Abstract: An apparatus, vortex generator assembly and method for automated cell lysis and nucleic acid purification and processing. The vortex generator assembly includes sample holder having a lysis well, at least one wash well, and an elution well. The vortex generator assembly also includes a sample holder cover having a plurality of vibration rods for creating a vortex in the wells of the sample holder. The apparatus includes motor operating a rotating cam to cause the vibration rods to vibrate and create the vortex in a well holding fluid and magnetic beads, wherein the vortexing speed is sufficient to overcome the magnetic attraction between the beads and disperse the beads in solution, to collect nucleic acids such as DNA.

Abstract: The present invention pertains to the field of coagulation diagnostics and relates to a prothrombin time reagent on the basis of recombinant or native tissue factor protein and phospholipids, which reagent can be stabilized by the addition of an iron chelator from the groups of siderophores and 3,5-diphenyl-1,2,4-triazoles.

Abstract: Absorbance spectroscopy methods and systems are disclosed including a spectroscopy analyzer, comprising: an optical element device positioned to receive an analysis light that passes through a sample of a fluid specimen from an illumination unit, the analysis light including first light in a first light range and second light in a second light range different than the first light range, the optical element device comprising: a housing assembly that defines an internal space; and a dichroic mirror-reflector within the internal space positioned to receive the analysis light, the dichroic mirror-reflector configured to filter the analysis light such that a first portion of the analysis light in the first light range is reflected off the dichroic mirror-reflector as a spectrometer light, and such that a second portion of the analysis light in the second light range passes through the dichroic mirror-reflector as a detector light.

Abstract: Methods of visualizing performance of a diagnostic laboratory system are provided. The methods include displaying on a display, an image representing a layout of a plurality of laboratory analyzers included within the diagnostic laboratory system, and overlaying the image with a dynamically-changeable color overlay that indicates a performance for the plurality of laboratory analyzers over a period of time via using changeable colors. Systems including color-changeable overlays are provided as are other aspects.

Abstract: A method of characterizing a serum or plasma portion of a specimen in a specimen container includes capturing a plurality of images of the specimen container from multiple viewpoints, stacking the multiple viewpoint images along a channel dimension into a single stacked input, and processing the stacked input with a single deep convolutional neural network (SDNN). The SDNN includes a segmentation convolutional neural network that receives the stacked input and outputs multiple label maps simultaneously. The SDNN also includes a classification convolutional neural network that processes the multiple label maps and outputs an HILN determination (Hemolysis, Icterus, and/or Lipemia, or Normal) of the serum or plasma portion of the specimen. Quality check modules and testing apparatus configured to carry out the method are also described, as are other aspects.

Abstract: Embodiments of the present invention are in the field of blood coagulation diagnostics and relate to a test for establishing an individual's blood coagulation system status based on the amount of in-vitro-generated F1+2 peptide, and to a test kit for use in such a method.

Abstract: There is provided a chloride selective membrane including an epoxide-based matrix reacted with a stoichiometric amount of an amino compound and an activator such that the epoxide-based matrix comprises a number of quaternary ammonium groups.

Abstract: An embodiment is a sample rack system. The sample rack system comprises a rack having a base, a top opposite the base along a vertical direction, a receptacle that extends from the top toward the base along the vertical direction, and a receiver element proximate the top. The receptacle is sized to receive a sample collection unit. The system also includes a retention clip for holding the sample collection unit in the receptacle. The retention clip includes an engagement head for attachment to the receiver element of the rack. The engagement head defines an outer surface. The retention clip also includes a curved tail that extends from the engagement head and contacts the sample collection unit when the sample collection unit is placed in the receptacle. The outer surface of the retention clip does not project outwardly from the rack when the retention clip is attached to the rack.

Abstract: An apparatus, a method and a device for calibrating the apparatus is disclosed. The apparatus comprises one or more light sources, at least one image acquisition device for acquiring images; and a device. The device comprises a processing unit, a memory coupled to the processing unit. The memory comprising a calibration module configured to obtain a value of current flowing through each of one or more light sources in real-time, compare the value of current flowing through each of the one or more light sources with a predefined threshold current value, and calibrate color gain value associated with at least one image acquisition device, if the determined value of current for each of the one or more light sources is above the predefined threshold current value.

Abstract: A method of detecting a level of a liquid in a well of a container. The method includes looking up an expected liquid level of the liquid in the well of a container; measuring and recording a measured liquid level of the liquid in the well; changing a level of the liquid in the well based upon an expected amount of the liquid to be added or removed; and calculating a next expected liquid level at least in part based on multi-point filtering. Apparatus for carrying out the method are provided, as are other aspects.

Abstract: Methods of troubleshooting non-event malfunctions. The methods include providing a database including pre-populated non-event issues and associated corrective actions, inputting search criteria regarding a particular non-event issue via entry of a search string at the user interface, parsing and normalizing the search string into a meta-data schema to produce a normalized search string, searching the database with the normalized search string to generate a listing of one or more particular corrective actions, and receiving the listing of one or more particular corrective actions that are associated with the normalized search string. Apparatus configured to carry out the methods are provided, as are other aspects.

Abstract: An embodiment is a sample analysis system for analyzing a sample that includes at least one test device for analyzing the sample. The system also includes a rack handler operable to move a sample from a first location to a second location along a travel path. The rack handler has a rotation assembly including a) an engagement element for engagement with the sample rack, and b) a motor coupled to the engagement element and is operable to cause rotation of the engagement element. The rotation assembly rotates the sample rack from a first orientation into a second orientation along the travel path when the engagement element engages the sample rack.

Abstract: Multi-use biosensors are disclosed that include enzymes that have been modified to reduce the solubility thereof; the multi-use biosensors are used to detect analytes in fluidic biological samples, and the biosensors also maintain their enzyme activity after many uses. Multi-sensor arrays are disclosed that include multiple biosensors. Also disclosed are methods of producing and using these devices.

Abstract: Systems and methods for use in an in vitro diagnostics setting incorporating existing or additional sensors in an automation system to assess the health and maintenance status of the automation system are disclosed. Such systems include any of a variety of sensors, such as Hall Effect sensors, temperature probes/thermocouples, ohm meters, volt meters, etc., which are in communication with a local or preferably remote monitoring station that can alert a user or maintenance personnel of needed service.

Abstract: Methods of scheduling maintenance on a plurality of automated testing apparatus and possibly also on ancillary test processing apparatus are provided. The methods include inputting identification data on the plurality of automated testing apparatus to be maintained, inputting maintenance requirement data for the maintenance of each of the apparatus, inputting demand constraint data, operating on the identification data, maintenance requirement data, and demand constraint data using an optimization program, such as mixed integer linear programming (MILP), subject to demand constraints and at least one objective, and outputting an optimized maintenance schedule for a planning period. Systems and apparatus configured to carry out the methods are also provided, as are other aspects.

Abstract: An assembly for use in a medical diagnostic device and system for analysis of one or more samples is disclosed. In one aspect of the invention, the assembly includes at least one extendable sample tray configured to hold the one or more samples. Additionally, the assembly includes at lease one holding unit coupled to the at least one extendable sample tray, wherein the holding unit is configured to hold a calibration marker. Furthermore, the extendable sample tray and the holding unit are arranged in the same plane and when the extendable sample tray is extended, the at least one holding unit is brought in a field of view of an image capturing unit.

Abstract: Devices, assemblies, and kits are disclosed for separating and/or metering a plasma sample from a patient's liquid test sample. Also disclosed are methods of producing and using same.