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 multi-tasking clinical laboratory work-flow system for test sample and reagent transfer to semi-automate various laboratory assays. The system includes a controller having a menu of protocols which provide format instructions to a robotic sample transfer device. The sample transfer device includes a work-flow surface (deck) having defined coordinates for mounting one or more test racks and one or more reaction mediums, and means for interacting a test sample with one or more reagent(s) or gel in a reaction medium.

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.

Abstract: A method for the detection of an analyte in a fluid sample using liposomes encapsulating acridinium esters (lumisomes). Hydrophilic polysubstituted aryl acridinium esters are useful as chemiluminescent markers and can be encapsulated within liposome vesicles without significant leakage of the esters from the vesicles. The lumisomes can be coupled to molecules with biological activity, such as antigens, antibodies, and nucleic acids, and used in luminescent assays.

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 covalently bonded to a suitable carrier molecule, which is also covalently 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: Immunoassays for measuring thyroid hormones such as thyroxine(T.sub.4) and triiodothyronine(T.sub.3) are carried out by incubating a serum sample with either (a) unlabeled thyroglobulin and a labeled antibody to a thyroid hormone or to thyroxine binding globulin(TBG), or (B) labeled thyrogloublin and an unlabeled antibody to a thyroid hormone. The thyroglobulin may be immobilized on an insoluble carrier and the immobilized thyroglobulin is preferably modified by succinylation with succinic anhydride. Whole thyroglobulin can be used or the thyroglobulin can be fragmented into smaller peptides prior to use provided the peptides contain at least one T.sub.3 or T.sub.4 residue per peptide. Preferably, the antibody is a monocional antibody and labeling is with an acridinium ester.

Abstract: An evanescent wave sensor for use in analyzing a medium, the sensor including a shell having a radiation port at a first end and a base at a second end. The base has a dimension greater than that of the radiation port, and inner and outer wall surfaces of the shell extend between the radiation port and the base. The shell is formed of a material having an index of refraction greater than that of the medium. An apparatus and method for analyzing the medium using the sensor may include a receptacle which defines a chamber about a portion of the shell for contacting the medium to the shell for analysis, optical elements for guiding radiation from a radiation source to the radiation port, and optical elements for guiding fluorescent radiation from the shell to a detector of fluorescent radiation.