Abstract: The invention relates generally to both a method and apparatus for the creation of full resolution color digital images of diagnostic cassettes or objects of interest using a gray-scale digital camera or sensor combined with time sequential illumination using additive primary colors followed by post exposure digital processing. Such procedures and equipment is of significant economic value when employed in situations such as diagnostic clinical analyzers where space is limited and image quality requirements are high.

Abstract: A plurality of individual single column test elements are provided for use in a clinical testing apparatus. Each test element is defined by a single test column that includes a quantity of a test material, such as gel material or a bead matrix, including a cover strip used to access the contents of the test column. Individual test elements can be stored, retained and dispensed for testing patient samples.

Abstract: A networked clinical diagnostic analyzer is disclosed with support for monitoring by a remote back office. The disclosed analyzer includes a module to detect in real-time events of interest while allowing the back office to modify the definitions of the events. The module may be networked using virtual private networking into the back office network, which is usually different from the network at the site of the clinical diagnostic analyzer's deployment. The real-time alerts allow both a quick response to actual or expected error conditions and the downloading of logged data that is likely of most interest and relevance.

Abstract: Disclosed herein are compositions and methods comprising two or more proteins in which at least one of the proteins has been altered to reduce their mutual recognition and binding. Such compositions are useful as reference, calibrators or controls in methods and assays for determining the amount of one or more of the proteins that may be present in a sample of interest or in confirming the presence of one or more of the proteins in the sample. More particularly, it relates to compositions and methods comprising altered placental growth factor-1 (PlGF-1) and soluble fms-like tyrosine kinase (sFlt-1) and methods for determining the amount or confirming the presence of sFlt-1 and/or PlGF-1 in a sample of interest.

Abstract: Methods for determining the presence or amount of a complex comprising a first and second molecular entity are provided, preferably an sFlt-1:PlGF complex. A determination of the presence or amount of the complex can be used in methods for predicting, detecting, monitoring a disease, or guiding therapy in respect to a disease such as vascular, vascular-related disease, cardiac, cardiac-related disease, cancer, cancer-related disease, preeclampsia, and preeclampsia-related disease. Determining sFlt-1:angiogenic factor complex is particularly useful for predicting and detecting preeclampsia in early stages of gestation and in stages of the disease where clinical evaluation may be uninformative.

Abstract: An assay device includes: a liquid sample zone; a reagent zone downstream and in fluid communication with the sample zone containing a reagent material; a detection zone in fluid communication with the reagent zone having capture elements bound thereto; and a wicking zone in fluid communication with the capture zone having a capacity to receive liquid sample flowing from the detection zone. The sample receiving zone, the reagent zone, the detection zone and the wicking zone define a fluid flow path and at least a part of the fluid flow path has a substrate and projections which extend substantially vertically from the substrate, wherein the projections have a height, cross-section and a distance between one another that defines a space between the projections capable of generating capillary flow parallel to the substrate surface. In addition, the fluid flow path having projections includes a corner section which changes the direction of the flow path.

Abstract: Methods for determining the presence or amount of a complex comprising a first and second molecular entity are provided, preferably an sFlt-1:PlGF complex. A determination of the presence or amount of the complex can be used in methods for predicting, detecting, monitoring a disease, or guiding therapy in respect to a disease such as vascular, vascular-related disease, cardiac, cardiac-related disease, cancer, cancer-related disease, preeclampsia, and preeclampsia-related disease. Determining sFlt-1:angiogenic factor complex is particularly useful for predicting and detecting preeclampsia in early stages of gestation and in stages of the disease where clinical evaluation may be uninformative.

Abstract: The invention relates generally to an apparatus and method that enables a very accurate initial setup of the coating gap for slot die coater and subsequent control of the coating gap during coating operations such that web splices and web defects do not interrupt the coating process. An highly accurate initial set up is achieved via the use of a tapered or wedge-shaped adjustment member mounted perpendicular to the axis of travel of the coating head where the movement of this tapered or wedge-shaped adjustment member in a direction perpendicular to the axis of travel of the slot die housing adjusts the coating gap in increments on the order of ten microns.

