Abstract: The present invention describes peptides and recombinant proteins containing Hepatitis C virus core protein sequence in which one or more of the amino acids have been modified or deleted to remove the ability of these proteins to bind to specific anti-HCV murine monoclonal antibodies. The deletions and modifications are designed as to maintain the ability of this protein to be used in immunoassays used for the detection of anti-HCV antibodies in individuals infected with HCV.

Abstract: An incubator includes an incubator ring assembly having at least two concentric rings supported for rotation about a common axle defining an axis of rotation. Each concentric ring includes a plurality of circumferentially defined load positions, each load position being sized for accommodating a test sample. At least one test station is arranged in relation to the plurality of load positions to selectively test a test sample, the test samples being are sequentially shuttled into and out of load positions of at least one of the concentric rings to increase the overall throughput of the analyzer.

Abstract: A method for measuring the presence or concentration of an analyte in a sample by spectrophotometry: providing an open top cuvette having a sample with an analyte to be measured; providing a light source and a detector for detecting emitted light; taking at least two measurements that includes: (i) directing at least two beams of light from the light source to different locations on the cuvette; (ii) passing the at least two beams through the cuvette at their respective locations and through the sample to be measured; and (iii) measuring at least two respective emitted light beams with the detector; and comparing the at least two emitted light beams to determine if: all the emitted light beams should be disregarded; one or more of the emitted light beams should be disregarded; or the sample absorbances should be averaged. In a preferred embodiment, the method includes taking at least three measurements.

Abstract: A method for measuring the amount of fluid contained in a reaction vessel in a clinical analyzer includes the steps of adding a first aliquot of fluid to the reaction vessel and measuring the quantity of fluid contained therein. A second aliquot of fluid is then added to the reaction vessel and the quantity of fluid contained therein is also measured. Measurement of the two fluid quantities can occur with or without removal of the first aliquot in between measurements. In obtaining the two quantity measurements and comparing them against a standard, the effects of well geometry can be minimized. Preferably, a delta or ratio measurement is obtained between the first and second liquid volume measurements which can be compared against a standard so as to normalize apparent volume losses or gains due to reaction well dimensional variation. This approach enhances the analytical capability to detect true fluid delivery errors.

Abstract: Nucleic acids can be made available for amplification or other treatment after admixture of a sample with specific weakly basic polymers to form a precipitate with the nucleic acids at acidic pH. After removing non-precipitated materials, the pH is then made basic, thereby releasing the nucleic acids from the polymer. This method for preparing specimen samples is simple and quite rapid, and the released nucleic acids can be further treated in hybridization assays or amplification procedures. No surfactant or other cell lysing reagents are employed. The weakly basic polymers are water-soluble and cationic at acidic pH, but neutral in charge at basic pH.

Abstract: A system for detecting and analyzing patient sample quality and/or analytes, while the sample is in the metering tip used to aspirate the sample liquid from an original patient sample container, and also to dispense the liquid onto a slide test element. Spectrophotometric analysis may be done on the sample liquid while it is still in the tip which has been converted into a cuvette. One technique for such analysis is by scanning the cuvette for transmittance in a light-tight enclosure. Near-infrared and adjacent visible radiation may be used, and the absorption spectra of the liquid detected and analyzed. A possible aspect of the present invention relates to enhancing throughput of an analyzer by conducting a sample quality measurement in a process that is parallel to the main analyzer timing cycle.

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: A method of transporting a desired fluid in a channel includes: providing a working fluid to transport the desired fluid, such as a sample; providing a first segment of a first buffer fluid which is immiscible with the working fluid and the desired fluid; providing a first segment of the desired fluid; providing a second segment of a second buffer fluid which is immiscible with the working fluid and the desired fluid; providing the desired fluid to be transported and further manipulated; and transporting the desired fluid in the channel by applying a motive force to the working fluid which in turn exerts force against the desired fluid through the first and second buffer fluid. The method prevents dilution of a sample in an apparatus such as a diagnostic analyzer or an apparatus for immunohematological testing of blood. A microfluidics handling system includes a microsystem platform that has: a substrate having: a first flat, planar surface; and a second flat planar surface opposite to the first surface.

Abstract: An apparatus for determining the volume of liquid in a probe tip of an aspirating or dispensing probe, such as those used in a diagnostic analyzer, includes: two electrodes on opposite sides of the probe tip and the electrodes and liquid form a variable capacitor; a resistor; a voltage source and the electrodes and resistor are in electrical communication in at least one of series, parallel or series and parallel to form an RC circuit; and a microprocessor in electrical communication with the RC circuit for converting an electrical signal to a volume of liquid in the probe tip. In a preferred embodiment, the probe tip is separate from the probe and is adapted to be fitted on the end of a probe for aspirating and dispensing a liquid.

