[Clinical usefulness of the ROMCheck Membrane Immunoassay--a new method for the demonstration of the rupture of fetal membranes].

An investigation of the clinical usefulness of ROMCheck Membrane Immunoassay, a new method for the detection of amniotic fluid in the vagina, was undertaken. The ROMCheck-test is a monoclonal antibody test against fetal fibronectin in amniotic fluid. It was compared to commonly used methods as ferning, Nile blue staining of fetal cells and Nitrazine paper. We examined twenty pregnant women with suspected rupture of membranes and twenty women with apparently intact membranes receiving routine prenatal care. We found that clinical detection of amniotic fluid in the vagina resulted in a positive ROMCheck-test. When the ROMCheck-test was negative there was no indication of rupture of membranes. When the ROMCheck-test was positive and the other tests were negative, we could not exclude the possibility of the presence of amniotic fluid in the vagina at the time of examination. The test is a useful tool in identifying the presence or absence of amniotic fluid in the vagina.