摘要:
This invention provides for a rapid and convenient method of simultaneous collection of both genomic and diagnostic information from a single sample on a bibulous pad by differential extraction of the diagnostic information from the genomic information. It is a surprising discovery of this invention that a PCR assay on the contents of the bibulous pad provides results comparable in reliability, specificity, and sensitivity to the best available serum (blood) based assays. The assays of this invention can be used to confirm each other, either by detecting the genomic information leading to the diagnostic information, or by detecting in the genomic information, a predisposition to a disease and confirming the presence of the disease through diagnostic testing.
摘要:
This invention provides for a rapid and convenient method of simultaneous collection of both genomic and diagnostic information from a single sample on a bibulous pad by differential extraction of the diagnostic information from the genomic information. It is a surprising discovery of this invention that a PCR assay on the contents of the bibulous pad provides results comparable in reliability, specificity, and sensitivity to the best available serum (blood) based assays. The assays of this invention can be used to confirm each other, either by detecting the genomic information leading to the diagnostic information, or by detecting in the genomic information, a predisposition to a disease and confirming the presence of the disease through diagnostic testing.
摘要:
A substitute oral fluid standard for testing, calibration, and standardization of devices and methods for collection, storage, and analysis of oral fluids. The oral fluid standard comprises a mucin and a protease inhibitor.
摘要:
A device for obtaining oral fluid containing substances for testing. In one embodiment, the device includes a syringe having a plunger at the end of which an absorbent pad is attached. A test assembly containing the device is also disclosed.
摘要:
A container for storing collected substances for subsequent testing having an open upper end adapted to be sealed with a removable stopper and a lower end having an opening communicating the interior of the container with the outside. The opening is selectively sealed by a frangible nipple during storage of the substances and unsealed for removal of the collected substances for subsequent testing. The distal end of the frangible nipple is enlarged, preferably in the form of a ball.
摘要:
Timed sensing of collection of saliva in a liquid collection element of predetermined volumetric capacity may be used to determine salivary secretion rate, as may be indicative of state of euhydration or dehydration. Sensing of salivary flow rate may be further augmented by sensing concentration of at least one analyte in saliva (e.g., with an immunochromatographic assay performed in a lateral flow device) in order to determine a state of euhydration or dehydration. Production of saliva may be stimulated, and collected saliva may be analyzed to generate an analyte detection signal that indicative of presence and/or correlative of concentration of at least one analyte in the collected saliva to sense a state of euhydration or dehydration.
摘要:
A device for collecting and transporting aqueous fluid from the oral cavity to a lateral chromatographic strip for test is disclosed. The lateral chromatographic strip is placed within and extend along a cavity defined in a housing. At least one inspection site to the lateral chromatographic strip is provided to enable inspection of selected sites on the lateral chromatographic strip for test results. A porous wick material protrudes from the housing to a collection site exterior of the housing at one end and communicates to the lateral chromatographic strip at the other end. The porous wick material has particulate construction, the particles adsorbing aqueous oral fluid to transport the fluid from the mouth to the lateral chromatographic strip without substantial absorption. The particles of the porous wick material are bound together to define a continuous interstitial volume for the flow of oral fluid to be transported and are treated to be hydrophilic to the adsorbed oral fluids. The porous wick material readily releases oral fluid to the lateral chromatographic strip. Prevention of reverse flow to the oral cavity from the lateral chromatographic strip naturally occurs due to the circuitous flow path of the porous wick material. A bite plate is coupled to the housing and insertable between the teeth of the patient to position the porous wick in the oral cavity for collecting the oral fluid. The bite plate is typically held in place by the occlusal force of the teeth, preferably the molars and/or the bicuspids, to position the porous wick in the buccal space. By observing the lateral chromatographic strip while the test device is in the mouth immediate test results are obtained.
摘要:
A device for testing an elastic membrane for permeability ot submicroscopic particles. The device has a first chamber to contain the particles in a fluid medium; a second chamber to contain a reagent for detecting the presence of any of the particles; suitable structure for mounting the membrane between the chambers in a fluid-tight manner so that the membrane separates the chambers; and a mechanism for applying stress to the membrane.
摘要:
Timed sensing of collection of saliva in a liquid collection element of predetermined volumetric capacity may be used to determine salivary secretion rate, as may be indicative of state of euhydration or dehydration. Sensing of salivary flow rate may be further augmented by sensing concentration of at least one analyte in saliva (e.g., with an immunochromatographic assay performed in a lateral flow device) in order to determine a state of euhydration or dehydration. Production of saliva may be stimulated, and collected saliva may be analyzed to generate an analyte detection signal that indicative of presence and/or correlative of concentration of at least one analyte in the collected saliva to sense a state of euhydration or dehydration.
摘要:
A method for rapid collection and assay of oral fluids is disclosed. The method comprising the steps of: (a) placing an assay device into an oral cavity, (b) removing said assay device from said oral cavity; and (c) determining the presence or absence of at least one analyte. The assay device used in the method comprises: (i) an assay portion housing an immunochrornatographic lateral flow assay strip, the lateral flow assay strip containing at least one reagent selected from an antigen and an antibody that is used to detect one of the presence or absence of at least one analyte in a fluid; (ii) a neck portion extending from the assay portion, the neck portion forming a channel for delivery of fluid to said assay strip and the channel being defined by a first, narrow part proximal to the assay portion and a second part including an opening for receiving the oral fluid, wherein the second part includes a channel width that is substantially wider than the channel width at the narrow end; (iii) a collection strip in fluid communication with the lateral flow assay strip, the collection strip having a first portion disposed within the channel and a second portion protruding outwardly from the neck portion opening; and (iv) a blocking strip coupled between and in flow communication with the lateral flow assay strip and the collection strip.