Abstract: A reagent is suitable for measuring the concentration of an analyte in a hemoglobin-containing biological fluid, such as whole blood. The reagent comprises dehydrogenase enzyme that has specificity for the analyte, NAD, an NAD derivative, pyrrolo-quinoline quinone (PQQ), or a PQQ derivative, a tetrazolium dye precursor, a diaphorase enzyme or an analog thereof, and a nitrite salt. The reagent causes dye formation that is a measure of the analyte concentration. The nitrite salt suppresses interfering dye formation caused non-enzymatically by the hemoglobin. Preferably, the reagent is used in a dry strip for measuring ketone bodies, such as beta-hydroxybutyrate.

Abstract: A lancing device has a spring-loaded lancet holder slidably mounted within a housing for carrying a disposable lancet and needle. A slider mounted in a slot in the housing is moved back for cocking the device and, after the lancet is fired, is moved forward to eject the used lancet. A releasable connector reversibly immobilizes the holder while the lancet is being ejected. The releasable connector permits a shortened ejection stroke, which, in turn, permits a shorter slot in the housing.

Abstract: An electrochemical assay includes a method for determining with great accuracy the time at which an applied sample bridges a gap between the electrodes of an electrochemical cell. The method involves applying a constant small current across the gap, while monitoring the potential difference between the electrodes. The time at which the sample bridges the gap is marked by a sharp drop in the potential. A constant voltage is applied after the sample is detected, and the current and/or charge through the sample is monitored over a period of time. From the measured current or charge, the analyte concentration of interest can be calculated.

Abstract: A dry phase reagent test strip for measuring the concentration of an analyte in a biological fluid includes a colored indicator whose hue indicates a calibration of the strip. Preferably, the test strip measures the concentration of glucose in whole blood.

Abstract: A tamper-evident closure seal is imprinted on its top surface to form a pattern of adjoining matte and high-gloss areas. The bottom surface of the seal is coated with a permanent adhesive. The seal may be used to bridge a gap between two perpendicular surfaces of a carton. If unauthorized entry to the carton is gained by cutting the seal along the gap, that entry can be detected even if the carton is resealed by overlapping the closure seal in register with a transparent seal of the same size and shape. The unauthorized entry will be evident, because the pattern on the original closure seal will not be visible through the overlaid transparent seal.

Abstract: Stable oil-in-water emulsions are prepared by mixing oil, water and an insoluble protein at high shear. By varying the amount of insoluble protein the emulsions may be made liquid, semisolid or solid. The preferred insoluble proteins are insoluble fibrous proteins such as collagen. The emulsions may be medicated with hydrophilic or hydrophobic pharmacologically active agents and are useful as or in wound dressings or ointments.

Abstract: A hollow, frustum-shaped disposable device is used in an apparatus for measuring the concentration of an analyte in a sample of a biological fluid. The smaller end of the frustum has a porous membrane, to which a sample of the fluid may be applied. Preferably, a reagent in the membrane reacts with the analyte to cause a color change. The device is mounted on a meter, which measures the color change and computes from the change the analyte concentration in the sample. The apparatus permits remote dosing of the device, which minimizes the likelihood of cross-contamination between the user and the meter. Devices can be mounted on the meter and released from the meter without touching them, to further protect against contamination.

Abstract: A distinctive optical signature permits a fluidic medical diagnostic device to measure an analyte concentration or a property of whole blood, particularly the coagulation time, only after first insuring that a whole blood sample has been introduced into the device. A suitable device has at one end a sample port for introducing a sample and at the other end a bladder for drawing the sample to a measurement area. By requiring a meter, used in conjunction with the device, to first detect the distinctive optical signature, a sample is drawn to the measurement area only if it is whole blood. In that case, a channel carries the sample from the sample port to the measurement area, and a stop junction, between the measurement area and bladder, halts the sample flow. The meter measures a physical property of the blood sample--typically, optical transmittance--after it has interacted with a reagent in the measurement area.

Abstract: A lancing device has a spring-loaded lancet holder slidably mounted within a housing for carrying a disposable lancet and needle. A knob on the back of the device has forward-extending fingers that stop the lancet holder at an adjustable predetermined point after the device has been fired. The fingers not only control the penetration depth of the needle, but also absorb vibrations and reduce noise to cause less pain to the user.

Abstract: A device for use in a medical diagnostic apparatus includes an area for containing a sample of biological fluid as it undergoes a reaction that causes a detectable change in the sample's optical properties. The reaction area is sandwiched between a transparent front layer and a Fresnel reflector layer. The area is illuminated through the front layer, and the light is reflected from the reflector layer to a detector. The detector monitors the light incident on it and calculates, from the change during the course of the reaction, an analyte concentration or property of the fluid sample. The reaction area is optionally heated.

