The PartoSure Test is a rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of placental alpha microglobulin-1 (PAMG-1) in vaginal secretions of pregnant women. The device is designed as an aid to rapidly assess the risk of preterm delivery in ≤7 or ≤14 days from the time of cervicovaginal sample collection in pregnant women with signs and symptoms of early preterm labor, intact amniotic membranes and minimal cervical dilatation (≤ 3 cm), sampled between 20 weeks, 0 days and 36 weeks, 6 days gestation.
