Abstract: This disclosure relates to verifying the operation of cell analyzers, including microscope-based cell imaging and counting analyzers. In one general aspect, a mixture of micro-beads having known characteristics is introduced into the analyzer. One or more images of the mixture are acquired with the analyzer's microscope, the images are analyzed, and a determination is made about whether results meet one or more predetermined quality control thresholds. Also disclosed is a hematology control material that can be used to perform the verification and includes a solvent, a dye dissolved in the solvent, and micro-beads suspended in the solvent. In another general aspect, a quality control method for the analyzers includes capturing images of samples that include patient cells using at least a microscope, extracting sample-specific information about properties of the patient samples from the images, and testing information from the samples against predetermined standards to verify the operation of the analyzer.

Abstract: This disclosure describes single-use test cartridges, cell analyzer apparatus, and methods for automatically performing microscopic cell analysis tasks, such as counting and analyzing blood cells in biological samples. A small measured quantity of a biological sample, such as whole blood, is placed in a mixing bowl on the disposable test cartridge after being inserted into the cell analyzer. The analayzer also deposits a known amount of diluent/stain in the mixing bowl and mixes it with the blood. The analyzer takes a measured amount of the mixture and dispenses in a sample cup on the cartridge in fluid communication with an imaging chamber. The geometry of the imaging chamber is chosen to maintain the uniformity of the mixture, and to prevent cells from crowding or clumping as it is transferred into the imaging chamber by the analyzer. Images of all of the cellular components within the imaging chamber are counted and analyzed to obtain a complete blood count.

Abstract: Disclosed in one aspect is a method for performing a complete blood count (CBC) on a sample of whole blood by metering a predetermined amount of the whole blood and mixing it with a predetermined amount of diluent and stain and transferring a portion thereof to an imaging chamber of fixed dimensions and utilizing an automated microscope with digital camera and cell counting and recognition software to count every white blood cell and red blood corpuscle and platelet in the sample diluent/stain mixture to determine the number of red cells, white cells, and platelets per unit volume, and analyzing the white cells with cell recognition software to classify them.

Abstract: This disclosure describes single-use test cartridges, cell analyzer apparatus, and methods for automatically performing microscopic cell analysis tasks, such as counting blood cells in biological samples. A small unmeasured quantity of a biological sample such as whole blood is placed in the disposable test cartridge which is then inserted into the cell analyzer. The analyzer isolates a precise volume of the biological sample, mixes it with self-contained reagents and transfers the entire volume to an imaging chamber. The geometry of the imaging chamber is chosen to maintain the uniformity of the mixture, and to prevent cells from crowding or clumping, when it is transferred into the imaging chamber. Images of essentially all of the cellular components within the imaging chamber are analyzed to obtain counts per unit volume.

Abstract: This disclosure relates to verifying the operation of cell analyzers, including microscope-based cell imaging and counting analyzers. In one general aspect, a mixture of micro-beads having known characteristics is introduced into the analyzer. One or more images of the mixture are acquired with the analyzer's microscope, the images are analyzed, and a determination is made about whether results meet one or more predetermined quality control thresholds. Also disclosed is a hematology control material that can be used to perform the verification and includes a solvent, a dye dissolved in the solvent, and micro-beads suspended in the solvent. In another general aspect, a quality control method for the analyzers includes capturing images of samples that include patient cells using at least a microscope, extracting sample-specific information about properties of the patient samples from the images, and testing information from the samples against predetermined standards to verify the operation of the analyzer.

Abstract: This disclosure describes single-use test cartridges, cell analyzer apparatus, and methods for automatically performing microscopic cell analysis tasks, such as counting and analyzing blood cells in biological samples. A small measured quantity of a biological sample, such as whole blood, is placed in a mixing bowl on the disposable test cartridge after being inserted into the cell analyzer. The analyzer also deposits a known amount of diluent/stain in the mixing bowl and mixes it with the blood. The analyzer takes a measured amount of the mixture and dispenses in a sample cup on the cartridge in fluid communication with an imaging chamber. The geometry of the imaging chamber is chosen to maintain the uniformity of the mixture, and to prevent cells from crowding or clumping as it is transferred into the imaging chamber by the analyzer. Images of all of the cellular components within the imaging chamber are counted and analyzed to obtain a complete blood count.

