Abstract: A lancet or finger-stick device operable to make a small incision into the vascular tissue of the skin to induce a controllable blood flow is particularly suited for incisions of the finger-tip of a patient. The device and method provide multiple use by a single-user in that the device provides an autologous re-use feature, such that an individual can reset and reuse the device on the same patient in case of an accidental misfire prior to actual use or if the first incision does not provide a sufficient blood sample. A disabling mechanism which the individual performs immediately prior to disposal of the used device is incorporated into the invention. These features permit the user of a consumer self-test or professional-use test to re-stick an individual's fingertip in the event that the first try is unsuccessful or the blood flow is inadequate.

Abstract: Methods and devices are provided for carrying out assays with minimal technical training where quantitative visual determinations may be made. The devices provide for a flow-path where a sample receiving element is moved from a sample receiving position to a position where it serves to bridge a transport element and a measurement element, so that the sample may be transported from the sample element to the measurement region. Labelled conjugates are provided which migrate a distance into the measurement region related to the amount of analyte in the sample.

Abstract: A laminated assay device for use in determining the presence or amount of an analyte in a sample involving a bibulous assay strip having a sample application zone, a reagent zone and a pair of liquid impervious barriers defining a measurement zone extending from and in fluid communication with the application zone. The measurement zone has a volume measuring the amount of sample required for the assay. A substantially nonabsorbent first supporting film extends across and is laminated to the front surface of the assay strip, while a substantially nonabsorbent second supporting film extends across and is laminated to the back surface of the assay strip. The assay strip is impregnated with the members of a signal producing system which, upon reaction with a component in the sample, produce a detectable signal.

Abstract: Systems are provided for the detection of hydrogen peroxide for determination of analytes, where a N-alkylated 3-oxyaniline derivative is covalently bonded to a bibulous support and the other component for forming an indamine dye may be non-covalently bound to the support. Upon passage of a transport medium across the support in the presence of hydrogen peroxide and a peroxidase, an indamine dye is formed. Where a limited amount of hydrogen peroxide is introduced at a site proximal to one end of the support, and the hydrogen peroxide migrates toward the other end, the distance of color development will be related to the amount of hydrogen peroxide, which can be correlated to the amount of analyte in a sample.

Abstract: An assay for determining the cholesterol level in a sample involving a bibulous strip comprising a transfer region for transporting a transport medium from a transport medium source, a sample receiving region in fluid communication with the transfer region, and a measurement region in fluid communication with the sample receiving region, and a detectable signal reagent system comprising a catalytic agent or enzyme, unbound conversion reagent and bound reagent wherein the conversion reagent reacts with cholesterol to form an intermediate product and wherein the bound reagent reacts with the intermediate product in the presence of the catalytic agent or enzyme to produce a detectable border, in which the conversion reagent is placed in the transfer region of the strip or in a region of the strip between the sample receiving and measurement regions and the signal reagent is non-diffusively bound to the strip in the measurement region, and which upon contact with the sample and the transport medium results in the

Abstract: Non-instrumented assays are providing employing a flow-path with a moveable sample receiving pad, which moves from a sample receiving site to a bridging site between a transport element and a measurement region. A reagent transport solution is employed which comprises enzymes capable of reacting with the analyte to produce hydrogen peroxide, where horseradish peroxidase may catalyze a reaction resulting in the formation of a detectable boundary in the measurement region. The distance of the boundary is indicative of the amount of analyte in a sample.

Abstract: Improved self-contained automated assay devices are provided which allow for reliable release of eluent solution upon opening of a pouch with scoring teeth, so that the solution is transferred to a well for carrying out the assay. The improvements comprise using a bibulous member which is moved into the pouch to initiate eluent solution transport or providing for a sudden shock to the solution to initiate flow.

Abstract: Constructions are provided for removing interfering red blood cells from a blood sample and providing a measured amount of serum or plasma to a pad. The pad serves as a bridge for the transfer of reagent between two bibulous strips, resulting in transfer of reagent solution through the pad and transport of a material to be measured to the measuring region of the strips. Particularly, glass fiber membranes are used in conjunction with cellulosic membranes to minimize red blood cell lysis, remove red blood cells and provide a measured amount of sample.

Abstract: A self-contained assay device is provided, where an analyte may be detected or be quantitated by measuring the distance of a detectable signal from a predetermined site. The device employs two strips separated by a gap, where a flow path is completed by movement of a sample receiving pad into the gap. The movement of the sample receiving pad also results in release of a reagent solution which is then transported through the pad into the quantitation area where the amount of analyte may be determined. Various chemistries may be employed for providing a detectable signal.