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.

Abstract: A metering tip for use in a clinical analytical apparatus includes a tapered body having at least one interior stepped areas. Each of the stepped areas include a sharp diametrical edge for latching a fluid meniscus being dispensed from the tip and for reducing fluid oscillation during metering.

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: An aqueous composition containing primers for opposing strands of human cytomegaloviral DNA and a second target DNA can be used in polymerase chain reaction to provide simultaneously rapid and efficient amplification and detection of those nucleic acids. The primers for each target DNA differ in length by no more than 5 nucleotides and have a Tm within the range of from about 65 to about 74° C., while the Tm's are within about 5° C. of each other. Such compositions are useful in diagnostic test kits and methods for amplification and detection of hCMV DNA and other target DNA's using multiple capture probes, in “multiplexing”. All of the capture probes have Tm's which are greater than 50° C. and are within 15° C. of each other.

Abstract: The present invention relates to methods for separating nucleic acids from other cellular debris, especially substances that carry a net positive charge at low pH, by electrophoresis under acid conditions. In the purification method of the present invention, nucleic acids are separated from proteins found in the same biological sample by applying the sample to an electrophesis gel and subjecting the sample to electrophoresis under acid conditions to separate the nucleic acids from the proteins. The optimum pH may differ for different sample types but can be readily determined by those skilled in the art. Preferably, the separation is performed at a pH of about 2 to about 4. More preferably, electrophoresis is carried out at a pH of 2.

Abstract: Evaporation control for a fluid supply, such as used in a clinical analyzer, can be provided by utilizing a straw-like insert which is disposed into a fluid-containing bottle. The straw provides an increased diffusion length or “stagnant” zone. The bottle can also be configured to effectively reduce evaporation in a similar manner by providing a narrowed diameter prior to the fluid retaining portion of the bottle and by increasing the distance between the top of the bottle and the top of the fluid surface.

Abstract: Apparatus and a method for mixing a liquid within a disposable aspirating probe tip so that most of the liquid is forced to move past a transition zone between two different inside diameters to cause rotational mixing. The apparatus and method can be used to provide agglutination of blood, which in turn can be used for blood typing. The probe tip can comprise a single integral piece, or two separate portions. The transition zone can comprise a sharp demarcation between inside diameters, or a smooth one.

Abstract: Described herein are methods and kits for the detection of hepatitis C virus RNA is biological samples obtained from human subjects. The invention includes novel amplification primers and probes useful in the amplification of DNA derived from hepatitis C virus RNA, and kits and methods which incorporate the novel primers.

Abstract: Disclosed herein are methods and kits for the simultaneous detection of hepatitis C virus and human immunodeficiency virus in biological samples from human subjects.

Abstract: An assay element for analyzing a charged analyte employs an immobilized receptor and a material having a net charge which is the same as that of the analyte. In a preferred embodiment, the analyte is an aminoglycoside and the material is a polymer having a net positive charge.