The PROM Rapid Test is a rapid qualitative immunochromatographic test for the detection of IGFBP-1 in vaginal secretions. The test is intended for use by health care professionals as an aid in the diagnosis of premature rupture of amniotic membranes (prom) in pregnant women where prom is suspected.
Premature rupture of the amniotic membranes (PROM) affects 5 to 10% of pregnancies and is associated with serious complications, including premature delivery and neonatal sepsis. Rapid and accurate diagnosis is essential to allow appropriate obstetric intervention. Conversely a false diagnosis of prom may result in unnecessary intervention including hospitalization and induction of labour.
 
PROM Rapid Test is an immunochromatographic test for IGFBP-1 in pregnant women. The test uses murine monoclonal antibodies that specifically bind to IGFBP-1. Secretions sampled with a vaginal swab are extracted into a vial of extraction buffer. A dipstick is vertically introduced into the vial and the test sample is absorbed into the conjugate pad. This pad contains the first monoclonal antibody (conjugated to gold particles) which binds to any IGFBP-1 present. The resulting antibody-IGFBP-1 complex migrates along the dipstick membrane by capillary attraction to the test line where the immobilized second monoclonal antibody captures the complex by binding to IGFBP-1. This results in a red test line if IGFBP-1 is present in the sample. The control line contains goat anti-mouse IgG which will bind to the first anti-IGFBP-1 monoclonal antibody whether IGFBP-1 is present in the sample or not. Binding creates a red control line that verifies the test is functioning properly.