Abstract: A mixture of recombinant mono- and poly-epitope proteic materials able to fully replace the viral antigens when used in an enzyme immunoassay (EIA) is disclosed; the mixture includes a poly-epitope fusion protein having a first region formed by an amino acid sequence (H10) corresponding to that of the last 233 amino acids of the COOH terminus of the viral protein p52 or to a part thereof, a second region formed by an amino acid sequence (F3) corresponding to that of the last 43 amino acids of the COOH terminus of viral protein pp150 or to a part thereof, and a third region formed by an amino acid sequence (A1C2) corresponding to that taken from aa 595 to aa 614, proceeding in direction 5'.fwdarw.3', of the same viral protein pp150; and, in combination, a second fusion protein including a sequence of amino acids corresponding to that taken, proceeding in direction 5'.fwdarw.

Abstract: Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of:(a) forming an unobstructed opening in the area of the skin from which the sample of blood is to be extracted; and(b) extracting the sample of blood from the unobstructed opening in the skin, with the aid of a vacuum and a stretching of the skin.In another aspect of the invention, an apparatus for carrying out the method described previously is provided. The apparatus comprises:(a) a device for forming an unobstructed opening in an area of skin from which said sample is to be extracted, preferably a lancing assembly; and(b) a vacuum pump.Preferably, the apparatus also includes a housing.In another aspect of this invention, an article is provided for an article capable of both collecting blood and detecting an analyte in that blood is provided.

Abstract: Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of:(a) forming an unobstructed opening in the area of the skin from which the sample of blood is to be extracted; and(b) extracting the sample of blood from the unobstructed opening in the skin, with the aid of a vacuum and a stretching of the skin.In another aspect of the invention, an apparatus for carrying out the method described previously is provided. The apparatus comprises:(a) a device for forming an unobstructed opening in an area of skin from which said sample is to be extracted, preferably a lancing assembly; and(b) a vacuum pump.Preferably, the apparatus also includes a housing.It has also been discovered that an improved design and construction of the nosepiece can provide enhanced collection of blood from the unobstructed opening in the skin.

Abstract: A multiplex sensor and a method of use that provides enhanced selectivity and sensitivity. In this method, one or more parameters of the sample are measured by means of multiple spectroscopic techniques, and the interferences from physiological and spectral variables are reduced or eliminated. In one embodiment of the present invention comprises a multiplex sensor and a method of use that provides enhanced selectivity and sensitivity. One or more parameters of the sample are measured by means of at least two different spectroscopic techniques, wherein the at least two different spectroscopic techniques are selected from the group consisting of:(a) infrared absorbance(b) scattering(c) emission(d) polarization, and(e) photoacoustics.

Abstract: A method and apparatus for measuring the concentration of an analyte of interest, e.g. glucose, in blood non-invasively, i.e., without penetrating the skin or obtaining a biological sample from the body of a patient. The method and apparatus uses a plurality of measurement channels with appropriate wavelengths of interest to control variations of signal and to separate the contribution of the analyte of interest from those of interfering compounds. The method and apparatus of this invention can also be adapted to allow a portion of a body part to be engorged with blood to bring about greater accuracy in optical measurements. In the method of this invention, at least two similar, but not identical, measurements are made concurrently. For example, at least two measurements can be made with similar, but not identical, wavelengths of electromagnetic radiation. The two wavelengths should not be overlapping to allow maximum non-identity.

Abstract: A noninvasive Raman sensor and an associated method of measuring at least one parameter of a sample, such as the presence or concentration of an analyte. The sensor includes(a) at least one source of light capable of irradiating the sample with substantially monochromatic light;(b) a filtering module for filtering light scattered by the sample, that includes at least one bandpass filter capable of transmitting two different spectral windows; and(c) at least one detector.The method includes(a) irradiating a sample with light from a source of substantially monochromatic light,(b) collecting light that is scattered by the sample,(c) analyzing the scattered light by passing the light through a filtering module that includes at least one bandpass filter that is transmissive for at least two spectral windows, and(d) detecting light that has been filtered by said filtering module.

Abstract: Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of:(a) forming an unobstructed opening in the area of the skin from which the sample of blood is to be extracted; and(b) extracting the sample of blood from the unobstructed opening in the skin, with the aid of a vacuum and a stretching of the skin.In another aspect of the invention, an apparatus for carrying out the method described previously is provided. The apparatus comprises:(a) a device for forming an unobstructed opening in an area of skin from which said sample is to be extracted, preferably a lancing assembly; and(b) a vacuum pump.Preferably, the apparatus also includes a housing.

Abstract: The present invention relates to a device for the sampling of blood or other body fluids which includes means for the direct measurement of the analyte of interest within the fluid. Also disclosed is a `closed-loop` device and method wherein the analyte is measured and the required amount of drug is determined and injected, without removal of the device from the patient's body.

Abstract: A method for increasing the permeability of the stratum corneum by means of a source of light, preferably a laser, more preferably a pulsed laser. By increasing the permeability of the stratum corneum, access to the interstitial fluid is achieved, thereby enabling measurement of analytes in the interstitial fluid. In one aspect, the method comprises the steps of:(a) providing a source of light having a wavelength of from about 930 nm to about 1040 nm; and(b) exposing a region of the stratum corneum of the patient to said source of light for a period of time sufficient to form an opening in the stratum corneum.

