Multicenter evaluation of TDx test for assessing fetal lung maturity.

Abstract:

:"TDx Fetal Lung Maturity," an automated assay that measures the relative concentrations of surfactant and albumin in amniotic fluid, was compared with the lecithin/sphingomyelin (L/S) ratio and phosphatidylglycerol determination at five clinical sites. A total of 695 amniotic fluid samples were analyzed, of which 312 were followed by delivery of the infant within three days of sample collection. Of these 312, 24 developed respiratory distress syndrome and seven developed transient tachypnea. With the cutoff for maturity set at a surfactant/albumin value of 50 mg/g, the assay showed a sensitivity of 0.96 and a specificity of 0.88 for all samples, compared with a sensitivity of 0.96 and a specificity of 0.83 for the L/S ratio. The combination of rapid assay (30 min), accurate results, and uniformity among testing centers makes the TDx assay a very promising method.

journal_name

Clin Chem

journal_title

Clinical chemistry

authors

Russell JC,Cooper CM,Ketchum CH,Torday JS,Richardson DK,Holt JA,Kaplan LA,Swanson JR,Ivie WM

subject

Has Abstract

pub_date

1989-06-01 00:00:00

pages

1005-10

issue

6

eissn

0009-9147

issn

1530-8561

journal_volume

35

pub_type

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