Abstract: The illustrated embodiment comprises a biosensor utilizing plant cells and nutrient media for maintaining the plant cells in a live condition. A light source having desired optical characteristics is directed onto the plant cells and light spectra transmitted from the cells is detected by a photodetector. A controller analyzes signals from the photodetector to detect a state change in the plant cells in response to exposure to an agent.

Abstract: A gasket for use with sanitary piping systems contains a receptacle for retaining an encapsulated bacterial test indicator. The receptacle has a length that permits the indicator end of the test indicator to be directly exposed to the sterilizing steam that is introduced into the piping system. The gasket is preferably installed at the sanitary flange of a short “bull” T-section of the stainless steel sanitary piping and secured thereto by a stainless steel cap. The stainless steel cap is recessed to accommodate as much of the test indicator length as may be required to position the indicator end of the test indicator in the central lumen of smaller pipe diameters.

Abstract: A self-contained biological indicator for evaluating the effectiveness of a sterilizer utilizing an anti-microbial gas or liquid fluid. The indicator is comprised of a tubular casing having open ends and defining an interior chamber. A source of viable microorganisms is disposed within the chamber. A frangible ampoule containing a culture medium capable of promoting growth of the microorganism and a detector means capable of reaction with the metabolites of the microorganism to produce a visual indication is disposed within the chamber. The ampule is operable by pressure applied to an external surface thereof to permit the microorganism and the medium to come into contact with each other. A cap assembly is mounted to each end of the tubular casing. Each cap assembly includes a telescoping element movable from a first position defining an opening communicating with the chamber and a second position crushing the ampoule and forming a gas/fluid impermeable seal around the chamber.

Abstract: Disc assay devices and methods for the detection and enumeration of microorganisms are disclosed. The devices and methods include a plurality of discs attached to a substrate and a reflector on one surface of each of the discs to reflect electromagnetic energy of selected wavelengths after the energy has passed through the disc. The reflector may be useful to improve the accuracy of detection and/or enumeration of target microorganisms on the assay devices. A system for detecting and/or enumerating target microorganisms on disc assay devices is also provided.

Abstract: An improved microfabricated apparatus for conducting a multiplicity of individual and simultaneous binding reactions is described. The apparatus comprises a substrate on which are located discrete and isolated sites for binding reactions. The apparatus is characterized by discrete and isolated regions that extend through said substrate and terminate on a second surface thereof such that when a test sample is applied to the substrate, it is capable of penetrating through each such region during the course of said binding reaction. The apparatus is especially useful for sequencing by hybridization of DNA molecules.

Abstract: A microbiological analyzer for performing ID tests on samples using colorimetric techniques to generate a pixel-wise colored map of a test region of interest and also performing MIC tests on samples using nephelometric techniques to determine which antimicrobial agents are most effective against a particular microorganism.

Abstract: A Biological Indicator Evaluator Resistometer (BIER vessel) provides enhancements in controlling the start and end points of exposure to a sterilant gas. The end point control employs a large volume relative to the test chamber volume upon which is drawn a deep vacuum and then exposed to the test chamber to quickly exhaust the sterilant gas from the test chamber.

Abstract: An apparatus for detecting biofilm in the water conduits of dental units, especially biofilm adhering to the inside surfaces of the conduits, can be used on a water line equipped with a plurality of conduits for supplying fluids to handpieces and fluid consuming units that use fluid from a main supply or accessory fluids from corresponding independent lines. A portion of one of the conduits is equipped with a system for detecting the presence of the biofilm on the surfaces of the portion itself. The invention also relates to a method for detecting the biofilm. The method comprises the steps of contacting the biofilm attached to surfaces with a reagent substance or fluid; altering the biofilm by the reagent substance or fluid; and detecting the alteration that has taken place in the biofilm using the detecting system.

Abstract: A system for detection and treatment of chemical weapons and/or biological pathogens uses a detector system, an electrostatic precipitator or scrubber, a circulation system, and a control. The precipitator or scrubber is activated in response to a signal from the detector upon the detection of chemical weapons and/or biological pathogens.

Abstract: A process challenge device and method of using the same is presented for testing the efficiency of various sterilization procedures on objects to be sterilized. The device is assembled from two tapered end portions having opposite open ends and an open pathway extending therethrough. A central chamber in the open pathway receives a Biological Indicator for testing the efficiency of the sterilization process. The device is ideal for testing a sterilization process on elongated objects such as tubing, at any point along their length. The coupling structures on the end portions provide the device with single-use security.