Abstract: Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of:(a) forming an unobstructed opening in the area of the skin from which the sample of blood is to be extracted; and(b) extracting the sample of blood from the unobstructed opening in the skin, with the aid of a vacuum and a stretching of the skin.In another aspect of the invention, an apparatus for carrying out the method described previously is provided. The apparatus comprises:(a) a device for forming an unobstructed opening in an area of skin from which said sample is to be extracted, preferably a lancing assembly; and(b) a vacuum pump.Preferably, the apparatus also includes a housing.In a further aspect of the invention, a pneumatic lancing assembly is provided. The pneumatic lancing assembly uses differential gas pressure to thrust a lancet into skin tissue.

Abstract: Intercalator compounds of formula I-T.sub.m as defined herein are provided which are comprised of intercalator moieties, or substituted intercalator moieties, having one or more functionalized chains, or moieties, and which compounds provide a high affinity for binding to the DNA molecule and show reduced self-quenching, while providing superior transport kinetics. The compounds have been found to provide enhanced fluorescence when bound to a DNA molecule within a fluorescent flow cytometry environment which is about eight to ten times brighter in fluorescence than "bis" structure conventional intercalating agents and other known intercalating agents utilized in flow cytometry environment.

Abstract: The present invention relates to a device for the sampling of blood or other body fluids which includes means for the direct measurement of the analyte of interest within the fluid. Also disclosed is a `closed-loop` device and method wherein the analyte is measured and the required amount of drug is determined and injected, without removal of the device from the patient's body.

Abstract: The present disclosure provides the use of vacuum to enhance the transdermal transport of fluids in sampling methods for the detection of analytes in a patient's blood.

Abstract: Assay methods utilizing the response of a magnetically responsive reagent to the influence of a magnetic field to qualitatively or quantitatively measure binding between specific binding pair members. According to the invention, the presence of an analyte mediates whether or not the magnetically responsive reagent binds to a mobile solid phase reagent. The extent of binding will modulate the response of the magnetically responsive reagent or that of the mobile solid phase reagent, or both, to the influence of a magnetic field. Hence, by measuring the response to the magnetic field of the magnetically responsive reagent, or that of the mobile solid phase reagent, the presence or amount of analyte contained in a test sample can accurately be determined. The invention utilizes various devices to carry out the assay methods described.

Abstract: Fluorescent conjugates suitable for use in flow cytometry and other biological applications. The fluorescent conjugates comprise an antibody having a polymeric dye bound thereto. The polymeric dye is preferably enhanced by a hydrophobic and conformationally restrictive moiety either bound thereto or in close association therewith. The hydrophobic and conformationally restrictive moiety is preferably derived from a cyclodextrin. The polymeric dye comprises a polymeric entity having signal-generating groups, such as aminostyryl pyridinium dye residues attached thereto. The fluorescent conjugates exhibit exceptional stability characteristics and avoid many of the problems of energy transfer, bio-conjugability, and solubility.

Abstract: Cyanide-free reagents for the determination of hemoglobin and leukocytes present in a blood sample contain an aqueous solution of at least one quaternary ammonium salt, preferably selected from the group of alkyltrimethylammonium salts, alkyldimethylbenzylammonium salts or alkylpyridium salts consisting of tetradecyltrimethyl ammonium bromide (TTAB), dodecyltrimethyl ammonium chloride, cetyltrimethyl ammonium bromide, hexadecyltrimethyl ammonium bromide and benzalkonium chlorides, and hydroxylamine salts, especially hydrochloride, sulfate and phosphates and other acid salts. The method involves mixing the reagent with a diluent- diluted blood sample, presenting it to an absorbance spectrophotometer and measuring the resulting optical density as an indicator of hemoglobin concentration. This cyanide-free reagent could be used solely for hemoglobin determinations, or , it can also be used in leukocyte counting and sizing using hematology instrumentation.

Abstract: A liquid heater assembly including a heater body having therein a coiled tube for passing liquids, a pair of heating elements, a thermistor, a thermostat, and a backup thermostat. Liquid enters the coiled liquid tube at an inlet end and exits the coiled liquid tube at an outlet end. The coiled liquid tube is positioned within the heater body between the pair of heating elements. The outlet end extends below a planar surface of the heater body. The thermistor detects the temperature changes of the heater body. The resistance of the thermistor is used to regulate the supply of power to the heating elements. The thermostat and the backup thermostat are connected in series between the power source and the heating elements to provide a safety shutoff when the heater body reaches a predetermined overheat temperature. The heater body is maintained at a predetermined temperature by regulating the electrical current to the heating elements.

Abstract: The present invention relates to analytical devices for determining the presence or amount of an analyte in a test sample. The analytical devices comprise an inlet port, a vent, a channel, and an array of structures. The structures have immobilized reagent covalently or non-covalently attached to the surface of the structures. The immobilized reagent captures analyte in the test sample where it is detected by a detection system. The present invention also provides methods and reagents for performing assays utilizing the analytical devices of the present invention. The present invention also provides methods of manufacturing the analytical devices of the present invention.

Abstract: A method and kit for measurement of a steroid by means of a competitive immunoassay, preferably a competitive enzyme immunoassay. The method and kit involve the use of a steroid analogue conjugated to a label. The steroids that are amenable to detection by the method and kit of the present invention include estradiol and progesterone. The method comprises the steps of:a. incubating a mixture of a test sample suspected of containing a given steroid, a solid phase coupled to an antibody specific for that steroid, and a conjugate of an analogue of that steroid to form steroid/antibody complexes and conjugate/antibody complexes on said solid phase;b. separating said solid phase from said mixture;c. measuring the amount of label present in said mixture or in said solid phase; andd. determining the amount of steroid in said sample from the amount of label. The kit comprises a solid phase coupled to an antibody specific for a steroid and a conjugate of an analogue of that steroid.