Abstract: It has been discovered that the use of a substantially free-standing voice coil within a lancing device in coordination and combination with a stationary magnet and electronic circuit renders a much improved lancing device. The minimal weight of the free standing voice coil and the attractive forces of the magnet allow the battery-powered electronic circuit to maintain excellent control over the advancement and retraction of a lancet. When the electronic lancing device is initiated by a user, the voltage source within the electronic lancing device provides sufficient current through the voice coil such that the coil and lancet are repulsed from the magnet and propelled into the puncture site.

Abstract: Disclosed is a dry assay device for carrying out immunochromatographic assays. The device involves an assay strip contained in the interior of a plastic cassette along with a thermally conductive material in thermal communication with the assay strip to more rapidly bring the strip's temperature to that of the ambient.

Abstract: A fixed volume liquid transfer device defined by a small bore tube having an open end for collection of liquids and a plunger in the tube is disclosed. A piston is mounted around the open end and an air plug is mounted in the piston adjacent the open end. Liquid in a test tube is transferred to a testing site by inserting the transfer device into the test tube. As the piston contacts the liquid, the liquid is pumped into the tube. As the transfer device is inserted further, the air plug is actuated to balance air pressure across the piston. The device may then be withdrawn from the test tube and transported to a test site. At the test site, the plunger is depressed to expel the liquid into a testing device.

Abstract: An improved test strip for determining the presence or concentration of unknown or a constituent in a liquid test sample is disclosed. The test strip comprises a support strip and a test pad, wherein the test pad includes a carrier matrix incorporating a reagent composition capable of interacting with the constituent of interest to produce a detectable or measurable response. The test strip further comprises an infrared dye, applied either to the support strip or incorporated into a test pad, which ensures proper alignment of the test strip in an apparatus having a detection system for the detectable or measurable response. The improved test strip reduces the number of erroneous assays for the constituent of interest.

Abstract: Disclosed is an improved method for determining the concentration of a first analyte in a fluid test sample as a function of a second analyte also present in the sample whose concentration in the fluid sample is clinically related to that of the first analyte. The method involves determining the concentration of the first analyte, and, if this concentration is outside of its useful analytical range, dividing this concentration by the normal concentration of the second analyte. This method of ratioing the concentrations of the first and second analyte is advantageous because accuracy is increased with fewer false positive and false negative results being reported.

Abstract: An apparatus for automatically detecting the presence of a reagent strip (14) having a body fluid sample disposed thereon and for inspecting the reagent strip (14) after the presence of the reagent strip (14) is detected is provided with a detection system adapted to automatically detect the presence of a reagent strip (14) at a reagent strip receiving area (12), a light source (64 or 68) adapted to illuminate the reagent strip (14) after the presence of the reagent strip (14) at the reagent strip receiving area (12) is detected, and a detector (66 or 70) adapted to receive light from the reagent strip (14) when the reagent strip (14) is being illuminated by the light source.

Abstract: A method and apparatus are provided for data management authentication in a clinical analyzer. The clinical analyzer includes a sensor for receiving a user sample to be measured and a processor for performing a predefined test sequence for measuring a predefined parameter value. A memory is coupled to the processor for storing predefined parameter data values. An authentication password is associated with each data transmission by the clinical analyzer and read by an associated computer system to validate each data transmission. The authentication password is generated by the clinical analyzer utilizing predetermined information in each data transfer.

Abstract: An apparatus in accordance with the invention is directed to an optical inspection apparatus (10) adapted to inspect a liquid sample. The apparatus includes a tray (20) that is adapted to be physically coupled to a first liquid sample carrier (22) and a second liquid sample carrier (40), each of the first and second liquid sample carriers (22, 40) being adapted to hold a liquid sample. The first liquid sample carrier (22) is of a first type and the second liquid sample carrier (40) is of a second type different from the first type. The apparatus (10) has a light source (108) adapted to illuminate one of the liquid samples associated with one of the liquid sample carriers (22 or 40) when the liquid sample carrier (22 or 40) is coupled to the tray (20) at an inspection location and a detector (110) adapted to receive light from the liquid sample when the liquid sample is being illuminated by the light source (108).

Abstract: Disclosed is an assay for an analyte in a fluid test sample such as urine which involves combining the fluid test sample with a reagent system comprising an apo-peroxidase, a redox dye, a peroxide and a metal porphyrin which is bound to an analyte/analyte specific binding partner which complex has a combined molecular weight of at least about 180 K Daltons. When this conjugate interacts with analyte in the fluid test sample, a portion of the specific binding partner is dissociated from the complex thereby enabling the metal porphyrin to reconstitute with the apo-peroxidase. The reconstituted peroxidase can interact with the peroxide and redox dye to provide a colored response to analyte in the fluid test sample.

