Abstract: In one embodiment, a biological sample analyzer has a housing having at least one outer wall that defines a cavity therein. A receptacle, which can support a consumable holder containing a biological sample, is disposed within the cavity. At least one heater applies heat to the consumable holder when the consumable holder is supported by the receptacle. At least one heater sensor detects a temperature of the receptacle over time. A controller directs the at least one heater to apply an elevated temperature to the consumable holder and reduces an amount of heat applied to the consumable holder before the consumable holder exceeds a target temperature that is less than the elevated temperature. By applying the elevated temperature, the consumable holder can be heated quicker than if it where heated at only the target temperature.

Abstract: The present invention relates to methods and compositions to remove or reduce biotin interference from certain assays.

Abstract: A system for coupling photometers to an incubation ring for use in in vitro diagnostics comprises one or more light sources, and an incubation ring assembly, and two photometers. An incubation ring assembly comprises an internal trough and an external trough. Each trough comprises (a) an internal wall comprising an internal aperture and (b) an external wall comprising an external aperture. A first photometer comprises: a first optics housing directing light from the light sources through the external aperture of the internal trough, and a first detector positioned to receive the light through the internal aperture of the internal trough. A second photometer comprises a second optics housing directing the light from the light sources through the internal aperture of the external trough, and a second detector positioned to receive the light through the external aperture of the external trough.

Abstract: Systems and methods for use in an in vitro diagnostics setting incorporating magnetic shielding to reduce exposure of any of samples, reactants, devices or people from exposure or prolonged exposure to magnetic or electromagnetic fields generated with the system. Some embodiments provide an automation system for use in an in vitro diagnostics setting comprising an automation track having a sidewall provided with magnetic shielding. In some embodiments, the magnetic shielding comprises an 80% nickel alloy.

Abstract: A method of training a neural network (Convolutional Neural Network-CNN) including reduced graphical annotation input is provided. The training method can be used to train a Testing CNN that can be used for determining Hemolysis (H), Icterus (I), and/or Lipemia (L), or Normal (N) of a serum or plasma portion of a test specimen. The training method includes capturing training images of multiple specimen containers including training specimens, generating region proposals of the serum or plasma portions of the training specimens; and selecting the best matches for the location, size and shape of the region proposals for the multiple training specimens. The obtained features (network and weights) from the training CNN can be used in a testing CNN. Quality check modules and testing apparatus adapted to carry out the training method, and characterization methods using abounding box regressor are described, as are other aspects.

Abstract: Disclosed is an antibody which binds to a symmetrically dimethylated arginine analyte that can be used to detect a symmetrically dimethylated arginine analyte in a sample, such as in a homogeneous enzyme immunoassay method.

Abstract: Described herein are innovations for classifying subtypes of DLBCL, as well as using the results of classification for diagnosis, prognosis, and therapy selection. In this way, the classifier can effectively classify subtypes of DLBCL and provide meaningful output for the benefit of medical practices and DLBCL patients. Also described are arrays and kits that can be used to measure expression of DLBCL signatures genes.

Abstract: Provided herein are color charts and water color pigment solutions useful, for example, in the calibration of reflectance-based diagnostic analyzers.

Abstract: Disclosed is a sensor assembly including a flow channel; two or more working electrodes located in the flow channel; and one or more reference electrodes located in the flow channel, wherein a total number of working electrodes is greater than a total number of reference electrodes. Volume in the flow channel may be minimized Liquid testing apparatus and methods of testing test liquids are provided, as are other aspects.

Abstract: A method for delivering a fluid sample through a channel of a diagnostic consumable is disclosed. The method includes receiving the diagnostic consumable in a reader comprising a delivery system, operatively connecting the delivery system to the channel, and applying pressure pulses to the channel at a predetermined frequency. A reader for reading a diagnostic consumable is also disclosed.

Abstract: Systems and methods include an optimization-based load planning module for laboratory analyzers of bio-fluid samples. The optimization-based load planning module is executable on a computer server and is configured to optimize assay (lab test) assignments across a large number of laboratory analyzers based on one or more of the following user selected and weighted objectives: reduced turn-around-time, load balancing, efficient reagent usage, lower quality assurance costs, and/or improved system robustness. The optimization-based load planning module outputs a load plan comprising computer executable instructions configured to cause a system controller of a laboratory analyzer system to schedule and direct each requested test to be performed at one or more selected laboratory analyzers of the laboratory analyzer system in accordance with the user selected and weighted objectives. Other aspects are also described.

