Abstract: The invention is a method for detecting failures in an analyzer for conducting clinical assays. Potential errors that can result in assay failures in an analyzer are identified, as are their potential sources. The probability that an error source so identified will result in a clinically significant error is also determined. Available potential detection measures corresponding to the source of potential errors are identified with a combination of such measures selected and implemented based on their probability of detecting such errors within an acceptable limit with a concomitant low probability of the false detection of an assay failure. Each of the measures selected are functionally independent of others chosen to address the source of the error and are not subject to the same inherent means of failed detection. Applications of the method in a clinical analyzer are also presented.

Abstract: Aspirating a liquid, includes: providing an aspirating probe comprising probe tip and piston pump, wherein the probe tip and piston pump are in fluid communication; measuring an initial gas pressure in the probe prior to liquid entering the liquid being aspirated; moving the tip into the liquid; moving the piston a distance corresponding to the volume of liquid being aspirated; measuring gas pressure in the volume of gas when the piston stops moving and the liquid pulled into the tip has equilibrated; determining piston volume created by movement of the piston; and determining volume of liquid aspirated by the following formula: Vliquid aspirated=Vpiston volume?((Pinitial?Pfinal)*Volume/unit pressure), wherein Pinitial is initial gas pressure before liquid enters the tip, Pfinal is the final pressure of volume of gas after the liquid has equilibrated, and Volume/unit pressure is the change of gas volume for each change of unit pressure.

Abstract: The Epstein-Barr virus (EBV) specific polypeptides ETFTETWNRFITHTE (SEQ. ID NO: 1), GMLEASEGLDGWIHQ (SEQ. ID NO:2), HQQGGWSTLIEDNIP (SEQ. ID NO:3), and KQKHPKKVKQAFNPL (SEQ. ID NO:4) are among those disclosed. Also disclosed are the use of these polypeptides for the production of polypeptide-specific antibodies and the diagnosis and treatment of EBV-associated disease.

Abstract: An ultrasonic, non-invasive, bottom-up fluid level sensor for a container, includes: an ultrasonic transducer; and a dry couplant in acoustic communication with the transducer. The dry couplant is configured to adapt to the bottom surface of the container and the sensor contains nothing to bias the sensor against the container other than the weight of the container and fluid.

Abstract: An apparatus and a related method for performing particle agglutination reactions in at least one disposable probe tip are disclosed. The at least one probe tip includes a sample cavity for sample acquisition, at least one flanking cavity for the capture of particles by centrifugation or other means, a transition zone for the mixing of the sample with reagents for agglutination and a detection zone for the optical detection of particle agglutination. A mechanism may be attached to the probe tip for the controlled movement of fluids through the internal volume of the probe tip. The probe tip is particularly useful for the automation of high-throughput agglutination-type assays.

Abstract: A detection/determination kit with which a substance to be detected or the amount thereof can be rapidly, inexpensively, and easily detected or determined; and a detection/determination method. The kit, which is for detecting a substance to be detected (50) contained in a specimen, comprises: a first compound (10) comprising a first substance including a stimulus-responsive polymer (11) and, bonded to the first substance, a first antibody (13) against the substance (50); and a second compound (20) comprising a second substance (21) which is hydrophilic and, bonded thereto, a second antibody (23) against the substance (50). The first antibody (13) and second antibody (23) can simultaneously combine with the substance (50) at different sites in the substance (50).

Abstract: A method for positioning a sample in a diagnostic analyzer includes: providing two or more sample carriers on a conveyor; providing a fixed registration element for each sample carrier at predetermined locations along the conveyor; providing a flexure device positioned between the sample carrier and the conveyor; advancing the sample carrier beyond the fixed registration elements; reversing the conveyor direction to back at least one of the sample carriers into contact with its corresponding registration elements; continuing to reverse the conveyor until all sample carriers are in contact with their respective registration elements; whereby the flexure elements of the sample carriers in contact with the respective registration elements will deform as the conveyor reverses to allow all sample carriers to contact their respective registration elements, thereby providing a known position of the sample carrier.

Abstract: It is intended to provide a detection method and a determination method for detection target capable of detecting and determining a detection target promptly and simply with high accuracy at low cost. The detection method includes the steps of: mixing a first conjugate 10 in which a first substance containing a stimulus-responsive polymer 11 and a particulate magnetic substance 19 is conjugated to a first antibody 13 against a detection target 50 with a sample; applying a magnetic force after placing the resulting mixture in a condition capable of aggregating the stimulus-responsive polymer 11; measuring a generated magnetic field; and detecting the detection target 50 based on the degree of increase in the magnetic field after applying the magnetic force.

Abstract: A clinical analyzer for determining the presence or amount of an analyte in a sample includes at least one reagent supply and at least one reaction containment device for containing a volume of sample and a volume of said at least one reagent from said at least one reagent supply. A wash-free delivery system introduces reagent into at least one reaction containment device without requiring washing of delivery components.

Abstract: An apparatus and a related method for performing particle agglutination reactions in a single, disposable probe tip are disclosed. The probe tip includes a sample cavity for sample acquisition, at least one flanking cavity for the capture of particles by centrifugation or other means, a transition zone for the mixing of the sample with reagents for agglutination and a detection zone for the optical detection of particle agglutination. A mechanism may be attached to the probe tip for the controlled movement of fluids through the internal volume of the probe tip. The probe tip is particularly useful for the automation of high-throughput agglutination-type assays.