Abstract: A compact bio-sensor is provided, particularly suitable for measuring biological oxygen demand, which includes micro-organisms for altering a biological parameter and sensors upstream and downstream of the organisms.

Abstract: A process challenge device tailored to mimic the resistance of a particular product-package combination to a particular biological inactivation, disinfection, or sterilization process. The device is used to challenge the process, thus providing a means to validate the efficacy of the process. In one embodiment, the process indicator includes a biological indicator organism stored on a carrier enclosed within a chamber formed by a barrier film material. The specific indicator organism and carrier substrate are chosen for their appropriateness for a given process. The materials comprising the barrier film material of the process challenge device are chosen for the materials' specific resistance to the given process. The process challenge device may also comprise a separate second chamber filled with an appropriate culture medium or enzyme substrate that is separated from the chamber containing the process indicator by a separation means, such as a valve, a clip, or a frangible separation.

Abstract: A device for culturing microorganisms and its use are described. The claimed device comprises a substrate having a top side, a pedestal mounted on the top side of the substrate and comprising a non-absorbent culture surface, a flexible cover sheet attached to the substrate and comprising a bottom surface, the cover sheet being configured to cover the culture surface, and a culture medium deposited on one or more surfaces selected from: the culture surface, and the cover sheet bottom surface. An aqueous sample is spread and contained by the claimed device without additional equipment or manipulation by the end user.

Abstract: An elongate canister having a generally rectangular cross-section sized to house a plurality of antibiotic susceptibility test arrays stacked one atop another and maintained secure within an environmentally controlled inventory chamber in a random access microbiological analyzer.

Abstract: A rapid method of determining the efficacy of a sterilization cycle, and an indicator adapted to perform such method, comprising subjecting to the sterilization cycle a source of active enzyme having activity which correlates with the viability of a microorganism commonly used to monitor sterilization, and incubating the enzyme source, following the completion of the sterilization cycle, with an effective amount of a substrate system capable of reacting with any residual active enzyme to produce a detectable enzyme-modified product.

Abstract: A sterilization indicator is useful for testing the effectiveness of sterilization procedures that disinfect objects by contacting them with a liquid sterilization procedure. The indicator includes an outer container having an open end and a cover material associated with the open end that is impermeable to liquids and bacteria. An enzyme-gel matrix is coated on a surface within the outer container that comprises a biologically inert polymeric gel and a source of an active enzyme dispersed within the gel. The enzyme has an activity that is correlated with the survival of at least one test microorganism that is commonly used to monitor the effectiveness of a sterilization procedure. A breakable ampoule within the outer container contains a substrate that is capable of reacting with any active enzyme remaining after the indicator has been subjected to a sterilization procedure to provide a detectable indication that the sterilization procedure was ineffective.

Abstract: This invention relates to a container and method for detecting a specific environmental parameter or combination of parameters, or for determining the effectiveness of a sterilization procedure. The invention relates to test indicators containing controlled volumes of compressed, gas-permeable materials, and modified caps comprising one or more apertures, sterilant permeable inserts, protruding members, or a combination thereof, and to methods for using test indicators for determining the efficacy of different types of sterilization processes. If proper sterilization conditions are not met, the interactive enzyme system remains active, and a color product forms upon the addition of the remaining components of the enzyme system. If the proper sterilization conditions are met, the sterilant destroys the interactive enzymes and no color product is formed. Inactivation of the enzyme system parallels the inactivation of bacterial spores subjected to the sterilization process.

Abstract: Envelopes and other containers intended for mail transportation possess a biological agent/toxin indicator operative upon the interior in detection of volatile bases including gaseous amines released from bacterial biological agents including Bacillus antracis, i.e. anthrax. The biological agent indicator has an acidic acid-base indicator compound that irreversibly changes color when neutralized by volatile bases. The compound is applied in liquid form to an appropriately porous substrate. A polymeric matrix is specifically suggested for this substrate. Irreversible indication of the presence of volatile bases including amines produced by live bacterial agents as toxins at temperate ambient conditions down to below freezing is provided. An indicator compound having a pH of 2-5 is recommended. Halogenated xanthene, sulphonated azo, and sulphonated hydroxy-functional triphenylmethane dyes are suggested.

