Clinical evaluation of the NBD-PC fluorescence polarization assay for prediction of fetal lung maturity.

Objectives: 1) To examine a fluorescence polarization (FP) assay with an independent set of data that contained more cases of respiratory distress syndrome (RDS) than a previous study, 2) to determine whether the same reference ranges are applicable to infants born to diabetic women, and 3) to evaluate whether adding the lecithin-sphingomyelin ratio (L/S) would substantially improve the prediction of RDS among women with an intermediate FP value (between 0.26-0.289).
Methods: We identified 389 women who had FP analysis performed at the University of Washington Medical Center from February 1986 to October 1988 and who delivered within 3 days of amniocentesis. We reviewed the medical records of these women and their infants to extract information for our study.
Results: For FP values of 0.26 or greater, the sensitivity and specificity for prediction of RDS were 90.2 and 84.6%, respectively, compared with 100 and 82.0% in the previous study. For FP values of 0.29 or greater, the sensitivity and specificity were 62.8 and 94.2%, respectively (80.8 and 96.2% in the previous study). Among diabetics, an FP result below 0.26 was associated with the same low risk of RDS as among non-diabetics. Among the patients with FP between 0.26-0.289, the addition of L/S did not provide a clinically useful improvement in the prediction of fetal lung maturity.
Conclusion: The NBD-PC FP assay can be used as the sole test of fetal lung maturity in most clinical circumstances.