Abstract: An assay method incorporating at least two different chemiluminescent compounds for detection and/or quantitation of at least two substances in a test sample is described. The synthesis of chemiluminescent reagents or conjugates for use in such methods as well as kits incorporating such reagents are also disclosed. The assays have particular application in the field of clinical diagnostics.

Abstract: A control system for providing a drive signal to an ultrasonic transducer and for controlling the tip motion of the ultrasonic transducer wherein the transducer tip is disposed in a hemolyzing chamber. The control system includes a sensor for sensing the motion of the transducer tip and a feedback circuit coupled between the sensor and the transducer where the feedback circuit provides a feedback signal to control the motion of the transducer tip.

Abstract: A novel fluid sampling device has been developed. This device provides for sample entry to be handled automatically by the instrument, thus allowing the operator to be involved in other activities while the sampling process is underway. It also assures reproduceable sample size, automatically cleans the sampling device between samples, and reduces the risk of user injury. Furthermore, the sampling system allows for the use of any forseeable collection mechanism.

Abstract: The invention pertains to a method for generating the fluorescence of polyanionic fluorophores in low dielectric media with fluorescence activation produced by specific quaternary onium compounds. The method may be used for measuring an analyte and may be useful in sensor devices.

Abstract: A planar, solid-state electrochemical oxygen sensor having a substrate, conductive strips deposited on the substrate, and a dielectric layer insulating portions of the conductive strips except those portions which define a working electrode and at least one second electrode. The working electrode may be defined by an open printed region of the dielectric, or by a needle-punched or laser-burned hole or opening in the dielectric which exposes a small region of one of the conductive strips. A solid electrolyte contacting the electrodes is covered by a semipermeable membrane which may comprise an acrylonitrile butadiene copolymer or an acrylate-based copolymer. A sample chamber is defined by the membrane, a cover member, and a gasket therebetween, and has a volume of from about 1 to about 2 .mu.l. The gasket is formulated from the highly cross-linked polymerization product of epichlorohydrin. All sensor components are selected such that a sensor operable for at least 2 days under normal conditions is produced.

Abstract: A new gene--MN--and proteins/polypeptides encoded therefrom are disclosed. Recombinant nucleic acid molecules for expressing MN proteins/polypeptides and fusion proteins are provided. Expression of the MN gene is disclosed as being associated with tumorigenicity, and the invention concerns methods and compositions for detecting and/or quantitating MN antigen and/or MN-specific antibodies in vertebrate samples that are diagnostic/prognostic for neoplastic and pre-neoplastic disease. Test kits embodying the immunoassays of this invention are provided. MN-specific antibodies are disclosed that can be used diagnostically/prognostically, therapeutically, for imaging, and for affinity purification of MN proteins/polypeptides. Also provided are nucleic acid probes for the MN gene as well as test kits comprising said probes. The invention also concerns vaccines comprising MN proteins/polypeptides which are effective to immunize a vertebrate against neoplastic diseases associated with the expression of MN proteins.

Abstract: A method for measuring hyaluronic acid in a biological sample which comprises (a) coating a solid support with hyaluronic acid; (b) incubating the sample with cartilage proteoglycan; (c) exposing the incubated sample to the coated solid support; (d) then exposing the coated solid support to a keratan sulfate-reactive antibody; (e) determining the amount of antibody linked to keratan sulfate; and (f) correlating the amount of antibody linked to the keratan sulfate to the amount of hyaluronic acid in the sample.

Abstract: A novel fluid sampling device has been developed. This device provides for sample entry to be handled automatically by the instrument, thus allowing the operator to be involved in other activities while the sampling process is underway. It also assures reproduceable sample size, automatically cleans the sampling device between samples, and reduces the risk of user injury. Furthermore, the sampling system allows for the use of any forseeable collection mechanism.

Abstract: A method is described for measuring the amount of analyte present in a sample containing the analyte using a homogeneous amperometric immunoassay. The analyte is chemically bonded to a suitable carrier molecule, which is also chemically bonded to an electroactive molecule. The electroactive molecule, such as ferrocene carboxylic acid, contains a redox center which is capable of transferring a charge to an electrode. A preferred carrier molecule is bovine serum albumin (BSA), while suitable analytes include digoxin, theophylline and HCG. The immunoassay is conveniently performed by applying a voltage to a set of electrodes.