Abstract: An apparatus for determining microorganisms in liquid test specimens includes a specimen providing station (10) with a transport apparatus (32, 36) for the continuous provision of cuvettes (26) containing specimens to be investigated, a dosing station (12) with a pipetting apparatus (14) for removing specimens from cuvettes (26) and for filling the specimens into measuring chambers formed in a measuring chamber plate (86) in matrix arrangement, a measuring station (16) with a measuring apparatus (146) for optically measuring the specimens in the measuring chambers and an endless conveyor (18) for serially receiving the measuring chamber plates (86) and for transporting the same through a dosing station (12), a measuring station (16) and through a temperature controllable waiting zone (22).

Abstract: A method and an apparatus for preventing reversion of the color of an indicator dye in a biological indicator is disclosed. The indicator dye changes color if viable microorganisms are present after sterilization, because acidic byproducts are formed when the microorganisms metabolize the growth medium. It has been found that the dye can change color back to the original color after the completion of the sterilization due to leaching or diffusion of basic impurities into the growth medium. The method and the apparatus employ a dual buffer system with one buffer which operates at high pH to moderate pH fluctuations at the start of the sterilization and a second buffer which operates at low pH to minimize pH fluctuations after the sterilization is complete. Less high pH buffer than low pH buffer is used in order to maximize the speed and sensitivity of the biological indicator.

Abstract: A sterilization indicator is useful for testing the effectiveness of sterilization procedures that disinfect objects by contacting them with a liquid sterilization procedure. The indicator includes an outer container having an open end and a cover material associated with the open end that is impermeable to liquids and bacteria. An enzyme-gel matrix is coated on a surface within the outer container that comprises a biologically inert polymeric gel and a source of an active enzyme dispersed within the gel. The enzyme has an activity that is correlated with the survival of at least one test microorganism that is commonly used to monitor the effectiveness of a sterilization procedure. A breakable ampoule within the outer container contains a substrate that is capable of reacting with any active enzyme remaining after the indicator has been subjected to a sterilization procedure to provide a detectable indication that the sterilization procedure was ineffective.

Abstract: A method and an apparatus for preventing reversion of the color of an indicator dye in a biological indicator is disclosed. The indicator dye changes color if viable microorganisms are present after sterilization, because acidic byproducts are formed when the microorganisms metabolize the growth medium. It has been found that the dye can change color back to the original color after the completion of the sterilization due to leaching or diffusion of basic impurities into the growth medium. The method and the apparatus employ a dual buffer system with one buffer which operates at high pH to moderate pH fluctuations at the start of the sterilization and a second buffer which operates at low pH to minimize pH fluctuations after the sterilization is complete. Less high pH buffer than low pH buffer is used in order to maximize the speed and sensitivity of the biological indicator.

Abstract: A device for examining the sterility of fluids, in particular of pharmaceutical products is proposed. The device comprises a diaphragm filter inserted into a filtering unit for sterile filtration of the fluid, a collecting container which can be connected with the outlet of the filtering unit for the filtered matter and a container receiving at least one nutrition medium for incubation of the diaphragm filter to detect microorganisms. In accordance with the invention, the diaphragm filter can be inserted into and removed from the filtering unit by means of a handling device and be transferred by same, without contact, into the container receiving the nutrition medium such that, before incubation of the diaphragm filter, contamination of the diaphragm filter and of the nutrition medium is largely prevented to suppress erroneous positive results. The diaphragm filter preferably comprises a large surface and is substantially cylindrical, conical or tapered.

Abstract: A test device and a method for assessing the biocidal efficacy of a liquid are disclosed.

Abstract: A method for the use of a phage associated lysing enzyme for the detecting the presence and determining the quantity of bacteria present in or on a wide variety of substances is described. The total concentration of microbes is determined by adding or incorporating a phage associated lytic agent to a disposable test system device with the luminescent reagents luciferin and luciferase, and introducing the disposable test system into a luminometer that can read the luminescence. Other systems can be used with the lytic enzymes for the quantitative and qualitative determination for the presence of bacteria.

Abstract: An apparatus for determining exposure to an oxidative sterilant is described. The apparatus includes a chemical indicator for indicating exposure to the oxidative sterilant and a biological indicator for determining the effectiveness of the exposure to the oxidative sterilant. The chemical indicator has a metallic surface with a non-pH sensitive permanent indicator on the surface for indicating exposure to the oxidative sterilant. The chemical indicator may be on a self-contained biological indicator. The biological indicator and chemical indicator may be inside a test pack, where the test pack restricts sterilant flow to the indicators.

