Abstract: A control solution packet for calibrating a bodily fluid sampling device includes a container, a control solution pressurized within the container, and a membrane for covering and sealing the container. The control solution can be pressurized before or during calibration so as to ensure the appropriate amount of control solution is delivered to the bodily fluid sampling device. The control solution is manufactured to have a viscosity that controls delivery of the control solution to the device. The membrane is permeable by a piercing device of the bodily fluid sampling device and seals around the piercing device during calibration. In another aspect, the container is in the form of a capsule or dosing attachment that contains the control solution along with a sponge-like material.

Abstract: An electrochemical test device is provided for determining the presence or concentration of an analyte in an aqueous fluid sample. The electrochemical test device includes a working electrode and a counter electrode made of an amorphous semiconductor material. The working electrode is overlaid with a reagent capable of reacting with an analyte to produce a measurable change in potential which can be correlated to the concentration of the analyte in the fluid sample. The test device optionally contains a reference electrode made of an amorphous semiconductor material having a reference material on the reference electrode. The test device electrodes can be constructed on a flexible film substrate, such as a polymeric film or a metal foil coated with a non-conductive coating.

Abstract: An electrochemical test device is provided for determining the presence or concentration of an analyte in an aqueous fluid sample. The electrochemical test device includes a working electrode and a counter electrode made of an amorphous semiconductor material. The working electrode is overlaid with a reagent capable of reacting with an analyte to produce a measurable change in potential which can be correlated to the concentration of the analyte in the fluid sample. The test device optionally contains a reference electrode made of an amorphous semiconductor material having a reference material on the reference electrode. The test device electrodes can be constructed on a flexible film substrate, such as a polymeric film or a metal foil coated with a non-conductive coating.

Abstract: A method of making strip for testing for the presence of an analyte generally comprises providing a support member which includes a spreading layer and a reagent layer, and a capillary in communication with the support layer and spreading layer for transporting a sample of body fluid thereto.

Abstract: A multi-use assay system accurately docks a removable test strip supporting a reagent-analyte reaction with an optics system including an LED, photodetector, and lenses or light pipes for directing light to and from the test strip. Docking is achieved using alignment fixturing, whereby an optics block holder is relied upon to align the test strip and test pad with the various optical components. Signals from the photodetector indicative of test strip reaction progress are provided to a processor for measuring the analyte.

Abstract: An electrochemical test device is provided for determining the presence or concentration of an analyte in an aqueous fluid sample. The electrochemical test device includes a working electrode and a counter electrode made of an amorphous semiconductor material. The working electrode is overlaid with a reagent capable of reacting with an analyte to produce a measurable change in potential which can be correlated to the concentration of the analyte in the fluid sample. The test device optionally contains a reference electrode made of an amorphous semiconductor material having a reference material on the reference electrode. The test device electrodes can be constructed on a flexible film substrate, such as a polymeric film or a metal foil coated with a non-conductive coating.

Abstract: An electrochemical test device is provided for determining the presence or concentration of an analyte in an aqueous fluid sample. The electrochemical test device includes a working electrode and a counter electrode made of an amorphous semiconductor material. The working electrode is overlaid with a reagent capable of reacting with an analyte to produce a measurable change in potential which can be correlated to the concentration of the analyte in the fluid sample. The test device optionally contains a reference electrode made of an amorphous semiconductor material having a reference material on the reference electrode.

Abstract: An electrochemical test device is provided for determining the presence or concentration of an analyte in an aqueous fluid sample. The electrochemical test device includes a working electrode and a counter electrode made of an amorphous semiconductor material. The working electrode is overlaid with a reagent capable of reacting with an analyte to produce a measurable change in potential which can be correlated to the concentration of the analyte in the fluid sample. The test device optionally contains a reference electrode made of an amorphous semiconductor material having a reference material on the reference electrode. The test device electrodes can be constructed on a flexible film substrate, such as a polymeric film or a metal foil coated with a non-conductive coating.

Abstract: A multi-use assay system accurately docks a removable test strip supporting a reagent-analyte reaction with an optics system including an LED, photodetector, and lenses or light pipes for directing light to and from the test strip. Docking is achieved using alignment fixturing, whereby an optics block holder is relied upon to align the test strip and test pad with the various optical components. Signals from the photodetector indicative of test strip reaction progress are provided to a processor for measuring the analyte.

Abstract: A method of making strip for testing for the presence of an analyte generally comprises providing a support member which includes a spreading layer and a reagent layer, and a capillary in communication with the support layer and spreading layer for transporting a sample of body fluid thereto.