Abstract: Diagnostic/prognostic methods are provided for detecting and/or quantitating in the body fluids, preferably serum, of mammals carrying a malignant tumor burden, elevated levels of a portion of the epidermal growth factor receptor (EGFr) which comprises substantially the EGFr ectodomain having a molecular weight in the range of from about 90 kilodaltons (kd) to about 115 kd, preferably from about 95 kd to about 105 kd, and more preferably about 100 kd. Substantially pure compositions comprising said EGFr ectodoman protein and/or fragments thereof are disclosed as well as test kits for performing the disclosed assays.

Abstract: An evanescent wave sensor and method for use in analyzing one or more media, the sensor including a waveguide having first and second wave propagating surfaces. The waveguide propagates an input signal along the waveguide between the first and second surfaces. The first surface receives a first radiation signal which indicates the presence of a first analyte, and the second surface receives a second radiation signal representing one or both of a second analyte and a reference. The first and second surfaces can both be contacted with a single medium, or with two separate media, and one or more output signals can be detected.

Abstract: A method of isolation of a material with similar immunological properties to CA-195 from human amniotic fluid has been disclosed. This material can be substituted for CA-195 in many processes, for example in the preparation of analytical control materials.

Abstract: This invention relates to methods that have been found useful in reducing non-specific binding in immunochemical assays, via methods that can be implemented much faster than those used by Ishikawa. The techniques include the use of a lipophilic bridge, such as a liposome, or the elution of the antigen-antibody complex from the solid phase by the use of an anti-idiotypic antibody or an antibody, or the use of a heterologous reversible bridge.

Abstract: A squamous cell carcinoma-like (SCC-like) immunoreactive antigen has been identified in human female urine. This material appears to perform the same as and quite likely have the same composition as squamous cell carcinoma associated antigen (SCC) which is a subfraction of tumor antigen 4 (TA-4). This patent also relates to the isolation, and use, of the SCC-like material.

Abstract: Disclosed is a novel immunoassay methodology, bridge immunoassay, which employs a primary free solution analyte/receptor binding reaction, for example, in a sandwich-type format (two or more analyte receptors), in a competitive format (single analyte receptor) or in a related immunoassay format, and a universal solid phase and capture system. The universal capture system comprises a first receptor bound to a solid phase and a bridge receptor (a second receptor) which functions both as a ligand for said bound first receptor and as a receptor for a ligand conjugated to a sample analyte receptor (a third receptor). The bridge receptor is used to immobilize the immunocomplexes formed free in solution by linking them to the bound first receptor. The universal capture system can be used for assays for any analyte as the bridge receptor binds to a ligand, for example, a hapten or binding protein, conjugated to the sample analyte receptor. Methods, compositions and test kits for such bridge immunoassays are provided.

Abstract: This invention involved the discovery of novel polymers and a process for their preparation. The polymers were prepared by the nucleophilic substitution, at room temperature, of PVC with substituted alkyltrialkoxysilanes, which can be cured at room temperature to give adhesion of PVC to hydrophilic substrates. These polymers are particularly useful as adhesion promoters in ion-selective electrodes. The invention also involved the application of these adhesive primers to planar electrode substrates to give greatly improved performance in the response of ion-selective electrodes.

Abstract: A capnography system has a 4.2 micron LED emitter of narrow-band radiation having a center wavelength very close to the 4.26 micron absorption band of CO.sub.2 breathing gas in a breathing tube. The radiation passes through windows in an insert in the breathing passage between the LED source and an infrared detector in an opposite side of the insert. A mirror is optionally placed in the opposite wall to reflect the radiation back to the detector which is then placed on the same side as the emitter. The LED emitter is pulsed at a low frequency repetition rate with a regulated voltage from a power supply. The detector output is applied to processing electronics which includes amplification and dual integrators that integrate the detector output on two signal paths, one the integration of each pulse and the other the integration of detector background with the two differences to provide self calibration against drift and noise.

Abstract: This invention is directed to novel nucleophilic polysubstituted aryl acridinium esters and to novel conjugates thereof. The novel nucleophilic polysubstituted aryl acridinium esters and novel conjugates thereof are useful in biological assays, including novel assays for the determination of Vitamin B.sub.12, folate, cortisol, estradiol, and thromboxane B.sub.2.