Abstract: A package is provided with a lid and container that are heat sealed together. A multi-ply sheet material is provided for being thermoformed to define the container which has a tapering wall and bulge-resistant bottom end. Prior to thermoforming the container from the sheet, the sheet is heated with oval pads on a plurality of plates which are arranged in a configuration to facilitate control of the sheet temperature. A plug is used in the thermoforming process to contact the sheet and position the sheet within a die. A lid sheet is heat sealed to the container sheet over the thermoformed containers so as to produce a pair of spaced-apart, annular bead heat seals. The package is completed by severing the sealed-together sheets at the periphery of the container with a punch and die set that produces and clean, smooth cut surface.

Abstract: Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of: (a) forming an unobstructed opening in the area of the skin from which the sample of blood is to be extracted; and (b) extracting the sample of blood from the unobstructed opening in the skin, with the aid of a vacuum and a stretching of the skin. In another aspect of the invention, an apparatus for carrying out the method described previously is provided. The apparatus comprises: (a) a device for forming an unobstructed opening in an area of skin from which said sample is to be extracted, preferably a lancing assembly; and (b) a vacuum pump. Preferably, the apparatus also includes a housing.

Abstract: Unit-of-use reagent compositions and methods for preparing such reagent compositions are disclosed. The reagent composition comprises one or more reagents which are necessary for a specific binding assay and which are incorporated in a porous material which is encapsulated in a carrier matrix. The unit-of-use reagent composition can be lyophilized to avoid the need for cold storage of the reagent composition.

Abstract: Provided are microparticle forms of carbon, carbon catalysts and carbon-containing electrically conductive materials which are covalently linked to peroxidase. The carbon:peroxidase conjugates are suitable for use as substrates in conventional electrodes. Surprisingly, the conjugates display very little sensitivity to known interfering substances and thus are suitable for use as interference free electrodes.

Abstract: Dosage form unit is provided to deliver one or more beneficial agents into a fluid, such as liquid enteral nutritional product. The dosage form unit includes a core containing at least one beneficial agent, preferably a marker dye, which is dispersible in the fluid. The core also contains a compatible binding agent to bind the beneficial agent together. Additional components of the core may include a plasticizer, a standard flow agent, a lubricant, additional tableting aids and at least one hydrophilic agent. A latex coating encases the core. The latex coating includes a mixture containing a substantially hydrophobic base material, preferably formed from an emulsion of cellulose acetate microspheres, which is capable of defining a matrix-type membrane, and at least one hydrophilic component being dispersible in the fluid. A dispersible beneficial agent is preferred as one of the hydrophilic components of the latex coating to allow immediate release of the beneficial agent therefrom.

Abstract: A method for increasing the permeability of the stratum corneum by means of a source of light, preferably a laser, more preferably a pulsed laser. By increasing the permeability of the stratum corneum, access to the interstitial fluid is achieved, thereby enabling measurement of analytes in the interstitial fluid. In one aspect, the method comprises the steps of: (a) providing a source of light having a wavelength of from about 930 nm to about 1040 nm; and (b) exposing a region of the stratum corneum of the patient to said source of light for a period of time sufficient to form an opening in the stratum corneum.

Abstract: A method for determining the concentration of an analyte in a biological sample comprising the steps of: (1) providing an optical measuring instrument that comprises at least one thermally controllable optical measuring element that comes into contact with the surface of the biological sample; (2) applying an inert, thermally conductive, optically transparent coupling agent to the at least one optical measuring element or to the surface of the biological sample or both so that the coupling agent will be disposed at the interface of the surface of the biological sample and the at least one optical measuring element; (3) measuring optical properties of the biological sample by means of the optical measuring instrument; and (4) correlating the optical properties of the biological sample with the concentration of the analyte in the biological sample. A coupling agent suitable for this invention must have several properties to enable it to help decrease measurement variation, especially drift.

Abstract: Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of: (a) forming an unobstructed opening in the area of the skin from which the sample of blood is to be extracted; and (b) extracting the sample of blood from the unobstructed opening in the skin, with the aid of a vacuum and a stretching of the skin. In another aspect of the invention, an apparatus for carrying out the method described previously is provided. The apparatus comprises: (a) a device for forming an unobstructed opening in an area of skin from which said sample is to be extracted, preferably a lancing assembly; and (b) a vacuum pump. Preferably, the apparatus also includes a housing. In another aspect of this invention, an article is provided for an article capable of both collecting blood and detecting an analyte in that blood is provided.

Abstract: A method and kit for measurement of a steroid by means of a competitive immunoassay, preferably a competitive enzyme immunoassay. The method and kit involve the use of a steroid analogue conjugated to a label. The steroids that are amenable to detection by the method and kit of the present invention include estradiol and progesterone. The method comprises the steps of: a. incubating a mixture of a test sample suspected of containing a given steroid, a solid phase coupled to an antibody specific for that steroid, and a conjugate of an analogue of that steroid to form steroid/antibody complexes and conjugate/antibody complexes on said solid phase; b. separating said solid phase from said mixture; c. measuring the amount of label present in said mixture or in said solid phase; and d. determining the amount of steroid in said sample from the amount of label. The kit comprises a solid phase coupled to an antibody specific for a steroid and a conjugate of an analogue of that steroid.

