Abstract: The invention describes quality control devices for assays that measure analytes in cells and tissue samples, and methods of use thereof. In particular, the quality control device comprises a matrix affixed with synthetic controls in different concentrations, or different synthetic controls. The quality control device can be adhered to a microscope slide and processed simultaneously with a tissue sample.

Abstract: A method of attaching unmodified biopolymers, particularly, unmodified polynucleotides, directly to a solid support is provided. The method includes the steps of (a) providing unmodified biopolymers; (b) providing a solid support having at least one surface comprising pendant acyl fluoride functionalities, and (c) contacting the unmodified biopolymers with the solid support under a condition sufficient for allowing the attachment of the biopolymers to the solid support. The unmodified biopolymers may be nucleic acids, polypeptides, proteins, carbohydrates, lipids and analogues thereof. The unmodified polynucleotides may be DNA, RNA or synthesized oligonucleotides. The DNA may be single or double stranded. A device including a solid support and unmodified biopolymers attached to the solid support by reaction with the pendant acyl fluoride functionalities of the solid support is also provided. The methods and devices of the present invention may be used in performing hybridization assays and immunoassays.

Abstract: The invention relates to a method and apparatus for detecting specific target cells in a simple and time-saving way, using paramagnetic particles, antibodies recognizing the Fc portions of target-cell associating antibodies and target-cell associating antibodies directed to specific antigen determinants in the target-cell membranes. Incubation of the cell suspension with detergent and/or second antibodies or antibody fragments, prelabeled or not with fluorescent agents, metallocolloids, radioisotopes, biotin complexes or certain enzymes allowing visualization, dramatically increase the specificity of the method. The method and apparatus described provides a solid support and permanent record which is easily viewed by microscopy, permits viewing and quantification of the whole specimen rather than small fractions thereof and allows the use of large specimen volumes to be analysed, the device may also be scanned automatically by conventional densitometric technology.

Abstract: A method of analyzing cells in a carrier solution comprises the following steps: (a) Introducing the carrier solution into a conduit having a surface portion (preferably a substantially flat surface portion). The carrier solution has the cells suspended therein. (b) Allowing the cells to settle on the surface portion, the surface portion including at least one imaging field. In an alternate embodiment, one or more discreet capture zones (e.g., formed from an affinity species immobilized on the substrate or a textured region on the substrate) are formed on the surface portion, and this step (b) comprises capturing the cells in the capture zone. (c) Sequentially interrogating a plurality of the cells in the imaging field with emitted light. (d) Processing resultant light from the imaging field. (e) Generating digital information for each of the plurality of cells from the resultant light. (f) Generating a response file for each of the plurality of cells from the digital information.

Abstract: A method of determining the presence of chronic volume dependent hypertension is provided wherein a determination is made as to whether there has been a substantial reduction in phosphorylation of the blood-derived protein or renal proximal brush border membrane protein and if such reduction exists concluding that chronic volume dependent hypertension exists in a patient. The method may advantageously be practiced by employing blood serum or blood plasma as the body specimen containing the protein in determining whether a patient has chronic volume dependent hypertension, a cellular component of the blood, such as a blood-derived protein coming from the plasma membrane of lymphocytes. The method may include subsequent therapeutic patient treatment. Related diagnostic apparatus is also provided.

Abstract: A microparticle light scattering agglutination assay is disclosed. The assay comprises a mixture of particles having strong light scattering properties with particles having weak light scattering properties. The particles having strong light scattering properties carry a binding partner of high reactivity with the analyte. The particles having weak light scattering properties carry a binding partner of low reactivity with the analyte. Reagents useful in the assay are also disclosed.

Abstract: Tartrate-resistant acid phosphatase (TRAP) has been used as a marker for bone resorption. However, there are two forms of said enzyme in the body: TRAP 5a and TRAP 5b, of which TRAP 5b is a much more specific marker. The present invention is directed to an immunoassay for measuring the bone resorption rate, which methods enables the specific determination of TRAP 5b, whereby the amount of TRAP 5b reflects the bone resorption rate. The method is useful in diagnosing disorders associated with a change in the bone resorption rate, such as osteoporosis. Methods of screening for susceptibility to such disorders, and method of monitoring the effect of treatment are also provided. Further a test-kit useful in said methods is provided.

