Fetal lung maturity test

Chemistry: physical processes – Physical processes – Crystallization

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73 601, 422 61, G01N 3348, G01N 1300

Patent

active

042330327

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.

REFERENCES:
J. A. Clements et al., New England Journal of Medicine, 286 (20), 1077-1081 (1972).
"Nonionic Surfactants", Martin J. Schick, ed., 505, Marcel Dekker, Inc., New York, 1967.
J. Edwards and P. Baillie, S. Afr. Med. J., 47, 2070-2073 (1973).
Geoffrey Sher, Bernard E. Statland and Dennis E. Freer, Abstract entitled "The Use of Graded Ethanol Volume Fractions in Assessing the Functionality of Surfactant in Amniotic Fluid", presented annual meeting of the Society of Gynecological Investigation; Atlanta, Georgia, Mar. 15-18, 1978.

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