Abstract: A lateral flow immunoassay system is provided that includes a housing having a base portion forming a first chamber therein and a body portion formed with three openings in fluid communication with the first chamber, a vial containing a buffer agent, and a sample collector for introducing a sample fluid into the first chamber via the second opening. The vial is mounted to the housing such that a dispensing side extends into the first opening for dispensing the buffer agent therefrom into the first chamber. The housing allows the buffer agent and sample fluid to be mixed within a reaction well formed within the first chamber to form a test sample mixture. The body portion is configured to receive a receiving end of an elongated holder in the third opening and allow a test strip secured in the holder to be brought into communication with the text sample mixture.

Abstract: This disclosure describes single-use test cartridges, cell analyzer apparatus, and methods for automatically performing microscopic cell analysis tasks, such as counting blood cells in biological samples. A small unmeasured quantity of a biological sample such as whole blood is placed in the disposable test cartridge which is then inserted into the cell analyzer. The analyzer isolates a precise volume of the biological sample, mixes it with self-contained reagents and transfers the entire volume to an imaging chamber. The geometry of the imaging chamber is chosen to maintain the uniformity of the mixture, and to prevent cells from crowding or clumping, when it is transferred into the imaging chamber. Images of essentially all of the cellular components within the imaging chamber are analyzed to obtain counts per unit volume.

Abstract: An automated chemistry analysis method is disclosed. In one general aspect, the method includes receiving a modular chemistry analysis test unit that includes one or more vessels for one or more reagents, and a machine-readable test specification coupled with the vessels. The method also includes defining a test that defines a test including a series of operations that employ the reagents for the vessels, and installing the chemistry analysis test unit in a first chemistry analyzer that includes one or more analysis tools and sequencing logic for sequencing instructions to be carried out by the analysis tools. The machine-readable test specification is automatically received from the chemistry analysis test module and stored for access by the sequencing logic to allow the sequencing logic to instruct the analysis tools to carry out the test defined by the test specification.

Abstract: A lateral flow immunoassay system is provided that includes a housing having a base portion forming a first chamber therein and a body portion formed with three openings in fluid communication with the first chamber, a vial containing a buffer agent, and a sample collector for introducing a sample fluid into the first chamber via the second opening. The vial is mounted to the housing such that a dispensing side extends into the first opening for dispensing the buffer agent therefrom into the first chamber. The housing allows the buffer agent and sample fluid to be mixed within a reaction well formed within the first chamber to form a test sample mixture. The body portion is configured to receive a receiving end of an elongated holder in the third opening and allow a test strip secured in the holder to be brought into communication with the text sample mixture.

Abstract: A chemistry analyzer is disclosed that can include a unitary base with vertical and horizontal supports for constraining subassemblies. The subassemblies include at least a reagent/sample carousel subassembly, a transfer arm subassembly, and a reaction carousel subassembly. A centralized hydraulic system can also be provided behind a user access panel. The analyzer can use machine-readable test specifications coupled with its reagent vessels to define tests that include operations that employ the reagents. The analyzer can also display to the operator a pictorial representation that includes graphical elements that convey levels of usage for the storage vessels, and access icons that are each associated with a color and each lead to a set of screens for different types of operations for the analyzer.

Abstract: Devices and methods for testing a biological sample for an analyte of interest are provided that make use of a reaction chamber for receiving a reaction mixture, a housing positioned below the reaction chamber for receiving a test cassette, and a door that is positioned in the top portion of the housing. The door includes a ramp that extends downwardly into the housing such that biasing the ramp upwards opens the door into the cavity of the reaction chamber and places the reaction chamber in fluid communication with the insertion area to thereby allow the reaction mixture to flow onto a test cassette and allow for the determination of an amount of an analyte of interest.

Abstract: An extraction method and apparatus is provided for obtaining quick, safe and highly sensitive testing of a variety of body fluids including saliva, blood, urine or other fluids for drugs of abuse or other analytes. The apparatus includes a latchable extraction wand for obtaining body fluid samples from a subject which is adapted to maximize the portion of the body fluid sample that will go into a graduated bottle containing a buffer solution, and a testing device wherein the sample will be received and into which test strips can be inserted to determine levels of drugs of abuse or other analyte in the sample. In one of the methods of the invention, energy is imparted to the sample and buffer solution, such as by shaking, and this facilitates reduction of sample viscosity, such as by promoting the breakdown of mucins when the sample is saliva.

