Amniostat-FLM: An initial clinical trial with both vaginal pool and amniocentesis samples

Abstract

Amniostat-FLM, a new rapid slide agglutination test, was compared with thin-layer chromatography as a method for detecting phosphatidylglycerol in amniotic fluid. This is the first reported use of Amniostat-FLM to evaluate vaginal pool and contaminated vaginal pool amniotic fluid. One hundred one of 161 amniotic fluid samples were collected from the vaginal pool. Thirty-nine of these were contaminated. Vaginal pool amniotic fluid, whether contaminated or not, did not adversely effect the ease of performance, reliability, or interpretation of Amniostat-FLM. This test seems ideally suited to institutions where 24-hour availability of thin-layer chromatography is not available. In institutions where it is available, Amniostat-FLM could be used as a screening test. Amniostat-FLM was found to be significantly less sensitive when compared with thin-layer chromatography in detecting the presence of phosphatidylglycerol. At our institution the screening of amniotic fluid samples with Amniostat-FLM before use of thin-layer chromatography was only cost effective at ≥ 34 weeks of gestation.