Abstract: Heterogenous and homogenous assays are provided for the detection of protease inhibitory activity in a sample or target compound, taking advantage of the chemiluminescent characteristics of 1,2-dioxetanes. In the heterogenous assay, a peptide bearing a cleavage site for the protease of interest is provided with a first member of a first ligand binding pair at one end, and a first member of a second ligand binding pair at the other end. The other member of the first ligand binding pair is attached to a surface, which binds the peptide, or protease substrate, to the surface. The peptide substrate is combined with the protease and target compound or sample. Substrate cleavage, if not inhibited, is allowed to occur, and any unbound cleaved fragments are removed. An enzyme complexed with the second member of the second ligand binding pair is added, and allowed to bind to any of the (uncleaved) first member of the second ligand binding pair remaining.

Abstract: Formed constituents of a quiescent anticoagulated whole blood sample are optically or visually analyzed in a sample chamber which has a varying through plane thickness due to convergent opposing sample chamber walls. At least one of the convergent walls of the chamber is transparent so that the blood sample constituents can be observed. The chamber's varying thickness produces a first lesser thickness region in the chamber wherein a quiescent monolayer of red blood cells in the sample will reside after the sample is introduced into and fills the chamber. Larger formed constituents such as white blood cells in the sample are unable to enter the aforesaid lesser thickness region of the chamber. The red cells which reside in the greater thickness regions will agglomerate to form rouleaux and lacunea. The exact thickness of the chamber at any particular location in the chamber can be predetermined, or can be determined in situ as the sample is being analyzed.

Abstract: A method of evaluating a carbohydrate in a sample. The method includes providing a low valency carbohydrate binding ligand, providing a glycoconjugate which includes a label, and a carbohydrate moiety, contacting the low valency carbohydrate binding ligand and the glycoconjugate with the sample, determining the extent of binding of the low valency carbohydrate binding ligand with the glycoconjugate, the binding of the low valency carbohydrate binding ligand with the glycoconjugate being correlated with the amount of carbohydrate in the sample.

Abstract: The present invention provides a method for reducing undesirable light emission from a sample using at least one photon producing agent and at least one photon reducing agent (e.g. dye-based photon reducing agents). The present invention further provides a method for reducing undesirable light emission from a sample (e.g., a biochemical or cellular sample) with at least one photon producing agent and at least one collisional quencher. The present invention also provides a method for reducing undesirable light emission from a sample (e.g., a biochemical or cellular sample) with at least one photon producing agent and at least one quencher, such as an electronic quencher. The present invention also provides a system and method of screening test chemicals in fluorescent assays using photon reducing agents. The present invention also provides compositions, pharmaceutical compositions, and kits for practicing these methods.

Abstract: Method for specific detection of one or more analytes in a sample. The method includes specifically associating any one or more analytes in the sample with a scattered-light detectable particle, illuminating any particle associated with the analytes with light under conditions which produce scattered light from the particle and in which light scattered from one or more particles can be detected by a human eye with less than 500 times magnification and without electronic amplification. The method also includes detecting the light scattered by any such particles under those conditions as a measure of the presence of the analytes.

Abstract: The present invention provides a method for reducing undesirable light emission from a sample using at least one photon producing agent and at least one photon reducing agent (e.g. dye-based photon reducing agents). The present invention further provides a method for reducing undesirable light emission from a sample (e.g., a biochemical or cellular sample) with at least one photon producing agent and at least one collisional quencher. The present invention also provides a method for reducing undesirable light emission from a sample (e.g., a biochemical or cellular sample) with at least one photon producing agent and at least one quencher, such as an electronic quencher. The present invention further provides a method of determining bound and free analyte in a sample using at least one photon reducing agent. The present invention also provides a method of screening test chemicals in fluorescent assays using photon reducing agents.

