Assessment of the AmnioStat-FLM immunoagglutination test for phosphatidylglycerol in amniotic fluid.
One hundred and eight amniotic fluids were assayed by the AmnioStat-FLM (A-FLM) immunological agglutination test for phosphatidylglycerol (PG) and simultaneously measured enzymatically for PG content. Of 52 amniotic fluids found to be PG negative by the A-FLM method, all had enzymatic PG concentrations less than or equal to 1.5 mumol/l. Conversely, of 56 amniotic fluids judged to be either PG positive or weak positive, all but five had enzymatic PG concentrations greater than 1.5 mumol/l. The sensitivity of the A-FLM assay employed clinically for predicting foetal lung maturity was 89% and the specificity was 100%. The overall predictive accuracy of the test could be improved by providing controls at lower, more appropriate PG concentrations. Ninety-one fluids analysed by the A-FLM kit were subsequently tested for the presence of PG by two-dimensional thin-layer chromatography (2D TLC). A 94%-concordance between the methods was found.