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 assay device includes a support, test elements arranged thereover, and a diverter defining a common sample addition area of the device. The diverter conducts respective portions of a fluidic sample from the area to each of the test elements. Another assay device includes the test elements, one a dry slide element, disposed over the support at least partly in proximity to each other to define a common sample addition area. Apparatus for analyzing a sample includes an assay device having the test elements, one a dry slide element. A controller operates a metering mechanism, to apply the sample to the assay device, an incubator, and a measurement device per a timing protocol to determine a characteristic of the sample. Methods for enabling an assay device to perform multiple tests based upon a single sample metering event include are also described.

Abstract: A method for performing an assay on a liquid sample for the detection of one or more analytes of interest in an assay device having a flow path which includes a sample zone and detection zone thereon includes: dispensing the sample onto the sample zone; combining the sample and a reagent, wherein the sample and reagent may be combined prior to addition of the sample to the sample zone or on the assay device, flowing the combined sample/reagent by capillary action into and through the detection zone having capture elements bound thereto, wherein a signal at least partially representative of the presence or concentration of analyte(s) is produced and detected; determining a reaction time or reaction volume; and determining the concentration of the analyte by using both the detected signal and the reaction time or reaction volume.

Abstract: An order management system including a server including a processor, a network interface for communicating with at least one medical device having an associated plurality of consumables, data storage means for storing relationship information for each consumable, current inventory for each consumable, usage history for each consumable, and an order management module including program instructions that, when executed by the processor, are configured to calculate consumable order information based on the relationship information, current inventory, and usage history for each consumable.

Abstract: An assay device includes: a liquid sample zone; a reagent zone downstream and in fluid communication with the sample zone that includes a reagent cell having a line of symmetry in the direction of fluid flow; a reagent material in the reagent cell, wherein the reagent material includes a first reagent material located at the axis of symmetry and is left-right symmetric, and a second and third reagent material having a substantially identical shape and volume and located in mirror locations from the line of symmetry; a detection zone in fluid communication with the reagent zone; and a wicking zone in fluid communication with the detection zone having a capacity to receive liquid sample flowing from the detection zone. The sample addition zone, the detection zone and the wicking zone define a fluid flow path.

Abstract: A sample collection device for a fluid includes: a substantially disk-shaped body having a periphery; a capillary channel extending through the body and bounded by the periphery, having a first end and a second end, wherein the first end is adapted to draw the fluid into the channel by capillary action; a sample collection well located in the vicinity of the second end and in fluid communication with the capillary channel; and an axis of rotation extending through the center of the disk and which is substantially perpendicular to the major surface of the disk-shaped body. In a preferred embodiment, the sample collection device is adapted to rotate about the axis of rotation within a cartridge having a housing comprising an air vent in fluid communication with the capillary channel when the disk is rotated in a first position.

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: A method for determining a condition in a blood sample includes: providing a sample of blood; providing a metering probe having a pump for aspirating and dispensing; inserting the metering probe a selected distance into the blood sample; measuring the pressure between the sample and pump during sample aspiration or sample dispense; comparing the measured pressure with a reference value; and signaling the presence or absence of the condition. A method for confirming or detecting the presence of a selected layer of blood component in a centrifuged blood sample includes: measuring a pressure of a suspected selected layer in a metering probe during aspiration or dispense; comparing the measured pressure with a reference value, wherein if the measured pressure and the reference value are substantially identical then the selected layer of the blood component is confirmed. In a preferred embodiment the reference value is a pre-selected pressure range.

Abstract: A lateral flow device for use in a mainframe or point-of-care clinical analyzer, in which the lateral flow device includes a planar support having at least one sample addition area and at least one reaction area disposed thereon. The sample addition area and reaction area are fluidly interconnected to one another and form at least one lateral fluid flow path. The lateral flow device is sized for retention within a storage cartridge of the analyzer defined by a hollow interior and having a plurality of lateral flow assay devices retained in stacked relation therein.

