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.

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.

An optical sensing system includes a planar optical waveguide having a first surface for detection and a second surface for coupling light. The optical sensing system includes a functional layer integral with the first surface of the planar optical waveguide, and a coupling layer in contact with the second surface of the planar optical waveguide, the coupling layer having a lower refractive index than the planar optical waveguide. The optical sensing system includes an optical source arranged to illuminate at least a portion of the second surface of the planar optical waveguide through the coupling layer with substantially critical optical coupling. The optical sensing system also includes an optical detector arranged to receive a portion of light from the optical source after being reflected from the first surface of the planar optical waveguide and passing through the coupling layer.

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.

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.

An optical sensing system includes a planar optical waveguide having a first surface for detection and a second surface for coupling light. The optical sensing system includes a functional layer integral with the first surface of the planar optical waveguide, and a coupling layer in contact with the second surface of the planar optical waveguide, the coupling layer having a lower refractive index than the planar optical waveguide. The optical sensing system includes an optical source arranged to illuminate at least a portion of the second surface of the planar optical waveguide through the coupling layer with substantially critical optical coupling. The optical sensing system also includes an optical detector arranged to receive a portion of light from the optical source after being reflected from the first surface of the planar optical waveguide and passing through the coupling layer.