Abstract: Methods are disclosed of designing antibodies for a sandwich assay for a small molecule having a molecular weight of about 500 to about 2,000. The method comprises preparing a first antibody that binds to the small molecule, and preparing a second antibody that binds to the small molecule at a portion of the small molecule other than a portion to which the first antibody binds. The second antibody is prepared from an immunogen that comprises a predetermined portion of the small molecule. The antibodies may be employed in sandwich assays for the small molecule.

Abstract: An analyzer system for in vitro diagnostics includes a sample handler module having a robot arm that delivers samples from drawers into carriers on a linear synchronous motor automation track. Samples are delivered via the automation track to individual track sections associated with individual analyzer modules. Analyzer modules aspirate sample portions directly from the sample carriers and perform analysis thereon.

Abstract: Diagnostic consumables for use in the analysis of fluid samples, such as whole blood, plasma or urine, are provided. The diagnostic consumables include a substrate having a sample preparation stage that includes an inlet port for receiving a fluid sample, an outlet port for dispensing a prepared fluid sample, and a channel extending from the inlet port to the outlet port. The channel includes an array of micro-projections extending into the channel to define a plurality of flow paths therebetween along at least a portion of a length of the channel between the inlet port and the outlet port. A material is disposed on the array of micro-projections for mixing with the fluid sample as the fluid sample is flowed through the channel to generate the prepared fluid sample. Methods of operating and manufacturing the diagnostic consumables are also provided.

Abstract: Methods of scheduling maintenance on a plurality of automated testing apparatus and possibly also on ancillary test processing apparatus. 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 provided, as are other aspects.

Abstract: Fluidic devices that include bubble traps are provided. A substrate for a fluidic device includes a first channel to carry a fluid; a chamber, coupled to the first channel, to receive the fluid from the first channel, the chamber having a top and a bottom; a second channel, coupled to the chamber, to receive the fluid from the chamber; and a plurality of barriers adjacent to the top of the chamber. The plurality of barriers inhibit bubbles in the fluid from entering the second channel. Methods for manufacturing and using fluidic devices that include bubble traps are also provided.

Abstract: Embodiments are directed to a transfer arm with a probe and a crash detection mechanism for use in a clinical analyzer in an in vitro diagnostics environment. The mechanism requires no user-intervention after a collision event, unless the automated inspection mechanism determines that damage to the probe requires probe replacement. Moreover, the mechanism is capable of protecting the probe, in some instances, from damage during a collision. The mechanism provides for automatic resetting after a collision, self-checking, and alignment correction. The mechanism includes a crash detection printed circuit assembly with a switch, and a spring-loaded contact sensor assembly configured to secure a probe within the transfer arm and allow for electrical connection between the switch and the probe during normal operation and electrical disconnection between the switch and the probe upon contact of the probe with an obstruction.

Abstract: A plasma separation system and process for providing filtered plasma from a blood sample is described. The system may include a blood separation well having a separation membrane for filtering the blood sample. The filtering process may be aided by the use of a negative or positive pressure source attached to the plasma separation system.

Abstract: An embodiment of the present disclosure is a sample vessel for a holding a sample for analysis by a sample analyzer. The sample vessel includes a body that includes a bottom, an open top spaced from the bottom along a first axis, a side wall that extends from the open top to the bottom, and an interior chamber for holding a sample and that extends from the open top toward the bottom along the first axis. The body includes an opaque portion, a first translucent portion, and a second translucent portion spaced from the first translucent portion a distance that extends along a second axis that is perpendicular to the first axis. The first and second translucent portions are each disposed along the bottom of the body.

Abstract: Devices, kits, and methods for (a) determining the presence and/or concentration of at least one analyte(s) of interest present in a patient's fluid sample and devices and methods of calibration related thereto, and (b) preventing, mitigating, and/or eliminating biofouling of an indwelling, wearable biosensor are disclosed and/or claimed herein.