Abstract: An assay device includes: a liquid sample zone; a reagent zone downstream and in fluid communication with the sample zone. The reagent zone includes at least two reagent cells containing a reagent material and arranged in the reagent zone such that each reagent cell experiences substantially the same flow conditions of sample from the sample zone. The reagent cells divide the sample flow from the sample zone into multiple flow streams. Also includes are: one or more flow control elements disposed downstream from the reagent zone which combine the multiple flow streams into fewer flow streams; a detection zone in fluid communication with the reagent zone; and a wicking zone in fluid communication with the detection zone having a capacity to receive liquid sample flowing from the detection zone. The sample addition zone, the detection zone and the wicking zone define a fluid flow path.

Abstract: A sample collection device for a fluid sample includes: a body including a capillary channel having a first end and a second end, wherein the first end is adapted to draw the fluid into the channel by capillary action; an air vent located in the vicinity of the second end and in fluid communication with the capillary channel; a barrier positioned within the capillary channel to prevent flow of the fluid by capillary action thereacross; and features on opposing sides of the body to form an axis of rotation, which is substantially perpendicular to the overall direction of the capillary channel from the first end to the second end. In a preferred embodiment, the sample collection device is adapted to rotate about the axis of rotation within a cartridge having a sample manipulation device to bring the first end into position with the sample manipulation device.

Abstract: A lateral flow device for use in a mainframe or point-of-care clinical analyzer, in which the lateral flow device includes a planar support having at least one sample addition area and at least one reaction area disposed thereon. The sample addition area and reaction area are fluidly interconnected to one another and form at least one lateral fluid flow path. The lateral flow device is sized for retention within a storage cartridge of the analyzer defined by a hollow interior and having a plurality of lateral flow assay devices retained in stacked relation therein.

Abstract: An assay device includes: a liquid sample receiving zone; a capture zone in fluid communication with the sample receiving zone having capture elements bound thereto, the capture zone having a substrate and projections which extend substantially vertically from the substrate, the projections having a rhombus-shaped cross-section and the projections arranged on the substrate with the corners of the projections facing upstream in a direction toward the sample receiving zone. 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; and a sink in fluid communication with the capture zone having a capacity to receive liquid sample flowing from the capture zone. The sample receiving zone, the capture zone and the sink define a fluid flow path. Preferably, the rhombus-shaped cross-section is a square or a diamond.

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: A method for determining a condition in a blood sample includes: providing a sample of blood; providing a metering probe having a pump for aspirating and dispensing; inserting the metering probe a selected distance into the blood sample; measuring the pressure between the sample and pump during sample aspiration or sample dispense; comparing the measured pressure with a reference value; and signaling the presence or absence of the condition. A method for confirming or detecting the presence of a selected layer of blood component in a centrifuged blood sample includes: measuring a pressure of a suspected selected layer in a metering probe during aspiration or dispense; comparing the measured pressure with a reference value, wherein if the measured pressure and the reference value are substantially identical then the selected layer of the blood component is confirmed. In a preferred embodiment the reference value is a pre-selected pressure range.

Abstract: An immunodiagnostic test element includes a support member, at least one test column containing a test material, and a wrap, such as an adhesively-attached foil wrap, covering the top of the at least one test element. The wrap includes a weakened portion directly above each test column, in which each weakened portion is formed by pre-stressing the portion, but not to the point of puncturing the wrap to enable the wrap to be punctured by a fluid aspirating/dispensing element, such as a metering tip, permitting access to the contents of the test column.

Abstract: Disclosed is an antibody which binds to quetiapine, which can be used to detect quetiapine in a sample such as in a competitive immunoassay method. The antibody can be used in a lateral flow assay device for point-of-care detection of quetiapine, including multiplex detection of aripiprazole, quetiapine, olanzapine, and risperidone in a single lateral flow assay device.

Abstract: A plurality of individual single column test elements are provided for use in a clinical testing apparatus in an open-topped cartridge in which 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. The number of individual test elements provided in a cartridge can be varied, depending on the test(s) to be performed.

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: Disclosed is an antibody which binds to quetiapine, which can be used to detect quetiapine in a sample such as in a competitive immunoassay method. The antibody can be used in a lateral flow assay device for point-of-care detection of quetiapine, including multiplex detection of aripiprazole, quetiapine, olanzapine, and risperidone in a single lateral flow assay device.