Abstract: Methods for producing biological solutions such as immunoglobulins and in particular anti-D immunoglobulin substantially free of abnormal prion protein resulting therefrom. Specifically provided are methods for aggregation of prions and depth filtration of the biological solution to capture and remove abnormal and if desired, normal prion protein. The prion protein may then be eluted from the depth filter and filter washes and concentrated sufficient for detection at limits currently required by available assays.

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 least one 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: The invention provides a lens in which the lens periphery is controlled as to each of thickness differential and both the rate of change from thinner to thicker regions and the shape of the transition from thinner to thicker regions within each of the dual thin zones. The lens of the invention substantially reduces the time for the lens' auto-positioning. Additionally, the lenses of the invention maintain their on-eye orientation better as compared to conventionally stabilized lenses.

Abstract: We isolated and characterized a new surface mutant of the hepatitis B virus surface antigen (HBsAg). The mutant was isolated from a symptomatic patient with Down's syndrome who was found to be persistently positive for both for HBsAg and anti-HBs Antibody (Ab) with an equally long-lasting anti-HB core (c) IgM Ab.

Abstract: Monoclonal antibodies that specifically bind to HCV core antigen. Also provided are hybridoma cell lines which secrete these antibodies, methods for making and using these antibodies, including kits that include these antibodies.

Abstract: Simultaneous forward and reverse blood group testing is described using both a visual detection system and a fluorescent based labeling and detection system. Forward and reverse tests could be performed separately, but A and B agglutinates can be detected and discriminated simultaneously.

Abstract: A method for calibrating a clinical analyzer having a dispenser, and for automatically aligning the dispenser of the clinical analyzer includes loading a calibration element at a portion of the clinical analyzer; moving a dispenser of the clinical analyzer in a pre-determined direction (Y) to a position over the calibration element; measuring the height (Z) from the dispenser to the calibration element and determining a position coordinate (Yi, Zi); storing the position coordinate (Yi, Zi); determining a maximum height (Zmax) for the dispenser positioned over the calibration element defined as position coordinate (Yopt, Zmax); and storing the position coordinate including the maximum height (Zmax) for the dispenser positioned over the calibration element.

Abstract: A method for improving the fluid dispense rate in a metering system utilizing speed includes the steps of modifying the fluid flow rate profile during a portion thereof so as substantially increase or decrease the speed of the motor during certain portions of a metering cycle in order to improve the efficiency of the metering system. For a variable speed pump producing a sinusoidal speed profile, the pump motor speed can be increased to increase the dispense velocity during the beginning and end of the dispense phase to reduce perfusion and improve metered volume precision or a motor speed profile can be applied which is inverted relative to that of the variable speed pump to produce a constant velocity flow. Alternately or in addition to the above, the home position of the variable speed pump can be shifted to produce fluid velocity during the entirety of a dispense portion of a metering system cycle.

Abstract: The present invention relates to new CRP immunoassay compositions. The compositions include a low affinity anti-human CRP monoclonal antibody, and an antiidiotypic antibody raised against it. The invention further provides a method for obtaining antiidiotypic monoclonal antibody populations directed to an antibody that is specific for a high concentration, high molecular weight target antigen.

Abstract: A system for detecting and analyzing patient sample quality and/or analytes, while the sample is in the metering tip used to aspirate the sample liquid from an original patient sample container, and also to dispense the liquid onto a slide test element. Spectrophotometric analysis may be done on the sample liquid while it is still in the tip which has been converted into a cuvette. One technique for such analysis is by scanning the cuvette for transmittance in a light-tight enclosure. Near-infrared and adjacent visible radiation may be used, and the absorption spectra of the liquid detected and analyzed. A possible aspect of the present invention relates to enhancing throughput of an analyzer by conducting a sample quality measurement in a process that is parallel to the main analyzer timing cycle.

Abstract: A spectrophotometric assay for the detection of acetaminophen in aqueous fluids is carried out with a dry analytical element. The element comprises a support having thereon one or more reagent layers containing a first enzyme, aryl acylamidase, to cleave the amide bond of acetaminophen to produce p-aminophenol; and a mild oxidizing agent to oxidize the p-aminophenol so that it couples to a water-soluble coupling agent to form a dye that is read at 670 nm. The assay is precise, accurate on serum and plasma samples, and relatively free from significant interferences. The element also allows measurement over a broad dynamic range.