoassay kits for the diagnosis of rupture of membranes are relatively complex and are not designed to be used by pregnant women themselves.

Current Prepartal women is usually at home provided the amniotic fluid reagent paper for oneself, i. It was evaluated by the UK National Institute for Health and Care Excellence (NICE) as part of the Medical Technologies Evaluation Programme. The studies show that there are several potential applications for AminoSense, including using it in triage, to identify ‘leaks’ which are caused by urinary incontinence or an increase in harmless vaginal secretion, and to reserve speculum examination only for those women who have a positive result using the AmnioSense test. The absorbent device changes color if it comes into contact with a fluid characterized by a pH value greater than or equal to 6.

The EAC conducted a more detailed sensitivity, threshold and impact analysis and determined that the cost savings were most sensitive to the midwife time for a CTG trace, followed by the time to administer a Vision ALD test and the proportion of patients with a negative Vision ALD test result. The Committee heard advice from clinical experts indicating that in the community setting Vision ALD would most likely be administered by a practice-based or community midwife, followed by a speculum examination in an ADU for positive results. In their submission the sponsor stated that the speculum examination has a low sensitivity and quoted false negative rates of 12–30 %. The panty-liner was then reviewed for 10 minutes, for any colour change to stabilise, before being checked by a midwife, who recorded the results. will indicate no to little detection of amniotic fluids, while a higher pH will signal higher levels of amniotic fluids.

However, by implementing Vision ALD in the same setting as current standard diagnosis the savings from avoided referrals did not outweigh the cost of additional Vision ALD tests.Cedar a collaboration between Cardiff and Vale University Health Board and Cardiff University, was the EAC commissioned by NICE to produce the assessment report for this technology. Cost savings were only realisable if the care pathway was altered so that the initial testing could be conducted by a lower cost healthcare professional. The panty-liner is worn until wet or for up to 12 h and the indicator strip is removed and placed in a plastic drying box for 30 min. Therefore, costs were either saved or incurred solely due to the diagnostic tests themselves, or the healthcare setting/clinician time used to administer them.