Abstract: A method for aiding in the diagnosis of, and monitoring the progression of, breast cancer in a patient by measuring the amount of NCA 50/90 in a blood sample, e.g. serum sample, obtained from the patient. Measurement in a single sample of an amount of NCA 50/90 significantly higher than the mean amount of NCA 50/90 in the normal population is an indication of breast cancer in the patient. The progression of breast cancer can also be monitored by performing a series of specific immunoassays over time to determine changes in the level of NCA 50/90 in blood samples. Increases in blood NCA 50/90 levels over time are indicative of a deteriorating condition whereas decreasing levels of blood NCA 50/90 over time indicate an improving condition.

Abstract: A method is disclosed for differentiating white blood cells. The method uses at least one surfactant and at least one dilute acid which together selectively strip the cytoplasm from certain classes of white blood cells and not others. More particularly, the method causes lysis of lymphocytes, monocytes, eosinophils and neutrophils, but not basophils. Thus, basophils are differentiated from other PMN sub-classes by their appearance as intact cells. The method totally avoids the need for dye preparation and the vagaries of staining techniques and can be used either manually or with instrumentation.

Abstract: 2-Thiazolyl tetrazolium salt compounds characterized by a reflectance spectrum exhibiting an extended plateau above about 600-650 nm. Such compounds are useful as chromogenic indicators for reducing substances such as NADH. The reflectance plateau confers improved accuracy to analytical assays, particularly for the determination of analytes of medical diagnostic significance, in which a colorimetric response on a reagent carrier matrix is measured by reflectance.

Abstract: 2-Benzothiazolyl tetrazolium salt compounds have been found to be characterized by a reflectance spectrum exhibiting an extended plateau above about 600-650 nm. Such compounds are useful as chromogenic indicators for reducing substances such as NADH. The reflectance plateau confers improved accuracy to analytical assays, particularly for the determination of analytes of medical diagnostic significance, in which a colorimetric response on a reagent carrier matrix is measured by reflectance.

Abstract: Phenyl substituted 2-thiazolyl tetrazolium salt compounds characterized by a reflectance spectrum exhibiting an extended plateau above about 600-650 nm. Such compounds are useful as chromogenic indicators for reducing substances such as NADH. The reflectance plateau confers improved accuracy to analytical assays, particularly for the determination of analytes of medical diagnostic significance, in which a colorimetric response on a reagent carrier matrix is measured by reflectance.

Abstract: Methods for blood sample preparation using reagent compositions which include a zwitterionic surfactant for sphering of cells to eliminate orientational noise. When the reagent composition including a for staining a subset of cells is reacted with an anticoagulated blood sample, and the reaction mixture is passed through the sensing region of a flow cytometer, the light scattered and absorbed by each cell is measured, the stained cells can be distinguished from the unstained cells, and when the cells are reticulocytes and mature erythrocytes, respectively, the volume and hemoglobin concentration of each reticulocyte or erythrocyte, and the hemoglobin content, mean cell volume, mean corpuscular hemoglobin concentration, and mean cell hemoglobin of the reticulocytes or erythrocytes are calculated from the measured cell-by-cell volume and hemoglobin concentration.

Abstract: A high-precision liquid reagent delivery system is provided for convenient and efficient gravity flow delivery of substantially the entire volume of reagent contained within a sealed formed tray. The delivery system comprises a formed tray defining a curved cavity for holding a predetermined amount of liquid, and a substantially planar ledge surface defined around the cavity opening. The surfaces of the cavity are non-porous, uniform and smoothly converging to a point of liquid discharge at an intersection of the cavity and the ledge surface. The ledge surface further defines an apex extending longitudinally from the point of liquid discharge and defines a guide path for the delivery of liquid contained within the tray. The system also includes a flexible cover removably affixed to the ledge surface of the tray for forming a sealed chamber between the cavity and the affixed cover for containment of liquid.

Abstract: Sample liquid analysis apparatus and method for the formation and supply to a conduit of a stream of successive sample liquid test packages, and the repeated bi-directional displacement of the sample liquids test package stream in the conduit, sample liquid analysis apparatus operatively associated with the conduit for repeated, time-spaced analyses in turn of the sample liquids in each of the sample liquid test packages. Each of the test packages comprises a first segment of a sample liquid and a first reagent liquid, and a second segment of a second reagent liquid spaced from the first segment by a different fluid in the test package.

Abstract: A chromogenic compound found to be especially selective in the determination of calcium in blood of the general formula (I): ##STR1## where: R is hydrogen or lower alkyl;X is CH.sub.2, CH.sub.2 CH.sub.2, CH.dbd.CH, O, S, SO.sub.2, S--S, or NR;X is CH, C--OH or N;M is p-nitrophenylazo, 2,4-dinitrophenylazo, 2,4,6-trinitrophenylazo, p-nitrostyryl, p-benzoquinoneimino, bis-(4-dimethylaminophenyl) hydroxymethyl, 3-phenylisothiazolyl-5-azo, thiazolyl-5-azo, or isothiazolyl-5-azo;k is 1;l is 0 or 1; andn is 0 or 1.

Abstract: Use of a lithium salt, particularly lithium thiocyanate, as an agent for lysing red blood cells and denaturing hemoglobin in the performance of an immunoassay to detect the relative amount of a hemoglobin derivative in a blood sample. The method is particularly useful in the determination of hemoglobin Alc. The method provides a rapid means for releasing hemoglobin from red blood cells by lysis and for exposing the epitope that is characteristic of the Alc form. Low concentrations of the lithium salt provide rapid release and denaturation of hemoglobin without the need for dilution prior to the performance of the immunoassay.

