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The Actim PROM test is a visually interpreted, qualitative immunoassay rapid test for the detection of amniotic fluid in cervicovaginal secretions during pregnancy. The Actim PROM test detects IGFBP-1, a major protein in amniotic fluid and a marker of the presence of amniotic fluid in a vaginal sample. The test is intended for prescription use in point of care and clinical laboratory settings to help diagnose the rupture of fetal membranes (ROM) in pregnant women ≥29 weeks gestation who present with signs, symptoms or complaints suggestive of ROM.

The Actim PROM test is a rapid test to aid in diagnosis of premature rupture of fetal membranes in pregnant women who present with signs, symptoms or complaints suggestive of RQM. The test is based on lateral flow immunoassay. It utilizes two monoclonal antibodies to human IGFBP-1. One of the two antibodies is bound to blue latex particles (detecting antibody). The other antibody is immobilized as a test line on the membrane (catching antibody). The test strip (dipstick) is composed of the sample/conjugate pad, the membrane with test and control lines, and the absorbent pad assembled between plastic films. The upper film contains a test window. When the sample area of the dipstick is placed in an extracted sample, the dipstick absorbs liquid, which starts to flow up the dipstick. If the sample contains IGFBP-1 it binds to the antibody labeled with latex particles. The particles are carried by the liquid flow, and if IGFBP-1 is bound to them, they bind to the catching antibody. A blue line (test line) will appear in the result area if the concentration of IGFBP-1 in the sample exceeds the detection limit of the test. A second blue line, the control line, confirms correct operator performance of the test.

The Actim PROM test is a visually interpreted, qualitative immunochromatographic rapid test for the detection of amniotic fluid in cervicovaginal secretions during pregnancy. Actim PROM test detects IGFBP-1, which is a major protein in amniotic fluid and a marker of the presence of amniotic fluid in a cervicovaginal sample. The test is intended for professional use to help diagnose the rupture of fetal membranes (ROM) in pregnant women at >34 weeks gestation when patients report signs, symptoms or complaints suggestive of ROM or if such signs are otherwise observed. The Actim PROM Controls are intended for use as external controls with the Actim PROM test. The controls may also be used to demonstrate negative results and weak and strong positive results.

The Actim PROM is a rapid test for detection of premature rupture of fetal membranes. The test principle is lateral flow immunochromatography. Actim PROM is available in packages of 3, 10 and 20 tests. Each individual test pack contains a sterile polyester swab, specimen extraction solution and a dipstick. The dipstick is packed in a foil pouch with desiccant. The Actim PROM Controls contain one vial each of negative, low positive and high positive controls, and reconstitution solution.