Abstract: An apparatus for promoting the clotting of blood and controlling bleeding comprises a receptacle for retaining blood clotting material in particulate form therein. A pad for controlling bleeding comprises a mesh structure and a support attached to the mesh structure to facilitate the application of pressure to the pad and the wound. A bandage applicable to a bleeding wound comprises a mesh structure and a flexible substrate attached to the mesh structure, the substrate being a cloth or plastic member that may be adhesively attachable to cover a wound. In any embodiment, at least a portion of the receptacle or mesh structure is defined by a mesh having openings therein, and at least a portion of the particulate blood clotting material is in direct contact with blood. The mesh may include a zeolite powder impregnated or otherwise incorporated therein.

Abstract: An apparatus for promoting the clotting of blood and controlling bleeding comprises a receptacle for retaining molecular sieve material in particulate form therein. A pad for controlling bleeding comprises a mesh structure and a rigid or semi-rigid support attached to the mesh structure to facilitate the application of pressure to the pad and the wound. A bandage applicable to a bleeding wound comprises a mesh structure and a flexible substrate attached to the mesh structure, the substrate being a cloth or plastic member that may be adhesively attached to cover a wound. In any embodiment, at least a portion of the receptacle or mesh structure is defined by a mesh having openings therein, and at least a portion of the particulate molecular sieve material is in direct contact with blood.

Abstract: A device for promoting the clotting of blood comprises a clay material in particle form and a receptacle for containing the clay material. At least a portion of the receptacle is defined by a mesh. Another device comprises a gauze substrate and a clay material disposed on the gauze substrate. Another device is a bandage comprising a substrate, a mesh mounted on the substrate, and particles of a clay material retained in the mesh. A hemostatic sponge comprises a substrate, a hemostatic material disposed on a first surface of the substrate, and a release agent disposed on a second surface of the substrate. The release agent is disposed on the wound-contacting surface of the substrate. When treating a bleeding wound, application of the hemostatic sponge causes at least a portion of the hemostatic material to come into contact with blood through the release agent and through the substrate.

Abstract: A method and device are provided for stimulating and increasing the production of saliva during immunoassay tests for drugs or other analytes wherein a scent or odor capable of stimulating saliva production is incorporated into a device for obtaining an oral sample from a test subject. The scent or odor may be impregnated into the oral sample collection device or may be part of an attachment to such a device, and the scent or odor is disposed in such a manner so as to maximize the exposure of the scent to the test subject and thus stimulate the production of saliva. The method and device of the invention are advantageous because the increased production of saliva will facilitate the testing of an oral sample for drugs or other analytes and will increase the likelihood of obtaining a complete and accurate result.

Abstract: A device for promoting the clotting of blood comprises a clay material in particle form and a receptacle for containing the clay material. At least a portion of the receptacle is defined by a mesh. Another device comprises a gauze substrate and a clay material disposed on the gauze substrate. Another device is a bandage comprising a substrate, a mesh mounted on the substrate, and particles of a clay material retained in the mesh. A hemostatic sponge comprises a substrate, a hemostatic material disposed on a first surface of the substrate, and a release agent disposed on a second surface of the substrate. The release agent is disposed on the wound-contacting surface of the substrate. When treating a bleeding wound, application of the hemostatic sponge causes at least a portion of the hemostatic material to come into contact with blood through the release agent and through the substrate.

Abstract: A device for promoting the clotting of blood comprises a clay material in particle form and a receptacle for containing the clay material. At least a portion of the receptacle is defined by a mesh. Another device comprises a gauze substrate and a clay material disposed on the gauze substrate. Another device is a bandage comprising a substrate, a mesh mounted on the substrate, and particles of a clay material retained in the mesh. A hemostatic sponge comprises a substrate, a hemostatic material disposed on a first surface of the substrate, and a release agent disposed on a second surface of the substrate. The release agent is disposed on the wound-contacting surface of the substrate. When treating a bleeding wound, application of the hemostatic sponge causes at least a portion of the hemostatic material to come into contact with blood through the release agent and through the substrate.