Lateral Flow Technology
The AmniSure ROM Test is a one-step immunochromatographic assay. It detects trace amounts of PAMG-1, a protein found in amniotic fluid that appears in vaginal discharge after fetal membranes rupture. Monoclonal antibodies are used to detect the protein.
The AmniSure ROM Test works within a wide range of PAMG-1 concentrations potentially found in vaginal discharge (from 5 ng/ml to 200 µg/ml). The diagnostic accuracy of the test allows it to detect even a minuscule amount of released amniotic fluid. With intact fetal membranes, the test does not normally detect PAMG-1 due to its low background concentration.
"The black dots represent the PAMG-1 protein from amniotic fluid. Located on the test strip are the A-Antibodies (the little blue Y's) that have a small red circle representing dye attached. Along the test region there are immobilized B-Antibodies (the upside down Ys). Above this is the control region which indicates the internal control. The black dots representing PAMG-1 will flow up the strip and attach to the A-Antibodies as you can see in the pad region. These coupled Antibodies will flow up the test strip and attach to the B-Antibodies (the upside down Ys). The dye attached to them will, in turn, color the test region, causing a red line to appear. The AmniSure control line will also be visible indicating that the test is working. This internal control covers all analytic components of the test"