Abstract: Surface-enhanced spectroscopy for quantitative analysis of analytes in biological liquid samples. A device for testing a biological liquid sample for the presence or concentration of an analyte includes: (a) a substrate defining a surface which has electrically conductive particles disposed thereon, wherein the surface is adapted to accommodate the liquid sample; (b) means for generating radiation and directing the radiation to be incident on said surface of the substrate so that radiation is emitted from the electrically conductive particles; and (c) means for detecting the emitted radiation. In another embodiment a matrix having electrically conductive particles that are incorporated in the matrix or that are disposed on a surface thereof, wherein the matrix is permeable to the liquid biological sample is used in place of the substrate. The device is particularly suited for determining glucose in human whole blood.

Abstract: A disposable lancing element is adapted for use in a lancing device for making an incision through a user's skin. The lancing element includes a body which defines a longitudinal axis, and has a skin-lancing member projecting from a front end thereof. A capillary tube is mounted in the body in laterally spaced relationship to the skin-lancing member and is slidable longitudinally relative to the body so as to be extended forwardly past the skin-lancing member. The body includes a plurality of circumferentially spaced, radially outwardly projecting bosses formed thereon for guiding the disposable element installation in a carrier element. The skin-lancing member may comprise a plurality of needles or barbs arranged in parallel side-by-side relationship. In lieu of a skin-lancing member, the disposable element may possess a longitudinal through-hole for conducting a skin-piercing laser light beam or pressurized fluid. A capillary tube may have an outwardly flared lower (inlet) end.

Abstract: The invention provides a method for measuring the amount of analyte in a sample of biological fluid using a simple low sample volume reagent test strip with a built in metering system. The test strip may include a microtitration zone to prevent oversampling and an integrated capillary to prevent problems associated with short sampling and act as means of absorbing the fluid sample. The test strip comprises a wicking layer and a reaction matrix embossed layer in the form of a pillow assembled into a microtitration pocket formed in the strip. The test strip is used in single use applications such as the determination of the concentration of glucose in blood.

Abstract: This invention provides methods and apparatus for applying a reagent to an analytical test device. The methods and apparatus employ a nozzle and a flexible restrictor to accurate control the amount of reagent applied to the test device. The analytical test devices prepared by the methods of this invention are used to determine the presence or the quantity of an analyte in a liquid sample, such as whole blood.

Abstract: An analyte detection system is provided with calibration information uniquely specific to the set of test strips to which the sample is to be applied. The calibration information may be stored in permanent memory of the testing device, such that the device is discarded after use of all the test strips in a kit, or it may be stored in a calibration chip accompanying the set of test strips and distributed therewith, thereby enabling re-use of the testing device with a different set of test strips and associated calibration chip.

Abstract: A sampling device for sampling body fluid includes a lancet for making an incision, a capillary tube for drawing-up body fluid from the incision, and a test strip affixed to an upper end of the capillary tube for receiving the fluid. An absorbent pad can be disposed between the test strip and capillary tube for spreading-out the fluid being transferred to the test strip. An on-site analyzer such as an optical analyzer and/or an electrochemical analyzer can be mounted in the device for analyzing the fluid. Alternatively, a test strip can be slid through a slot formed in the bottom end of the device so that by passing the device against the skin after an incision has been formed, the test strip will directly contact body fluid emanating from the incision.

Abstract: A sampling device for sampling body fluid includes a casing which is pressed against a skin surface to produce a seal therewith. A cocking mechanism is pulled rearwardly to place a lancing device in a cocked state. By releasing a trigger, the lancing device is driven forward to produce an incision in the skin, and then is retracted out of the incision. A plunger mounted on the cocking mechanism is then retracted to generate a negative pressure at the front end of the casing to draw body fluid from the incision.

Abstract: A sample of a body fluid such as blood or interstitial fluid is obtained from a body by lancing a portion of a user's skin, preferably in an area other than a finger tip, to form an incision. After the needle has been removed from the incision, a force is applied to depress the skin in a manner forming a ring of depressed body tissue in surrounding relationship to the incision, causing the incision to bulge and the sides of the incision to open, whereby body fluid is forced out through the opening of the incision. A stimulator member is mounted to an end of a lancet-carrying housing for applying the force. The stimulator member can be movable relative to the housing, and can be either heated or vibrated to promote movement of the body fluid.

Abstract: Body fluid is sampled from a skin incision by placing a ring against the skin and repeatedly applying an elastic pressing force to the ring, whereby a stimulator surface of the ring depresses a ring of skin and body tissue in surrounding relationship to the incision to force body fluid from the incision. The stimulator surface is inclined at an angle of 10 to 65 degrees; a width of the stimulator surface is from 5 mm to 20 mm, and an inner diameter of the stimulator surface is no less than 6.0 mm.

Abstract: A device for sampling body fluid includes a housing having a sleeve at a forward end thereof which is displaceable in response to being pressed against a user's skin to trigger the firing of a lancet. After the lancet is removed from the incision, the sleeve is repeatedly pressed against the skin to depress a ring of body tissue in surrounding relationship to the incision to express body fluid outwardly through the incision. A pusher member is then actuated to push a capillary tube through a front end of the housing for drawing-in body fluid. The lancet is a disposable lancet which includes a body supporting a skin-lancing member and the capillary tube. The disposable lancet passes through an upper end of a lancet carrier when being installed or removed. The device cannot be armed until the disposable lancet is installed in the housing, because the capillary tube functions to push a safety device to a non-safety position.