Abstract: The invention relates to compounds of Formula I, wherein R1, R2, and R3 are defined in the specification, useful for the synthesis of novel conjugates and immunogens derived from quetiapine. The invention also relates to conjugates of a quetiapine hapten and a protein.

Abstract: The invention relates to compounds of Formula I, wherein R1, R2, and R3 are defined in the specification, useful for the synthesis of novel conjugates and immunogens derived from olanzipine. The invention also relates to conjugates of an olanzipine hapten and a protein.

Abstract: The invention relates to compounds of Formula I, wherein L1, L2, and L3 are defined in the specification, useful for the synthesis of novel conjugates and immunogens derived from paliperidone. The invention also relates to conjugates of a paliperidone hapten and a protein.

Abstract: An assay device includes: a liquid sample zone; a reagent zone downstream and in fluid communication with the sample addition zone containing a reagent material; a detection zone in fluid communication with the reagent zone. The detection zone has a substrate and projections which extend substantially vertically from the substrate, wherein the projections have a height, cross-section and a distance between one another that defines a capillary space between the projections capable of generating capillary flow parallel to the substrate surface. The device is capable of creating a reagent plume in the detection zone that includes liquid sample and dissolved reagent, where the width of the reagent plume extends substantially across the width of the detection zone, The device further includes a wicking zone in fluid communication with the detection zone having a capacity to receive liquid sample flowing from the detection zone.

Abstract: A Treponema pallidum triplet antigen construct is disclosed which includes three Treponema pallidum antigens (TP15, TP17, and TP47), as well as a ten amino acid leader sequence (tag 261) and human copper zinc superoxide dismutase (hSOD). This construct is optimized for in vitro diagnosis of syphilis infection. Plasmids containing DNA encoding the triplet antigen, host cells, production methods, detection methods, and kits are also disclosed.

Abstract: An immunodiagnostic test method includes holding a selection of immunological test elements or consumables in one or more containers attached to or positioned in the analyzer and providing random access to any test element therein. The container can hold multiple types of test elements in compartments or slots. Through sensing of a test element position in its slot, the detection mechanism of the invention provides for random access to multiple types of test elements in any sleeve and within a single sleeve, and provides efficient inventory control. The method increases the number of test element types that may be loaded onto an analyzer and maintains fast determination of inventory.

Abstract: The invention relates to compounds of Formula I, wherein R1, R2, and R3 are defined in the specification, useful for the synthesis of novel conjugates and immunogens derived from aripiprazole. The invention also relates to conjugates of an aripiprazole hapten and a protein.

Abstract: An immunodiagnostic test method includes holding a selection of immunological test elements or consumables in one or more containers attached to or positioned in the analyzer and providing random access to any test element therein. The container can hold multiple types of test elements in compartments or slots. Through sensing of a test element position in its slot, the detection mechanism of the invention provides for random access to multiple types of test elements in any sleeve and within a single sleeve, and provides efficient inventory control. The method increases the number of test element types that may be loaded onto an analyzer and maintains fast determination of inventory.

Abstract: The invention relates to compounds of Formula I, wherein R1 and R2 are defined in the specification, useful for the synthesis of novel conjugates and immunogens derived from risperidone and paliperidone. The invention also relates to conjugates of a risperidone or paliperidone hapten and a protein.

Abstract: A method for providing quality control on a lateral flow assay device or for triggering a process-related step, the device including a substrate having at least one sample receiving area, at least one reagent zone downstream and in fluid communication with the at least one sample receiving area, at least one detection zone downstream and in fluid communication with the at least one reagent zone and at least one wicking zone downstream of the at least one detection zone, each fluidly interconnected therewith along at least one fluid flow path. The detection material provided in the at least one reagent zone produces a detectable signal that can be tracked and monitored prior to the completion of at least one test being performed on the lateral flow assay device.

Abstract: The invention relates generally to both a method and apparatus for the creation of full resolution color digital images of diagnostic cassettes or objects of interest using a gray-scale digital camera or sensor combined with time sequential illumination using additive primary colors followed by post exposure digital processing. Such procedures and equipment is of significant economic value when employed in situations such as diagnostic clinical analyzers where space is limited and image quality requirements are high.