Abstract: A closure for a container includes: (a) an inner cylindrical wall having first and second ends and defining a space; (b) an outer cylindrical wall opposite the inner cylindrical wall and having the first and second ends to form an outer surface of the closure; (c) a first end wall extending across said first end, wherein the first end wall comprises a recess extending a least partially into the space, and a first set of threads disposed on the recess. An apparatus usable on a diagnostic analyzer container and includes: a threaded rotatable spindle adapted for threading into a closure having a threaded depression and for applying a rotational force to remove the closure; and a clutch having an element adapted to engage the closure and apply a rotational to the closure.

Abstract: A method of analyzing a sample for one or more analytes of interest includes: providing an element having a base layer; a layer containing streptavidin; a spreading layer, wherein the streptavidin may or may not be in the spreading layer; providing immunocomponents and labeled immunoreactants which may be in the spreading layer or may be combined with the sample; dispensing the sample, and optionally the immunocomponents and a labeled immunoreactant onto the spreading layer at three or more areas, wherein each center of the three or more areas is substantially equidistance to the center formed by the three or more areas, and wherein each area contacts an adjacent area such that wash fluid flow in any direction will contact sample; washing the sample and label by directing the wash fluid at the center formed by the three or more areas, whereby the wash fluid equally flows over each of the three or more areas; and taking a measurement at each three or more areas to determine the presence or concentration of the

Abstract: The aim of the present invention is to provide a non-intrusive way to isolate, concentrate and monitor the TSE disease-related pathogenic prion protein. The invention described several peptides and their ability to capture PrPSc from brain homogenate of prion disease infected animal and human. These eight peptides do not capture cellular prion protein from individual with no prion disease.

Abstract: A centrifuge includes: a plurality of centrifuge discs each disc having an attachment for attaching a container containing a liquid to be centrifuged; a disc driver positioned to engage and rotate the discs; a disc engager/disengager for individually moving each of said discs into and out of contact with the disc driver; and a controller for controlling which discs are engaged or disengaged from the disc driver and the amount of time each disc is centrifuged. In another embodiment, the centrifuge includes a plurality of disc drivers positioned to engage and rotate the discs, wherein the rotation of discs are controlled by the plurality of disc drivers; and a controller for controlling which discs are rotated by the plurality of disc drivers and the amount of time the discs are centrifuged by individually controlling each disc driver.

Abstract: A device for heating or cooling multiple single chamber containers or a multi-chamber container. The device includes: a unitary heat or cold source providing a source of heat or cold; heat exchange elements in thermal communication with the heat or cold source and extending away from the heat or cold source; a thermal barrier between each of said heat exchange elements to thermally isolate the heat exchange elements from each other. Each heat exchange element is thermally associated with one or more chambers that are different from one or more chambers associated with other heat exchange elements to thermally isolate the chambers from each other. Preferably the container is a sample or reagent container used in a clinical analyzer, such as a multi-chamber reaction cuvette or a multi-chamber microtiter plate. An incubator assembly, preferably usable in a clinical analyzer, can include the device for heating or cooling.

Abstract: A method for quantitatively measuring error causing physical parameters in a fluid handling system, includes: measuring the pressure of air between a piston of a pump and a liquid being handled; detecting a pressure abnormality; determining the time at which the pressure abnormality begins to occur; and based on the time of the pressure abnormality determining the magnitude of the physical parameter causing the pressure abnormality. In a preferred embodiment, the error causing physical parameter is a bubble and the fluid handling is an aspirate operation in a diagnostic analyzer.

Abstract: An apparatus for classifying a liquid patient sample includes at least one sample container having a quantity of a sample that is aggressively acted upon so as to create a flow field. A measurement mechanism includes at least one low angle light emitter aligned with a measurement window of the at leas tone sample container and a detector oppositely disposed relative to the measurement window. Measurement of the scattered light detects particle characteristics of a moving flow field from the sample to determine, for example, the amount of agglutination of the sample so as to perform blood typing or other classifications without spatial separation.

Abstract: Disclosed are a detection/quantification kit and a detection/quantification method for detecting/quantifying an analyte rapidly at a low cost and in a simple manner. Specifically, disclosed is a kit for detecting an analyte in a sample, comprising a first conjugate and a second conjugate, wherein the first conjugate comprises a first substance comprising a stimuli-responsive polymer and a first affinity substance having affinity for the analyte and bound to the first substance, and the second conjugate comprises a second substance carrying an electrical charge and a second affinity substance having affinity for the analyte and bound to the second substance. The first and second affinity substances can bind to different sites on the analyte simultaneously.

Abstract: The solvent-detergent (S/D) process is used to inactivate enveloped viruses in plasma products. While concentrations of 1.0% detergent and 0.3% tri-n-butyl phosphate solvent have been considered necessary for robust removal of viral activity, we show the effectiveness of solvent-detergent treatment after fractionation and nanofiltration of an immune gamma globulin preparation, which required significantly reduced concentrations of solvent and detergent. Reduced levels of solvent and detergent lead to greater efficiencies in their removal post-inactivation with the potential for greater yields and decreased processing costs.

Abstract: A fluid aspirating/dispensing member includes a sample cavity for sample acquisition and a sealable cavity that, once sealed, permits the separation of particles from the remainder of a fluid sample within the sample cavity after centrifugation or other separation means. The fluid aspirating/dispensing members, either individually or as part of an array, increase the efficiency of sample processing before analysis by a clinical analyzer.