Is fluorescence polarization reliable and cost efficient in a fetal lung maturity cascade?
OBJECTIVE: The objective of the study was to compare the accuracy of the TDxFLM test (Abbott Laboratories) with the fetal lung maturity cascade (shake, foam stability index, lecithin/sphingomyelin tests) and to determine whether the TDxFLM test could increase the efficiency and reduce the cost without decreasing the reliability of a cascade. STUDY DESIGN: A prospective, single-blinded study was conducted. Uncontaminated amniotic fluid obtained by transabdominal amniocentesis for fetal lung maturity assessment was evaluated with use of the fetal lung maturity cascade and the TDxFLM test. At study completion the results of the TDxFLM test were compared with those of the maturity cascade with regard to hyaline membrane disease, which was defined by strict clinical and radiographic parameters. A power analysis was performed requiring a sample size of 100 infants delivered within 72 hours of amniocentesis with use of the 95% confidence interval. RESULTS: A total of 115 cases had a full matu