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: 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: A test strip for use in determining the presence or concentration of an analyte in whole blood is disclosed. The test strip is a porous membrane having disposed thereon (a) a separating agent capable of separating from whole blood, red blood cells and a fluid component substantially free of red blood cells; (b) an indicating reagent system capable of indicating the presence or concentration of an analyte in the fluid component by producing a spectrophotometric change upon contact with the fluid component; and (c) an opaque filler capable of reducing spectrophotometric interference caused by the presence of the red blood cells. Also disclosed are methods of testing whole blood for the presence or concentration of an analyte using the test strip.

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: A ribbon-like flat web having a plurality of side by side depressions is fed through a horizontal slot having a downward facing surface having an aperture communicating with a reservoir of reagent containing solution. The web is urged against the downward facing surface to provide sealing as the solution is fed into the upward facing depressions. The aperture communicating with the reservoir is profiled as a parallelogram having a leading edge which is oblique to the direction of movement. After emerging from the dispensing apparatus the exposed solution is dried in hot air, followed by spray application of a second solution, further drying in hot air, and application of a backing to form capillary chambers. The method is especially useful for manufacturing coagulation assays having magnetic particles and thromboplastin.

Abstract: On a carrier layer there are arranged several test layers which are at least partly in fluid contact with one another, enabling liquid exchange. On the carrier layer are arranged an application zone, a detection zone for the production of a detectable signal characteristic of the analytical determination, which contains at least one said test layer which is a reaction layer, and an absorption zone with a test layer which is an absorptive layer of an absorbent material, wherein the reaction layer and absorption zone are positioned next to each other. Between the application and the absorption zone is a capillary-active transport path on the carrier layer which connects the application zone and the absorption zone. The reaction layer is arranged parallel to the transport path between the application zone and the absorption zone in such a manner that it is in liquid contact with a liquid transported in the transport path.

Abstract: An apparatus useful in analyzing samples, such as body fluids, is presented. The device is especially useful in analyzing whole blood because its configuration, with a differential vertical dimension permits rapid flow and uniform draw through the device, with contact of the relevant portion of the sample to a reagent means. Also disclosed is a method for analyzing a sample using the device.