Abstract: A sample container segment assembly for use in an automated, continuous, and random access analytical system is disclosed. The assembly includes a sample container which is received by a sample container segment, and the sample container segment is received on a carousel of the automated analytical instrument. The test sample container includes an upper skirt and a body having a reservoir for receipt of the test sample. The segment includes a base, a frame, and a handle. The frame has a shelf for which the upper skirt of the test sample container rests on, and has openings for receipt of the body of the sample container. The carousel has a carousel trough for receipt of the base of the sample container segment, and has a plurality of alignment pins disposed in the carousel trough. The base of the sample container segment has a circular slot and an elongated slot for receiving the alignment pins and positioning the sample container segment relative to the carousel.

Abstract: This invention provides a method, a reagent, and a kit for detecting herpesvirus-specific IgM antibodies indicative of recent infection while preventing detection of low levels of herpesvirus-specific IgM antibodies present in individuals of low risk. The invention also provides a reagent for use in detecting herpesvirus-specific IgM antibodies indicative of recent infection while preventing detection of low levels of herpesvirus-specific IgM antibodies present in individuals of low risk.

Abstract: The invention features a novel method of assaying glycated hemoglobin (GHb) in a sample using a capture molecule that binds GHb and hemoglobin (Hb), and detecting bound GHb with a molecule that distinguishes GHb from non-glycated hemoglobin (Hb). The molecule used to distinguish GHb from Hb may be an antibody. The assay and antibodies of the invention are useful for the evaluation of GHb in disease states such as diabetes.

Abstract: A method and apparatus for obtaining a sample of interstitial fluid from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of (a) treating an area of the skin with vacuum or heat or both vacuum and heat to increase the availability of interstitial fluid at that area of the skin; (b) forming an opening in the treated area of the skin; and (c) extracting the sample of interstitial fluid from the opening in the skin, with the aid of vacuum and stretching of the skin. In another aspect of the invention, an apparatus for carrying out the method described previously is provided. Th apparatus comprises (a) a device for forming an unobstructed opening in the area of the skin from which the sample is to be extracted, preferably a lancing assembly; and (b) a vacuum pump. Preferably, the apparatus also includes a housing.

Abstract: An electrochemical sensor electrode strip that measures analyte concentration in an aqueous sample as small as 2.5 to 2.0 .mu.L is described. Reduction in the minimum sample size is achieved by means of a dielectric coating impregnated into peripheral regions of one or more hydrophilic mesh layers, thereby reducing sample dead volume. The mesh layers are located between an electrode support and a cover layer, which cover layer includes an aperture located upstream from an electrode arrangement.

Abstract: A method for determining concentration of an analyte in a biological sample comprising the steps of:(a) combining the biological sample, at least one oxidizing enzyme for the analyte of interest, nicotinamide adenine dinucleotide (hereinafter NAD.sup.+), and a chemiluminescent label to form a reaction mixture;(b) allowing the analyte to undergo an oxidation-reduction reaction and NAD.sup.+ to be converted to the reduced form of nicotinamide adenine dinucleotide (hereinafter NADH) and further allowing the chemiluminescent label to react with NADH; and(c) determining the concentration of the analyte of interest in the biological sample by correlating the quantity of light emitted with the concentration of NADH.

Abstract: Apparatus and method for simultaneously performing at least two assays using certain reagents for a plurality of liquid samples on a continuous analytical system is disclosed. The method comprising the steps of combining an aliquot of each liquid sample with at least one reagent in a first reaction container to form a first assay reaction for each liquid sample, and combining an aliquot of each liquid sample with at least one of the other reagents in a second reaction container to form a second assay reaction for each liquid sample. The method further comprises the steps of incubating the assay reactions of each assay being conducted at least one time, and performing other activities associated with each assay and using the first and second assay reactions to complete each assay, including analyzing the incubated assay reactions.

Abstract: Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of:(a) placing a blood collection device over a region on the surface of the skin from which said sample is to be obtained,(b) forming a seal between said blood collection device and said surface of the skin,(c) creating a vacuum sufficient to result in said surface of the skin becoming stretched and engorged with blood,(d) triggering a lancing assembly and causing a lancet to penetrate said skin,(e) retracting said lancet,(f) withdrawing blood toward and onto a fluid collector, and(g) releasing the vacuum.In another aspect of the invention, an apparatus for carrying out the method described previously is provided.

Abstract: Apparatus and method for determining at least one parameter, e. g., concentration, of at least one analyte, e. g., urea, of a biological sample, e.g, urine. A biological sample particularly suitable for the apparatus and method of this invention is urine. In general, spectroscopic measurements can be used to quantify the concentrations of one or more analytes in a biological sample. In order to obtain concentration values of certain analytes, such as hemoglobin and bilirubin, visible light absorption spectroscopy can be used. In order to obtain concentration values of other analytes, such as urea, creatinine, glucose, ketones, and protein, infrared light absorption spectroscopy can be used. The apparatus and method of this invention utilize one or more mathematical techniques to improve the accuracy of measurement of parameters of analytes in a biological sample.

Abstract: An article and a method for monitoring the concentration of glucose in blood. In one aspect, the invention involves an article comprising a multiple-layer element utilizing reagents capable of reacting with an analyte of interest. In a preferred embodiment, the element comprises:(a) a core layer having two major surfaces, an optical reading chamber extending from a first opening in one of the two major surfaces to a second opening in the other of the two major surfaces, the core layer further having a third opening therein and a flow channel, one end of which flow channel communicates with the third opening and the other end of which flow channel communicates with the optical reading chamber;(b) a base layer in face-to-face contact with one major surface of the core layer; and(c) a cover layer in face-to-face contact with the other major surface of the core layer, the cover layer having an opening therein to vent the element.