Abstract: A micro-circuit for performing analyses of multimolecular interactions and for performing molecular syntheses, comprising: (a) a support; (b) at least one micro-electrode attached to the support, the micro-electrode being selectively electronically activated and the micro-electrode having a protective layer which is removable; (c) a binding entity for attachment to the at least one micro-electrode, the binding entity being capable of attachment to at least one micro-electrode when the protective layer has been removed; and (d) a power source being operatively connected to at least one micro-electrode for electronically activating at least one micro-electrode. The micro-circuit of the present invention also includes embodiments featuring a micro-circuit reader for detecting the interaction of the binding entity to a complementary probe, as well as methods for making and using the micro-circuit of the present invention.

Abstract: The present invention provides a method for reducing undesirable light emission from a sample using at least one photon producing agent and at least one photon reducing agent (e.g. dye-based photon reducing agents). The present invention further provides a method for reducing undesirable light emission from a sample (e.g., a biochemical or cellular sample) with at least one photon producing agent and at least one collisional quencher. The present invention also provides a method for reducing undesirable light emission from a sample (e.g., a biochemical or cellular sample) with at least one photon producing agent and at least one quencher, such as an electronic quencher. The present invention further provides a method of determining bound and free analyte in a sample using at least one photon reducing agent. The present invention also provides a method of screening test chemicals in fluorescent assays using photon reducing agents.

Abstract: The present invention relates to stable compositions useful as primary standards and calibrators and controls comprising a cardiac troponin I (cTnI) such as native, recombinant, addition and deletion forms thereof, whether or not complexed with other troponin subunits such as TnC and/or TnT, in an inactivated human serum. The compositions are obtained by incubating troponin complexes with human serum. The compositions are characterized by an immunodetectability ratio of epitopes on the N-terminal segment to epitopes on the C-terminal segment substantially equivalent to that of pooled, fresh serum from acute myocardial infarction patients.

Abstract: Disclosed is a diagnostic device for the colorimetric detection of an analyte in a test fluid. The device is a dry reagent layer which is overcoated with a transparent, fluid permeable membrane. The membrane is made up of a combination of a water dispersible and a water soluble polymer. The membrane may contain a surfactant and a thickener.

Abstract: The present invention provides a relatively accurate, rapid and economical method of screening a patient for the presence of inflammatory diseases such as an intraamniotic infection, bacterial meningitis and the sexually transmitted diseases; gonorrhea, chlamydia and trichomoniasis. The method of the present invention involves measuring the concentration of neutrophil defensins HNP1-3 and the concentration of lactoferrin, found in a bodily fluid, tissue or a combination thereof, adding these two concentrations together to yield a summed total, and correlating the measured summed total to known summed totals to give an indication of whether the patient is at risk of suffering from inflammatory diseases such as an intraamniotic infection, bacterial meningitis or the sexually transmitted diseases; gonorrhea, chlamydia and trichomoniasis.

Abstract: A sample is prepared from blood in a manner which makes it possible to further analyze proteins in the sample, e.g. to detect prions in the sample. Blood is extracted, allowed to clot and subjected to separation processing (e.g. centrifugation) to obtain serum. The serum is treated with a complexing agent which agent binds prions in the sample forming an agent/protein complex which makes it possible to concentrate the complex. Concentration of the complex results in a sample which can be successfully analyzed, e.g. assayed using a range of different types of assay methodologies for detecting prions.

Abstract: Electrochemiluminescent assay methods for determining an analyte of interest, which methods include forming one or more compositions which include, in the aggregate, (a) a sample to be tested for the analyte of interest, (b) a component capable of specifically binding with the analyte, (c) a label reagent which, when oxidized, is capable of electrochemiluminescence, (d) an amine which, when oxidized, forms a reducing agent, and (e) an electrolyte solution; subjecting such a composition containing the sample to conditions sufficient for specific binding to occur between the analyte of interest, if present, and one or more of the other components in the composition; thereafter, a composition containing the label reagent and amine, and reflecting the outcome of applying the aforementioned binding conditions, is exposed to conditions, such that both the label reagent and the amine are oxidized, the amine forms a reducing agent which interacts with the label reagent, electrochemiluminescence occurs, and the lumine