Pregnancy test 500170

IGFBP-1serumvaginal secretions

The StrongStep® PROM test is a visually interpreted, qualitative immunochromatographic test for detection of IGFBP-1 from amniotic fluid in vaginal secretions during pregnancy. The test is intended for professional use to help diagnose the rupture of fetal membranes (ROM) in pregnant women. INTRODUCTION The concentration of IGFBP-1 (insulin-like growth factor binding protein-1) in amniotic fluid is 100 to 1000 times higher than in maternal serum. IGFBP-1 is not usually present in the vagina, but after rupture of fetal membranes, amniotic fluid with a high concentration of IGFBP-1 mixes with vaginal secretions. In StrongStep® PROM test, a specimen of vaginal secretion is taken with a sterile polyester swab and the specimen is extracted into Specimen Extraction Solution. The presence of IGFBP-1 in the solution is detected using a rapid test device. PRINCIPLE The StrongStep® PROM Test uses color immunochromatographic, capillary flow technology. The test procedure requires the solubilization of IGFBP-1 from a vaginal swab by mixing the swab in Sample Buffer. Then the mixed sample buffer is added to the test cassette sample well and the mixture migrates along the membrane surface. If IGFBP-1 is present in the sample, it will form a complex with the primary anti- IGFBP-1 antibody conjugated to colored particles. The complex will then be bound by a second anti- IGFBP-1 antibody coated on the nitrocellulose membrane. The appearance of a visible test line along with the control line will indicate a positive result. KIT COMPONENTS 20 Individually packed test devices Each device contains a strip with colored conjugates