Abstract: The present invention relates to an in vitro assay method and device that provides for detection and measurement of entities in a fluid sample that can be captured and concentrated in a unitized self-contained enclosed filter apparatus that is analyzed in an optical detection instrument for indications of the entity. It provides for analysis of biological material including cells, their enzymes, or other constituents thereof, that can be identified based on an indicator-generating means. The analysis provided for include detection of the presence of the entity, and changes in the entity over time, such as associated with growth and increasing metabolic activity with an expanding population of cells, or decreasing metabolic activity, for example, due to presence of inhibitory or toxic agents.

Abstract: A method and device is provided for collecting filterable material to perform assays on a filtration apparatus by applying negative-pressure to the inlet chamber of the filtration apparatus which is independent of negative or positive pressure applied to its fluid path. The negative-pressure applied to the inlet chamber serves to actively aspirate fluid and promote flow into the inlet chamber via the fluid pathway. The negative-pressure applied to the inlet chamber facilitates the use of either negative or positive-pressure based fluid-filtration approaches. Use of the invention improves the functionality and scope of applications that can be performed with enclosed filtration apparatuses.

Abstract: There is disclosed a biological indicator (BI) test utilizing oxygen sensing within a microenvironment as a means for determining the presence of viable microorganisms capable of growth, a method for biological indicator (BI) testing for determining the completeness of a sterilization cycle utilizing oxygen sensing as the means for determining the presence of viable microorganism survival, a device for determining oxygen content in a biological indicator (BI) assay vessel containing an optical oxygen sensor, and a method and device for determining antimicrobial drug resistance or sensitivity to a contaminated sample.

Abstract: There is disclosed an apparatus and method for detecting and measuring volatile acidic or basic components including ammonia, ammonium, or volatile amines (compound) in a gas or liquid state fluid. Specifically, the present invention provides a PTFE-carrier solid phase indicator film having an ammonia-sensitive indicator dye embedded therein, such that the dye moiety changes color or spectral properties upon exposure to the compound to be detected.

Abstract: A method and device is provided for collecting filterable material to perform assays on a filtration apparatus by applying negative-pressure to the inlet chamber of the filtration apparatus which is independent of negative or positive pressure applied to its fluid path. The negative-pressure applied to the inlet chamber serves to actively aspirate fluid and promote flow into the inlet chamber via the fluid pathway. The negative-pressure applied to the inlet chamber facilitates the use of either negative or positive-pressure based fluid-filtration approaches. Use of the invention improves the functionality and scope of applications that can be performed with enclosed filtration apparatuses.

Abstract: The present invention relates to an in vitro assay method and device that provides for detection and measurement of entities in a fluid sample that can be captured and concentrated in a unitized self-contained enclosed filter apparatus that is analyzed in an optical detection instrument for indications of the entity. It provides for analysis of biological material including cells, their enzymes, or other constituents thereof, that can be identified based on an indicator-generating means. The analyses provided for include detection of the presence of the entity, and changes in the entity over time, such as associated with growth and increasing metabolic activity with an expanding population of cells, or decreasing metabolic activity, for example, due to presence of inhibitory or toxic agents.

Abstract: There is disclosed an apparatus and method for detecting and measuring volatile acidic or basic components including ammonia, ammonium, or volatile amines (compound) in a gas or liquid state fluid. Specifically, the present invention provides a PTFE-carrier solid phase indicator film having an ammonia-sensitive indicator dye embedded therein, such that the dye moiety changes color or spectral properties upon exposure to the compound to be detected.

Abstract: A rapid, non-invasive breath-test method and device for diagnosing the presence or absence of H. pylori in a subject without administration of isotopic tracers is described. The device consists of a highly sensitive colorimetric ammonia sensor placed in contact with sampled subject breath. The sensor is measured using appropriate reflection spectroscopy instrumentation. The breath-test method consists of measuring a basal ammonia level with the device, administering non-isotopic urea and continuing measurement of the ammonia content in a plurality of consecutive breaths. Diagnostic differences in breath ammonia are identified between H. pylori infected and uninfected individuals.

Abstract: A rapid, non-invasive breath-test method and device for diagnosing the presence or absence of H. pylori in a subject without administration of isotopic tracers is described. The device consists of a highly sensitive colorimetric ammonia sensor placed in contact with sampled subject breath. The sensor is measured using appropriate reflection spectroscopy instrumentation. The breath-test method consists of measuring a basal ammonia level with the device, administering non-isotopic urea and continuing measurement of the ammonia content in a plurality of consecutive breaths. Diagnostic differences in breath ammonia are identified between H. pylori infected and uninfected individuals.

Abstract: There is disclosed an apparatus and method for detecting and measuring volatile acidic or basic components including ammonia, ammonium, or volatile amines (compound) in a gas or liquid state fluid. Specifically, the present invention provides a PTFE-carrier solid phase indicator film having an ammonia-sensitive indicator dye embedded therein, such that the dye moiety changes color or spectral properties upon exposure to the compound to be detected.

Abstract: A bundle of fiber-optic sensors that resist breakage, for use in measuring pH, CO.sub.2, and O.sub.2 concentration, and a method of making the same. Three otpical fibers are enclosed in a common polyimide sheath and extend parallel to one another toward a distal end of the sensor, where they are bonded together in a mutually supportive array. At the distal end of one of these optical fibers is disposed a pellet comprising a CO.sub.2 analyte indicator molecule codissolved within a polymer matrix. A thin reflective surface of gold foil is provided on the pellet such that incident light transmitted through the optical fiber and polymer matrix is reflected back into the optical fiber. The CO.sub.2 polymer matrix absorbs light of a given wavelength to an extent dependent upon the level of CO.sub.2 present.