Evaluation of a Novel Diagnostic Kit for the Detection of Placental Alpha-Microglobulin-1 in the Prediction of Preterm Birth

The novel kit for the detection of PAMG-1 is a diagnostic device employing monoclonal antibodies that detect Placental α1 Microglobulin present in cervico-vaginal secretions manufactured by AmniSure® International, LLC, Boston, MA. The in vivo sensitivity detection threshold is 4ng/ml. During the test procedure, PAMG-1 from the sample sequentially binds to monoclonal antibody conjugated with labeled particles, then to monoclonal antibody immobilized on an insoluble carrier. The test requires a 30 second swab saturation in the vagina (a sterile speculum examination is not required), a 30 second active washing step whereby the swab just removed from the vagina is actively rotated in a solvent filled vial and lastly, a 5 minute waiting period from the time the swab is removed and the test strip is inserted if two testing lines do not appear sooner.