The AmniSure® Rupture of Membranes (ROM) Test assists clinicians in diagnosing ROM as a rapid and accurate point-of-care test. This article provides NHS healthcare professionals with guidance on when and how to use the AmniSure® test in clinical practice.
Why do Clinicians use AmniSure®?
AmniSure® is recommended for use in NICE NG25, RCOG Green-Top 73, and European Guidelines as a biomarker (PAMG-1) diagnostic tool for PROM. Traditional methods for diagnosing ROM, such as speculum examination, nitrazine testing, and ferning tests, can be subjective and occasionally inconclusive. Using clinical examination alone, studies have found that clinicians may be uncertain on ROM diagnosis in 47% of cases 1.
AmniSure® is a rapid immunoassay that detects placental alpha microglobulin-1 (PAMG-1), a well-researched biomarker highly concentrated in amniotic fluid. AmniSure® has been evaluated in more than 20 peer reviewed clinical studies and has a sensitivity of 98.9% and specificity of 100% 2. It remains the only point-of-care ROM test to achieve a 99% correlation with the gold standard of ROM testing - the indigo-carmine injection 3.
When to Use AmniSure®
Universally, it is recommended in NICE NG25, RCOG Green-Top 73, and European Guidelines to use AmniSure® in cases of uncertainty where no visible leakage of fluid can be observed.
AmniSure® can be used at any gestation, and with trace amounts of blood.
How to Use AmniSure®
The test is simple to perform at bedside and involves the following steps:
Insert the sterile swab into the vaginal canal (approximately 5-7 cm) for 1 minute.
Place the swab into the provided vial containing solvent and rotate the swab for 1 minute.
Remove the swab and insert the white end of the test strip into the vial. Remove the test strip if two lines are clearly visible in the vial, or after 5 minutes. Avoid reading results after more than 10 minutes have passed since dipping the strip into the vial.
Place the strip on a dry, flat surface and read the result.
Two lines indicates a positive result, while a single control line indicates a negative result.
Interpreting and Acting on Results
Positive Result: Formulate a care plan based on the patient's full clinical picture.
Negative Result: Consider discharge alongside clinical judgement.
Invalid Result: Repeat the test.
Note: Any line whether faint or clear on the test line means the outcome is positive, the control line should always appear and if it doesn’t it means the test is invalid and needs to be re-taken.
For further guidance on integrating AmniSure® into your clinical practice, refer to your local trust guidelines or contact AGHealth for training and support here. References
Neil and Wallace (2010) – Is AmniSure® useful in the management of women with prelabour rupture of the membranes? Australian and New Zealand Journal of Obstetrics and Gynaecology 2010; 50: 534–538
Cousins, L.M. et al. (2005) AmniSure® placental alpha microglobulin-1 rapid immunoassay versus standard diagnostic methods for detection of rupture of membranes. Am. J. Perinatol. 22, 317–20.
Sosa, C.G. et al. (2014) – Comparison of placental alpha microglobulin-1 in vaginal fluid with intra-amniotic injection of indigo carmine for the diagnosis of rupture of membranes. DOI 10.1515/jpm-2013-0245 J. Perinat. Med. 2014; 42(5): 611–616.
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