Point-of-care biomarker assay apparatus arranged for measuring a presence or concentration of a biomarker in a sample, said biomarker assay apparatus comprising cartridge receiving means arranged for receiving at least one cartridge having multiple chambers designed for receiving a plurality of liquid media comprising said sample, labelled binding reagent, magnetic beads reagent and wash buffer, a sample distribution unit arranged for processing pipetting steps with said chambers, thereby providing a liquid reactant mixture in one or more of said chambers, a magnetic coil assembly arranged for applying a magnetic field to said liquid reactant mixture for separating biomarkers bound to said magnetic beads and said labelled binding reagent, from said reactant mixture, a photo detector or assembly arranged for measuring said presence or concentration of said labelled binding reagent, a control unit arranged for controlling said processing pipetting steps with said chambers, and for controlling said sample distribution unit along said chambers according to a test protocol, wherein said test protocol comprises an order of subsequent processing steps performed in said plurality of chambers to be processed by said sample distribution unit, said processing steps comprising one or more processing pipetting steps by the sample distribution unit and one or more processing incubation steps of the reaction mixture within any of the chambers wherein the control unit being programmed for performing multiple, distinct test protocols.

The invention provides a version of fluorescent in situ hybridization (FISH) in which all the steps are performed at physiological temperatures, i.e., body temperature, to detect and identify pathogenic bacteria in clinical samples. Methods of the invention use species-specific fluorescent probes to label clinically important infectious bacteria. A sample such as a urine sample is loaded into a cartridge, fluorescently labeled, and imaged with a microscope. Labelled bacteria are pulled down onto an imaging surface and a dye cushion is used to keep unbound probes off of the imaging surface. A microscopic image of the surface shows whether and in what quantities the infectious bacteria are present in the clinical sample.

A diagnostic system performs a first nucleic acid amplification reaction and a second, different nucleic acid amplification reaction. The diagnostic system includes a compartment configured to store at least a first bulk reagent container comprising a first bulk reagent for performing a sample preparation process, and a second bulk reagent container comprising a second bulk reagent for performing the first reaction. The system including a compartment configured to store at least one unit-dose pack comprising a plurality of unit-dose reagents for performing the second reaction. The diagnostic system is configured to perform the sample preparation process using the first bulk reagent on each of a plurality of samples provided to the diagnostic system. The system is configured to perform the first reaction using the second bulk reagent on a first sample subset, and perform the second reaction using the plurality of first unit-dose reagents on a second sample subset.

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.

An analysis tool for use mounted to an analysis device that automatically analyzes a specified component contained in a sample. The analysis tool includes a light measurement well to hold a measurement solution as a measurement subject, and to measure the measurement solution. The light measurement well includes an opening to dispense the measurement solution through, a measurement solution holder to hold the measurement solution dispensed through the opening, and an emission section that emits measurement light caused to be emitted from the measurement solution held in the measurement solution holder in a light receiving direction of the analysis device. The measurement light is fluorescent light or chemiluminescent light. The measurement solution holder has a flattened profile that is flattened in the light receiving direction.

Aspects of the present disclosure include sample analysis methods and systems. According to certain embodiments, provided are methods of analyzing samples in an automated sample analysis system. The methods include introducing samples and sample preparation cartridges into the system, isolating and purifying an analyte (e.g., nucleic acids and/or proteins) present in the samples at a sample preparation station, and performing analyte detection assays in assay mixtures that include the purified analyte. Also provided are automated sample analysis systems that find use, e.g., in performing the methods of the present disclosure. In certain aspects, the methods and systems provide for continuous operator access during replenishment or removal of one or any combination of samples, bulk fluids, reagents, commodities, waste, and/or the like.

Described is a lateral flow high throughput assay device analyzer for preparing and analyzing a plurality of lateral flow assay samples. The analyzer comprises a cartridge stage for supporting an assay cartridge, an elevation adjustment mechanism, and a translation adjustment mechanism for aligning the cartridge stage and assay cartridge relative to a vertical support structure, fluid metering device, and detection device for high throughput lateral flow assay analysis.

In one embodiment, a method is provided comprising analyte testing on one or more types of samples.

A cassette may include, in an example, a substrate, a die coupled to the substrate, and a reservoir defined in the substrate exposing a proximal side of the die to an external atmosphere wherein at least a portion of the die is proud relative to at least one surface of the substrate.

A specimen treating and measuring system according to the present invention comprises: a treatment part having a plurality of lanes for carrying out parallel processing of a plurality of specimens, and mounting cartridges in each of the plurality of lanes; a cartridge storing unit storing a plurality of types of cartridge to be used for different processes corresponding to the plurality of specimens; a sample storing unit storing and conveying sample tubes containing the plurality of specimens; a pickup unit transferring each of the plurality of types of cartridge to each lane, and transferring each of the plurality of specimens from the sample tubes to each of the plurality of lanes; and a control unit controlling the transfer of the plurality of types of cartridge and the transfer of the plurality of specimens, performed by the pickup unit.