Abstract: A reagent test strip is adapted for use in a blood glucose meter. A sample of whole blood is applied to one surface of a matrix on the strip and the meter measures the reflectance of the opposite surface of the matrix at about 635 nm and 700 nm and calculates from the reflectance the concentration of glucose in the sample. The portion of the applied sample that penetrates the matrix and is visible from the testing surface does not absorb light to any appreciable extent at 700 nm. Nevertheless, the glucose-containing sample interacts with the components of the reagent-containing matrix to cause a change in reflectance at 700 nm that simulates the effect of the blood color. As a result, the strip can be used in meters that measure glucose concentration in whole blood samples in the presence of optically visible hemoglobin.

Abstract: A reagent strip is provided for measuring the concentration of an analyte in a liquid test sample, such as glucose or cholesterol in whole blood. The reagent strip includes a testing pad containing a color-forming reagent system specific to the analyte. The testing pad is disposed so that a side with relatively small pores defines a testing surface and an opposite side with relatively larger pores defines a sample-receiving surface. A porous sample transport medium is attached to the sample-receiving surface. A change in coloration caused by the color-forming reagent system at the testing surface is quantitatively related to the concentration of the analyte in the liquid test sample. The reagent strip may optionally include a rigid support member which facilitates evaluation of the change in coloration by mechanical viewing means. Also provided is a method for determining the concentration of an analyte in a liquid test sample.

Abstract: A method for determining the presence of an analyte in a fluid is described along with various components of an apparatus specifically designed to carry out the method. The method involves taking a reflectance reading from one surface of an inert porous matrix impregnated with a reagent that will interact with the analyte to produce a light-absorbing reaction product when the fluid being analyzed is applied to another surface and migrates through the matrix to the surface being read. Reflectance measurements are made at two separate wavelengths in order to eliminate interferences, and a timing circuit is triggered by an initial decrease in reflectance by the wetting of the surface whose reflectance is being measured by the fluid which passes through the inert matrix. Repeatability in insured by a normalization technique performed on the light source before each reading, and an alignment method operated on the reagent strip prior to emplacement on the apparatus.

Abstract: A needle for endoscopic surgery is curved into an arc of more than 180.degree. and twisted, so that it forms a part of a spiral, with a lateral offset between the needle point and barrel. The needle is sized to fit through a 10 mm trocar and is also blackened, to improve its visibility in a bloody field. The needle curvature is preferably not constant over its entire length, so that different sections have different radii of curvature. The needle is particularly well adapted for performing laporascopically a procedure (Burch Colposuspension) that is used to treat female stress incontinence.

Abstract: A reagent is suitable for measuring the concentration of an analyte in a hemoglobin-containing biological fluid, such as whole blood. The reagent comprises dehydrogenase enzyme that has specificity for the analyte, NAD or an NAD derivative, a tetrazolium dye precursor, a diaphorase enzyme or an analog thereof, and a nitrite salt. The reagent causes dye formation that is a measure of the analyte concentration. The nitrite salt suppresses interfering dye formation caused non-enzymatically by the hemoglobin. Preferably, the reagent is used in a dry strip for measuring ketone bodies, such as beta-hydroxybutyrate.

Abstract: A hollow, frustum-shaped disposable device is used in an apparatus for measuring the concentration of an analyte in a sample of a biological fluid. The smaller end of the frustum has a porous membrane, to which a sample of the fluid may be applied. Preferably, a reagent in the membrane reacts with the analyte to cause a color change. The device is mounted on a meter, which measures the color change and computes from the change the analyte concentration in the sample. The apparatus permits remote dosing of the device, which minimizes the likelihood of cross-contamination between the user and the meter. Devices can be mounted on the meter and released from the meter without touching them, to further protect against contamination.

Abstract: A multilayer reagent test strip measures the concentration of analyte in a liquid sample that is applied to it. The sample is guided to a number of assay areas arrayed along the strip, where the analyte can react with a reagent to cause a color change. Each assay area also includes an inhibitor for the color-change reaction. The inhibitor concentration increases in successive assay areas; thus, the number of areas that change color is a measure of the analyte concentration. The test strip is particularly adapted for measuring glucose in a whole blood sample. In a preferred embodiment, the sample is guided to the assay areas along a path formed by crushing selected areas of a membrane, and the assay areas are uncrushed areas of the membrane.