Endotoxin testing assay and method of same
AssigneeBoard of Regents, The University of Texas System
InventorsJing Yong Ye, Jonathan D. Scudder
Life of this patent
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Abstract
A pyrogenicity test method and assay of endotoxins allows for rapid and ultrahigh sensitivity testing of parenteral pharmaceuticals or medical devices that contact blood or cerebrospinal fluid by employing a Limulus Amoebocyte Lysate (LAL) assay monitored with a photonic-crystal biosensor. The photonic-crystal biosensor is capable of determining the presence of endotoxins in a test sample by detecting shifts in the resonant condition of an open microcavity affected by the changes in the refractive index of the analyte solutions used.
Claims14
A Limulus Amoebocyte Lysate (LAL) endotoxin assay system comprising an open cavity photonic crystal total internal reflection (PC-TIR) biosensor, the PC-TIR biosensor further comprising a prism, a substrate, at least one dielectric layer on the substrate, at least one analyte well on the at least one dielectric layer, the substrate being coupled to the prism, the endotoxin assay system configured to detect endotoxin in an analyte in the at least one analyte well by monitoring changes in a refractive index of the analyte.
An endotoxin assay method comprising the steps of providing an analyte sample suspected of containing an endotoxin from lipopolysaccharide cell wall component of Gram-negative bacteria in an analyte;
- adding the analyte sample to at least one sample well optically coupled to and interfacing with a reflecting surface of a total internal reflection open cavity photonic crystal biosensor optically coupled to an optical prism;
- adding Limulus Amoebocyte Lysate (LAL) reagent to the analyte sample;
- exposing the analyte sample in the at least one sample well to a focused probe laser signal across the total internal reflection open cavity photonic crystal biosensor;
- reflecting an output beam from the photonic crystal biosensor through the optical prism;
- imaging the output beam;
- and monitoring changes in a refractive index of the analyte sample.
Dependencies are inferred from the claim text.