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Clinical utility /Significance The AmniSure Fetal Membranes Rupture Test is for the detection of human amniotic fluid PAMG-1 protein in vaginal discharge of pregnant woman. The test should be used to evaluate patients with suspicion of and/or clinical signs/symptoms suggestive of fetal membranes rupture. The AmniSure® ROM (Rupture Of [fetal] Membranes) Test is a rapid, non-instrumented qualitative immunochromatographic test for the in-vitro detection of amniotic fluid in the vaginal discharge of pregnant women. The test is for use by health care professionals to aid in the detection of fetal membranes rupture in pregnant women with a suspicion of such a rupture.   Analytical principle Sample of amniotic fluid (taken by vaginal swab) is placed into a vial with solvent. Solvent extracts the sample from the swab for one minute, after which the swab is discarded. AmniSure® Test Strip (a lateral flow device) is then inserted into the vial. The sample substance flows from the Pad Region of the Test Strip to the Test Region. The test result is read visually by the presence of one or two lines.   Special safety precautions Routine Practices” as directed by Health Canada, must be considered as the level of care provided for all patients. Use Health Canada Guidelines for “Routine Practices” to avoid exposure to blood, body fluids and contaminated surfaces. All patient samples, as well as the materials they contact, are to be considered biohazardous and therefore capable of transmitting infection or cross contamination. Gloves must be used as per the MUHC Policy Routine Precautions for Inpatient Settings