In vitro process for detecting endotoxin in a biological fluid
First Claim
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1. 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.
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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.
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8 Claims
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1. An in vitro process for determining the presence or absence of endotoxin in a biological fluid, said process comprising:
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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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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Specification