Abstract: Disclosed is a method for the immobilization of an analyte such as deoxypyridinium (DPD) onto a solid support. The method involves binding an antigen-amino acid-deoxypyridinium complex to the support via an anti-antigen binding partner located in a capture zone of the solid support. Preferably, the support is nitrocellulose and the antigen has the fluorescein structure.

Abstract: Disclosed is an improved method for the detection of creatinine in a fluid test sample by contacting the test sample with cupric ions, a hydroperoxide, citrate and an oxidizable dye which gives a colored response in the presence of oxygen free radicals and a pseudoperoxide. The improvement involves stabilizing the reagent formulation by the addition thereto of an ionizable phosphate containing compound such as phytic acid.

Abstract: The present invention provides a device and a process for detecting an analyte in a biological fluid. The device comprises a separating matrix for separating analyte from the fluid and means for detecting the analyte, where the separating matrix contains HEPES buffer, preferably in an amount between 70 and 150 millimolar. The process comprises applying the sample to the device having a separating matrix and then detecting analyte in the sample using the detection means. The presence of HEPES in the separation layer shortened the detection time.

Abstract: Disclosed is a diagnostic device for the colorimetric detection of an analyte in a test fluid. The device is a dry reagent layer which is overcoated with a transparent, fluid permeable membrane. The membrane is made up of a combination of a water dispersible and a water soluble polymer. The membrane may contain a surfactant and a thickener.

Abstract: An apparatus adapted to inspect reagent strips having fluid samples, such as urine samples, disposed thereon and to reduce the likelihood of contamination of one of the fluid samples with another of the fluid samples is provided with a reagent strip support (22) adapted to support a reagent strip (14) having a plurality of reagent pads (26) disposed in a longitudinal direction along the reagent strip (26), including reagent pad which has a reagent sensitive to contamination.

Abstract: Disclosed is a method for determining the concentration of an analyte in a fluid test medium by use of an immunochromatographic test strip through which the test fluid can flow by capillarity. The test strip has at least two capture bands and optionally one or more collection bands which capture labeled anti-analyte antibody to provide a detectable signal. The signals from the label is quantitatively detected in each of the bands to provide a pattern of signals which is unique to the concentration of analyte in the test fluid. The pattern of signals are mathematically combined to create a monotonous dose-response curve to thereby factor out the high analyte hook effect which can be present in this type of assay.

Abstract: An apparatus for inspecting a reagent strip (14) having a fluid sample disposed thereon is provided with a conveyor system (80) adapted to move the reagent strip (14) from a first reagent strip inspection location to a second reagent strip inspection location, a first readhead (60) associated with the first reagent strip inspection location, and a second readhead (62) associated with the second reagent strip inspection location. Each of the readheads (60, 62) has a light source (64, 68) and a light detector (66, 70) associated therewith, each light source (64, 68) being adapted to illuminate the reagent strip (14) at one of the reagent strip inspection locations and each light detector (66, 70) being adapted to detect light from the reagent strip (14) when the reagent strip (14) is disposed at one of the reagent strip inspection locations.

Abstract: Disclosed is a device and method for carrying out an assay for an analyte in a fluid test sample by immunochromatography. The device involves a strip having a non-porous receiving member of a hydrophobic material in direct fluid communication with a reagent region of an absorbent material through which the fluid test sample can flow by capillarity. By applying the fluid test sample to the non-porous hydrophobic receiving member rather than directly to the absorbent material the reliability of the assay is enhanced.

Abstract: A vacuum assisted lancing device (10) for obtaining capillary blood from body sites includes a plunger (12) mounted in a barrel or upper housing (24) that upon being pressed by a user, drives a lancet (18) to puncture skin at a body site. A vacuum member such as a diaphragm (38, 66) or bellows (66) is displaced by the plunger (12) and displaces air in the lancing device (10) to create a vacuum. The vacuum draws skin partially into the lancing device (10) causing blood to form at the puncture. The vacuum is then released and the blood is tested.

Abstract: The present invention provides a device and a process for detecting an analyte in a biological fluid. That device comprises a cover portion with a restricted area for sample application, a separation matrix for separation of the analyte from substances in the sample that can interfere with detection of the analyte and means for detecting the analyte. The restricted area of sample application is less than 90 percent of the cross-sectional area of the separation matrix and the separation matrix and the means for detecting analyte are under compression of between 14 to 43 percent. A process comprises applying a sample of fluid to such a device and detecting a signal generated from an interaction between the analyte and the detection means in the device.

Abstract: The present invention involves an improvement to an assay for the activity of a metal chelate, such as copper II/creatinine, which activity is related to the concentration of the analyte in a fluid test sample. In carrying out the assay, there is combined the fluid test sample, the metal chelate or precursors thereof, a hydroperoxide, an oxidizable indicator and a pyrazole derivative which inhibits the ability of hemoglobin to oxidize the oxidizable dye.