Abstract: A diagnostic microbiological testing system and method for microorganism identification (ID) and antimicrobial susceptibility determinations (AST). The system includes multiple-well test panels capable of performing ID and AST testing on the same test panel. Each test panel is inoculated with reagents, broth-suspended organisms, and placed into the instrument system. The instrument system includes a rotating carousel for incubation and indexing, multiple light sources each emitting different wavelength light, precision calorimetric and fluorometric detection, barcode test panel tracking and a control processor for making determinations based on measured test data. One light source includes a plurality of LEDs arranged in a linear array. Each of the LEDs' junction currents are controllable to produce a predetermined illumination profile.

Abstract: A sterilization indicator is useful for testing the effectiveness of sterilization procedures that disinfect objects by contacting them with a liquid sterilization procedure. The indicator includes an outer container having an open end and a cover material associated with the open end that is impermeable to liquids and bacteria. An enzyme-gel matrix is coated on a surface within the outer container that comprises a biologically inert polymeric gel and a source of an active enzyme dispersed within the gel. The enzyme has an activity that is correlated with the survival of at least one test microorganism that is commonly used to monitor the effectiveness of a sterilization procedure. A breakable ampoule within the outer container contains a substrate that is capable of reacting with any active enzyme remaining after the indicator has been subjected to a sterilization procedure to provide a detectable indication that the sterilization procedure was ineffective.

Abstract: A sterilization system uses a sterilization process monitoring device which is capable of indicating the efficacy of the sterilization process. To enhance accuracy of the monitoring function, the monitoring device is located in such a fashion that an antimicrobial agent used in the process can only reach the monitor through an area containing the article to be sterilized.

Abstract: Thermal sterilization indicator process, apparatus and test indicator product which enable indication of microbial sterility achieved during a thermal sterilizer cycle by measuring visible light absorption due to chemical change in an encapsulated liquid indicator material, including measurements taken when a thermal sterilizer cycle is completed without a time delay requirement for spore growth, and in which the liquid indicator material includes a growth nutrient and microbes, so as to enable verification of achieved microbial sterility by measurement of the liquid indication subsequent to an incubation period following completion of the thermal sterilizer cycle.

Abstract: An analytical system comprises a frame and movable carriage. An analytical rotor is mounted on the carriage and can be translated among a sample dispensing station, a fluid dispensing station, and a label detection zone. In order to perform assays, the analyzer system requires only the introduction of the analytical rotor, sample, and a volume of diluent solution. Sample within the analyzer is contained at all times within either a sample receptacle or the rotor. The method allows for the sequential addition of sample and diluent in order to perform multiple assay steps and is particularly suitable for performing heterogeneous immunoassays. The use of fluorescent label in the system allows multiple analyte detection reactions to be performed from a single sample applied to a single rotor.

Abstract: A portable cassette is disclosed, for receiving, maintaining and growing biological cells ex vivo, without exposing the cells to the external environment. The portable cassette is used in combination with a succession of instruments, to inoculate the cassette's cell growth chamber with cells, to then incubate the chamber so that the cells are optimally expanded, and finally to harvest the expanded cells. Each instrument is configured to condition the portable cassette during a stage of the cell growth process, without disturbing the cassette's sterile system. In addition, an updatable memory device associated with the cassette stores significant information about the cassette and its condition during the various steps of the cell growth process. Such information is useful both for subsequent archival purposes and for facilitating a resumption of the cell growth process in the event of any instrument failure or significant alarm condition.

Abstract: A sterilization system using a sterilization process monitoring device which is capable of indicating the efficacy of the sterilization process in an enclosed sterilization container while still maintaining the sealed state of the sterilization container. The process monitoring device comprises at least one biological indicator and/or at least one chemical indicator. Upon completion of the sterilization cycle, the process monitoring device can be advantageously removed from the system to determine chemical and/or biological efficacy of the sterilization process. The removal of the biological and/or chemical indicators does not disturb the sterilized state of the articles inside the sterilization container.

Abstract: The present invention is a disposable element for assaying food samples and a method for using the element. The disposable element includes a container having first, second, and third ports, a prefilter disposed in the container, an immuno-sorbent layer having antibodies to a target microbe affixed thereto, the immuno-sorbent layer also being disposed in the container, and an electrode in contact with the immuno-sorbent layer. The prefilter and immuno-sorbent layers are positioned in the container such that a sample introduced into the first port passes through the prefilter and the immuno-sorbent layer when a pressure differential is created between the first and third ports. In addition, liquid entering the second port passes through the immuno-sorbent layer, but not the prefilter, when a pressure differential is created between the second and third ports. The prefilter preferably has a pore size between 10 and 30 microns.