Fetal lung maturity test
AssigneeThe University of North Carolina at Chapel Hill
InventorsBernard E. Statland, Geoffrey Sher
Life of this patent
Estimating the term…
Abstract
A simple rapid STAT test and test kit are provided for the reliable determination of prenatal lung maturity as well as other surfactant lipid dependent determinations. The method involves a shake test employing a plurality of vials having graduated volumes of ethanol, including a dye, normally in combination with a positive control. A predetermined amount of the sample is introduced into each of the vials, the vials shaken in a reproducible manner, and the highest ethanol volume fraction which provides for a stable foam determined. Based on statistical evaluations, an ethanol volume fraction above 0.45 will generally be regarded as positive, meaning healthy lung maturity, while a value below about 0.45 will generally indicate that further investigation is warranted.
Claims6
A method for measuring fetal or neonatal lung maturity employing amniotic fluid comprising:
- combining a predetermined volume of amniotic fluid with graduated amounts of 95% aqueous ethanol to 100% ethanol to provide at least six mixtures of graduated ethanol volume fractions from 0.45 to 0.50 to 0.01 graduations;
- agitating each of the mixtures in substantially the same manner;
- and
- determining the highest ethanol volume fraction which results in a persistent foam at the interface;
- wherein an ethanol volume fraction of greater than 0.45 with persistent foam indicates fetal lung maturity.
Dependencies are inferred from the claim text.