Abstract: Medical devices and methods for diagnostic data collection and transmission are described.

Abstract: A laminated capillary array assembly having a plurality of capillaries substantially entirely enclosed by a first and a second substrate laminated together. Also disclosed is a capillary array electrophoresis system including the above capillary assembly attached to a sample intake block and an array fitting. Also described is a method for making a laminated capillary array assembly by placing a first substrate on a template having a desired shape, arranging capillaries on the first substrate, and laminating a second substrate on the first substrate to enclose the capillaries between the substrates.

Abstract: This invention relates to methods of assaying one or more analytes simultaneously. The assays of this invention are capable of providing wide dynamic range and rapid processing times. A wide dynamic working range is achieved by simultaneously incubating a sample which may contain the analyte(s) of interest with two or more independently determinable classes of particles coated with an analyte-specific binding partner. The two or more particle classes differ from each other at least in size. The analyte concentration is obtained from readings derived from these two classes by means of a combined standard curve.

Abstract: This invention provides &bgr;-D-Glucuronidase substrates of the formula: wherein R1, R2, and R7-R12 are independently selected from the group consisting of: hydrogen, fluorine, chlorine, bromine, iodine, alkyl, hydroxyl, alkoxy, carboxyl and nitro groups; R3-R6 are independently selected from the group consisting of hydrogen, fluorine, chlorine, bromine, iodine, nitro and amino; and M+ is selected from the group consisting of: proton, lithium, sodium, potassium, magnesium, calcium, barium, and ammonium ion.

Abstract: A chromatographic assay device according to the present invention provides a unidirectional immunoassay for an analyte in a whole blood sample with improved sensitivity and freedom from interference.

Abstract: A fluid-moving device with an integrated valve is disclosed. The device includes a housing defining a suction chamber and at least one internal passageway formed inside the housing. A first end of the internal passageway opens to the suction chamber and a second end of the internal passageway connects to an outside surface of the housing. The fluid-moving device of the present invention also includes a pumping structure disposed inside the suction chamber for generating a pressure inside the suction chamber. The device may also include valve passageways formed inside the housing. In one embodiment, a manifold is utilized for connecting the valve passageways to fluid supplies and fluid sinks. The manifold has a casing, at least one input port, at least one output port, and a plurality of internal manifold passageways formed in the manifold casing. A method of making a fluid-moving device with an integrated valve of the present invention is also disclosed.

Abstract: Methods for detecting BRCA1 mutations are provided. The methods include the steps of determining the amount of the BRCA1 polypeptide contained in a sample of the subject, and correlating the amount of BRCA1 to the presence of the BRCA1 gene mutation in the subject, wherein the amount below a predetermined cutoff value is an indication of the presence of the mutation in the BRCA1 gene of the subject. The methods of the present invention are well suited for use to determine a condition associated with BRCA1 mutation, such as a predisposition to breast cancer, ovarian cancer, colorectal, and prostate cancers, and the presence or prognosis of breast cancer, ovarian cancer, colorectal, and prostate cancers.

Abstract: A lithium ion-selective membrane that favors the bonding of lithium and depresses sodium interference is invented by a charge balance approach. A lithium ion-selective electrode (Li-ISE) having the membrane of this invention demonstrates a fast kinetic response, good precision and reproducibility, high sensitivity and the ability to retain the sensitivity after a long-term contact with biological samples. The sensor shows Nernst linearity with a slope of 55.4 mV for lithium ion concentrations between 0.5 &mgr;mol/L and 10 mmol/L. The membrane includes at least about 2% by weight of 6,6-dibenzyl-1,4,8,11 tetraoxacyclotetradecane ionophore; from about 0.025% to about 1% by weight of potassium tetrakis(4-chlorophenyl)borate additive; a plasticizer; and a polymeric material.

Abstract: A substantially pure and isolated novel form of prostate specific antigen (PSA) is provided. The novel form of PSA of the present invention comprises at least one clip at Lys 182 of the amino acid sequence of a mature form of PSA. Preferably, the novel form of PSA additionally comprises one or more clips at a location selected from a group consisting of Ile 1, Lys 145, and Lys 146. More preferably, the form of PSA contains at least two clips at Lys 145 and Lys 182 of the amino acid sequence of a mature form of PSA. The novel forms of PSA exist at an elevated level in patients suspected of having benign prostatic hyperplasia (BPH) and therefore may be used as a serum mark or an immunohistological marker to help distinguish BPH from prostate cancer. Antibodies recognizing the novel forms of PSA and immunoassays that detect and determine the novel forms of PSA of the present invention in a sample are also provided.

Abstract: The present invention provides a novel complex of hK2 and PI-6 and methods of using the novel complex and its constituents. The novel complexes of hK2 and PI-6 of the present invention and the PI-6 exist at an elevated level in prostate cancer tissues. PI-6 also exists at an elevated level in other types of cancer cells. Therefore, the hK2-PI6 complexes and PI-6 of the present invention may be used as a serum marker for detecting cancers, particularly prostate cancer. They may also be used as an immunohistological marker to detect prostate cancer tissues. In accordance with the present invention, the hK2-PI6 complexes of the present invention may be detected in patient tissue samples by immunohistochemical and/or in patient fluid samples by in vitro immunoassay procedures. Diagnostic methods for detecting the existence of prostate cancer is also provided.

Abstract: Formamide with low conductivity and a neutral or slightly basic pH is provided. Such formamide may be used in a sample loading solution for capillary electrophoretic separation of biomolecular analytes to enhance the efficiency of sample injection into the capillary and the intensity of the signal. Formamide of the present invention may be obtained by first purifying the formamide to a conductivity of below 7 micro mho, and then adjusting the pH of the purified formamide with a base to a range of about pH 6.5 to 7.5. The purification may be carried out by first removing the water from the formamide, and then distilling the dried formamide until the conductivity of formamide is below about 7 micro mho.

Abstract: A removable conformal liner for a centrifuge container is described. The liner has a flexible or semi-rigid body with an opening for introducing a sample. When the liner is inserted into an internal cavity of a centrifuge container, the body of the liner conforms to the interior cavity. The liner body may be made of a material that is sufficiently resilient to allow a reversible deformation of the body by folding, twisting, collapsing, rolling, or pleating. Also disclosed is a centrifuge container assembly, including a container suitable for centrifuging and a removable liner with a flexible or semi-rigid body placed into the container. The centrifuge container assembly of this invention may also have retaining-means for retaining the liner in a fixed position within the container. Also provided by the present invention is a method for separating solids from suspensions by centrifugation.

Abstract: A method of distinguishing prostate cancer from benign prostatic hyperplasia (BPH) is provided. The mathematical combination or ratio of proPSA and BPSA serum or tissue markers may be used for distinguishing benign prostatic hyperplasia (BPH) from prostate cancer. It is the discovery of the present invention that BPSA is preferentially elevated in transition zone prostate tissue whereas pPSA is elevated in the peripheral zone of prostate tissue. A kit for aiding in distinguishing BPH from prostate cancer is also provided.