Abstract: An electrochemical test device is provided for determining the presence or concentration of an analyte in an aqueous fluid sample. The electrochemical test device includes a working electrode and a counter electrode made of an amorphous semiconductor material. The working electrode is overlaid with a reagent capable of reacting with an analyte to produce a measurable change in potential which can be correlated to the concentration of the analyte in the fluid sample. The test device optionally contains a reference electrode made of an amorphous semiconductor material having a reference material on the reference electrode.

Abstract: A strip for testing for the presence of an analyte generally comprises a support member which contains a spreading layer and a reagent layer, and a capillary tube in communication with the support layer and spreading layer for transporting a sample of body fluid thereto. A method of testing a fluid for the presence or concentration of an analyte is also provided which generally includes providing a test strip with a support member, a spreading layer, and a reagent layer on the spreading layer. A capillary tube is provided on the support member whereby a fluid containing an analyte to be tested is introduced into the tube and flows through the tube to the spreading layer and contacts the reagent layer.

Abstract: An electrochemical test device is provided for determining the presence or concentration of an analyte in an aqueous fluid sample. The electrochemical test device includes a working electrode and a counter electrode made of an amorphous semiconductor material. The working electrode is overlaid with a reagent capable of reacting with an analyte to produce a measurable change in potential which can be correlated to the concentration of the analyte in the fluid sample. The test device optionally contains a reference electrode made of an amorphous semiconductor material having a reference material on the reference electrode.

Abstract: A dry chemistry reagent matrix composition is provided containing a matrix material and a reagent composition containing 3-methyl-6(sulfonate salt)-benzothiazolinone-(2)-hydrazone (MBTH-S), N-ethyl-N-(3-sulfopropyl)aniline, and an oxidase enzyme or a peroxidase enzyme or a mixture thereof. The dry chemistry reagent matrix composition is useful in reagent test strips for determining the presence or concentration of an analyte in a fluid sample, such as blood.

Abstract: An electrochemical test device is provided for determining the presence or concentration of an analyte in an aqueous fluid sample. The electrochemical test device includes a working electrode and a counter electrode made of an amorphous semiconductor material. The working electrode is overlaid with a reagent capable of reacting with an analyte to produce a measurable change in potential which can be correlated to the concentration of the analyte in the fluid sample. The test device optionally contains a reference electrode made of an amorphous semiconductor material having a reference material on the reference electrode.

Abstract: A strip for testing for the presence of an analyte generally comprises a support member which contains a spreading layer and a reagent layer, and a capillary tube in communication with the support layer and spreading layer for transporting a sample of body fluid thereto. A method of testing a fluid for the presence or concentration of an analyte is also provided which generally includes providing a test strip with a support member, a spreading layer, and a reagent layer on the spreading layer. A capillary tube is provided on the support member whereby a fluid containing an analyte to be tested is introduced into the tube and flows through the tube to the spreading layer and contacts the reagent layer.

Abstract: Processes are provided for removal of cells as cell pellets from liquid milk samples, or from cultures or extracts of other food materials or other materials of biological origin. The concentrated cells in the pellet can be analyzed by various techniques to determine the relative cell count, such as by lysing of the cells followed by measurement of ATP. Nucleic amplification, as by the polymerase chain reaction method, can be carried out using the cellular pellet directly, without need for isolation of nucleic acid from the cells. After the amplification, an assay can be carried out for amplified nucleic acid segment indicative of the presence of cells of interest in the sample. The invention thus provides methods for obtaining cellular components from samples of milk, and cultures or extracts of other materials, including food materials, and for determining relative contamination of milk and such other materials by microorganisms. The invention also provides kits for carrying out its various methods.

Abstract: Processes are provided for removal of cells as cell pellets from liquid milk samples, or from cultures or extracts of other food materials or other materials of biological origin. The concentrated cells in the pellet can be analyzed by various techniques to determine the relative cell count, such as by lysing of the cells followed by measurement of ATP. Nucleic amplification, as by the polymerase chain reaction method, can be carried out using the cellular pellet directly, without need for isolation of nucleic acid from the cells. After the amplification, an assay can be carried out for amplified nucleic acid segment indicative of the presence of cells of interest in the sample. The invention thus provides methods for obtaining cellular components from samples of milk, and cultures or extracts of other materials, including food materials, and for determining relative contamination of milk and such other materials by microorganisms. The invention also provides kits for carrying out its various methods.

Abstract: There is disclosed an oligonucleotide strand or duplex-targeting protein conjugate, a linking group to link an oligonucleotide to a targeting protein, and a method for producing targeting protein conjugates containing oligonucleotide strands or duplexes. A suitable linker is a bifunctional phosphoramidite ester that binds to both the targeting protein and the oligonucleotide strand or duplex. The invention can be used for delivering chemotherapeutic agents to target sites based upon the specificity of the targeting protein and to deliver specific oligonucleotide sequences to a target site to hybridize and inhibit the expression of complementary sequences within the target cell genome.