Limulus amoebocyte lysate 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 assay and method of pyrogen testing that 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 utilizing a photonic-crystal biosensor. The photonic-crystal biosensor is capable of determining the presence of endotoxins in a test sample by monitoring shifts in the resonant wavelength of an open microcavity affected by the changes in the refractive index of the analyte solutions used.
Claims8
A Limulus Amoebocyte Lysate (LAL) assay system comprising a photonic crystal total internal reflection (PC-TIR) biosensor that measures endotoxins in an analyte by monitoring changes in a refractive index of the analyte, wherein the PC-TIR biosensor has a plurality of microchannels on a surface thereof;
- and
- a laser light source providing a laser light beam;
- a polarizer positioned to receive the laser light beam from the laser light source;
- a spatial filter configured to receive a polarized laser light beam from the polarizer and expand the polarized laser light beam;
- a plurality of mirrors configured to direct the expanded polarized laser light beam toward the PC-TIR biosensor;
- a lens configured to focus the expanded polarized laser light beam into a line crossing at least one of the plurality of microchannels on the surface of the PC-TIR biosensor;
- a collimating lens positioned to receive a reflected laser light beam from the surface of the PC-TIR biosensor;
- and
- an imaging device capable of imaging the collimated reflected laser light beam to create an image, the image having a plurality of sections corresponding to a resonant angle of the laser light beam.
A Limulus Amoebocyte Lysate (LAL) assay method wherein a refractive index of an analyte suspected of containing an endotoxin is measured, comprising the steps of:
- a. Placing the analyte in an evanescent field of a photonic crystal biosensor having an open cavity and total internal reflection and a plurality of microchannels on a surface thereof;
- b. Providing a source of polarized laser light directed to the photonic crystal biosensor, expanding the polarized laser light and focusing the expanded polarized light into a line;
- c. Passing the line of laser light through the analyte and crossing at least one of the plurality of microchannels on the surface of the photonic crystal biosensor;
- d. Imaging reflected laser light, the image having a plurality of sections corresponding to a resonant angle of the laser light beam;
- and
- e. Measuring changes in the refractive index of the analyte suspected of containing the endotoxin.
Dependencies are inferred from the claim text.