Clinical implementation of a rapid, automated assay for assessing fetal lung maturity

We retrospectively determined cutoff levels and implemented the use of the TDxFLx assay in assessing the likelihood or absence of respiratory distress syndrome or fetal lung maturity (FLM) in a high-risk obstetric setting when compared to the lecithin/sphingomyelin (L/S) ratio and disaturated lecithin (DSL) measurements. Using a mature TDxFLx cutoff value of > or = 50 mg/g and an immature cutoff value of < 20 mg/g, 88% of L/S ratio and DSL measurements could be eliminated without compromise to the patient. The > or = 50 mg/g TDxFLx cutoff value resulted in a sensitivity of 100% and specificity of 88%. We also recommend the use of the TDxFLx assay as a screening test in diabetic pregnancies. More timely patient care occurred when the rapid TDxFLx assay was implemented by the laboratory and used by clinicians.