Abstract: Specific nucleic acid sequences are amplified through the use of a hairpin probe which, upon hybridization with and ligation to, a target sequence is capable of being transcribed. The probe comprises a single stranded self-complementary sequence which, under hybridizing conditions, forms a hairpin structure having a functional promoter region, and further comprises a single stranded probe sequence extending from the 3' end of the hairpin sequence. Upon hybridization with a target sequence complementary to the probe sequence and ligation of the 3' end of the hybridized target sequence to the 5' end of the hairpin probe, the target sequence is rendered transcribable in the presence of a suitable RNA polymerase and appropriate ribonucleoside triphosphate (rNTPs).

Abstract: A nucleic acid hybridization assay employing an immobilized or immobilizable polynucleotide probe selected to form DNA.RNA or RNA.RNA hybrids with the particular polynucleotide sequence to be determined. Resulting hybrids are detected by binding of an antibody reagent, preferably labeled with a detectable chemical group, selective for binding the hybrids in the presence of the single stranded sample and probe nucleic acids. No immobilization or labeling of sample nucleic acids is necessary and hybridization can be performed entirely in solution.

Abstract: Immunoassay methods useful for the determination of the presence or absence of CEA gene family members are provided. Methods are provided that differentiate between members of the CEA gene family. In addition, monoclonal antibodies against CEA-family members, said antibodies specific to TM-CEA, CEA, or NCA, and not cross-reactive with other CEA family members are provided. Further, antibodies specific to two of three CEA gene family member, TM-CEA and NCA but not CEA and CEA and NCA but not TM-CEA, TM-CEA and CEA but not NCA, are provided. Said monoclonal antibodies include antibodies against native protein and antibodies against denatured protein. Also provided are hybridoma cell lines secreting said antibodies, and pharmaceutical compositions containing said antibodies or fragments thereof.

Abstract: Diagnosis of insulin-dependent (Type I) diabetes mellitus (IDDM) by contacting a blood sample from a patient with an immunoreagent comprising epitopes of two or more of glutamic acid decarboxylase (GAD) and the pancreatic islet cell antigens referred to as ICA512 and ICA12. Binding of antibodies present in the blood sample with one or more of such epitopes correlates with IDDM or a potential for developing IDDM. In clinical testing, about 80 percent of sera from newly diagnosed IDDM patients react positively with at least one epitope in a GAD/ICA512 panel. Reactivity with the GAD/ICA512/ICA12 panel is between about 80 and 90 percent. The method is useful in screening patients for pre-IDDM, for distinguishing IDDM from Type II diabetes, and for monitoring therapy.

Abstract: Chromogenic enzyme substrate compounds comprising a dibenz[b,e] [1,4]oxazepinone or dibenzo[b,e] [1,4]thiazepinone nucleus having an enzyme-cleavable group such as a radical of a sugar, carboxylic acid, amino acid, peptide, phosphoric acid, or sulfuric acid. The substrate compounds are, in general, highly soluble in aqueous media and only slightly colored, and produce, upon enzyme cleavage, a chromogen exhibiting a large change in absorbance and a pKa below 7. Such substrates find use as indicators for the determination of enzyme analytes and enzymes used as markers in a variety of assays, including immunoassays.

Abstract: A method for determining the adequacy of a cervical or urethral test specimen collected for an immunological assay to detect the presence of Chlamydia trachomatis. Cells present in the specimen are disrupted to expose a substance present in or on C. triachomatis that is detectable by immunological reaction. In order to determine if the test specimen contains an adequate amount of the cervical or urethral cell type that serves as a host cell for C. trachomatis, the disrupted specimen is also reacted with an immunological reagent that produces a detectable complex upon specific binding with a substance present in or on columnar epithelial cells. The present invention therefore provides a control reaction that verifies the adequacy of the collected test specimen and thereby increases the confidence that a negative test result for the presence of Chlamydia indicates the absence of a C. trachomatis infection in the patient.

Abstract: Analytical reaction cassette and method for performing sequential analytical assay procedures to determine the amount of an analyte in a liquid test mixture. The reaction cassette can be in the form of a substantially square container having a substantially horizontal axis of rotation and incorporated with one or more analytical reagents such that they are contacted with a liquid test mixture in a desired ordered sequence to perform a particular assay procedure. Corners provided by the substantially square configuration of the reaction cassette disrupt the flow of liquids disposed in the reaction cassette upon contact therewith to thereby agitate and mix such liquids. A liquid disposed in the reaction cassette is capable of being manipulated and mixed therein by rotating the reaction cassette about the horizontal axis at sufficiently low velocities wherein the transport of such liquid is noncentrifugal and due substantially only to gravitational force.

Abstract: Naphthotriazolium salts which are chromogenic indicators for reducing substrate, such as NADH or NADPH.

Abstract: General classes of 2-thiazolyl tetrazolium salt compounds have been found to be characterized by a reflectance spectrum exhibiting an extended plateau above about 600-650 nm. Such compounds are useful as chromogenic indicators for reducing substances such as NADH. The reflectance plateau confers improved accuracy to analytical assays, particularly for the determination of analytes of medical diagnostic significance, in which a colorimetric response on a reagent carrier matrix is measured by reflectance.

Abstract: Chromogenic merocyanine enzyme substrate compounds of the general formula: ##STR1## where Y is an enzymatically-cleavable group such as a radical of a sugar, carboxylic acid, amino acid, peptide, phosphoric acid, or sulfuric acid; A and B represent residues that complete 5- or 6-membered ring systems; R.sup.1 is substituted or unsubstituted alkyl; R.sup.2 and R.sup.3, independently, are hydrogen or lower alkyl; m, n, and p, which can be different, are integers from 0 through 3 provided that m+n+p must be at least 2; and X is an appropriate counterion (anion).