In vitro process for detecting endotoxin in a biological fluid
AssigneePreventive Systems, Inc.
InventorsNick S. Harris, Robert Feinstein
Life of this patent
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Abstract
An in vitro process for detecting the presence of endotoxin in a biological fluid such as a parenteral fluid, whole blood, and the like, wherein amebocyte lysate from the hemolymph of the horseshoe crab, Limulus polyphemus, is intimately contacted with and incubated in the presence of a synthetic plastic polymer capable of adsorbing endotoxin which has previously been contacted with the biological fluid. The presence or absence of a gelation reaction in the amebocyte lysate is then observed. The presence of a gelation reaction determines the presence of endotoxin in the biological fluid.
Claims8
An in vitro process for determining the presence or absence of endotoxin in a biological fluid, said process comprising:
- a. contacting said biological fluid with a non-ionogenic, hydrophobic, non-polar, aliphatic, synthetic plastic polymer whereby endotoxin present in the fluid is adsorbed by the synthetic plastic polymer;
- b. removing said synthetic plastic polymer from contact with the biological fluid;
- c. contacting the plastic polymer of (b) with amebocyte lysate from the hemolymph of the horseshoe crab, Limulus polyphemus;
- d. incubating the amebocyte lysate in contact with the synthetic plastic polymer of (c);
- and
- e. observing the presence or absence of gelation reaction in the amebocyte lysate.
Dependencies are inferred from the claim text.