The invention provides systems and methods for rapid automated identification of microbes and antimicrobial susceptibility testing (AST) directly from a patient specimen, without specimen preparation. Specimens are loaded into an analytical cartridge for processing. Analytical cartridges are preloaded with species-specific labels that are used to identify and enumerate microbes in the specimen. Instruments, such as analyzers can be used to interact with analytical cartridges to carry out methods of the invention all within the cartridge.

Systems and methods for coupling photonic integrated subcircuits are described herein. The example system can include a first cartridge (4702) including a first photonic integrated subcircuit (4706) and a first alignment feature (4720, 4722). The system can include a second cartridge (4704) including a second photonic integrated subcircuit (4708) and a second alignment feature (4724, 4726), where the first alignment feature (4720, 4722) and the second alignment feature (4724, 4726) can be configured to enable alignment between the first photonic integrated subcircuit (4706) and the second photonic integrated subcircuit (4708). When the first photonic integrated subcircuit (4706) is aligned to the second photonic integrated subcircuit (4708), a first light path of the first photonic integrated subcircuit (4706) can be optically coupled to a second light path of the second photonic integrated subcircuit (4708).

Provided herein are devices, systems, and methods for particle sorting, including cell sorting, using microfluidics cartridges and microchips and the manufacture of the microfluidics cartridges and microchips by high-throughput approaches. Such methods, devices, and systems can be used to identify, sort, and collect a subset of particles or a single particle from a sample. The capability to manufacture such microfluidic tools in high volume may lower production costs and allow for the microfluidic tools to be used as consumables.

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.

A cassette holder holds a cassette for medical use. It includes a cassette receiving portion that includes a bottom surface to which a lower surface of the cassette is brought into contact when the cassette is set, and a plate-shaped portion that is provided in the cassette receiving portion, has a substantially plate-like shape, and extends substantially parallel to the bottom surface, and a protrusion inside of which is hollow, the protrusion being provided to the bottom surface to protrude downward. The bottom surface and the protrusion are provided with a plurality of through holes.

A digital microfluidics (DMF) device including an FET-biosensor (FETB) and method of field-effect sensing is closed. In some embodiments, the DMF device may include one or more FETBs integrated into the top substrate, the bottom substrate, or both the top and bottom substrates of the DMF device. In some embodiments, the DMF device may include one or more “drop-in” style FETBs in the top substrate, the bottom substrate, or both the top and bottom substrates of the DMF device. In some embodiments, the DMF device, FETB, and method of field-effect sensing provide active-matrix control integrated into an active-matrix DMF device. Further, a microfluidics system for and method of using the DMF device including at least one FETB is provided.

The present invention provides a diagnostic kit for detecting the presence or quantity of one or more test analytes within a test sample taken from a body surface of a mammal, the diagnostic kit comprising: a separate insert for a lateral flow device (200, 411) comprising a membrane (201) fixed to a rigid support (202) and, the separate insert being configured to obtain the test sample; a lateral-flow assay device configured (300, 400) to accept the separate insert (200, 411); a securing member (210) configured to releasably attach (211) the separate insert to a body surface of a mammal (213); wherein the securing member (210) comprise an expandable layer (212) configured to apply pressure to the separate insert (200, 411) thereby pressing the separate insert (200, 411) against the body surface of the mammal (213).

The present invention relates to a device (10) for use in fluid sample analysis. It is described to position (310) a top part (20) of the device (10) adjacent to a base part (30) of the device so as to define a fluidic receiving region in between, the top part being provided with a through opening fluidly connected to the fluidic receiving region, and the bottom part being provided with a radiation window adjacent to the fluidic receiving region. A fluidic sample is supplied (320) through the opening (24). The fluidic sample is moved laterally (330) in the fluid receiving region without the use of an intermediary membrane between the top part and the base part. A radiation is emitted (340) to the fluid receiving region. A radiation is detected (350) that is reflected by the device. A presence of the fluidic sample is determined (360) on the basis of a measured reflectance value based on the detected radiation.

The automatic analyzer includes a light source 4a to perform measurement, a spectrophotometer 4, a reagent disk 9 to store a reagent bottle 10 in which the reagent is stored, a carriage device to carry the reagent bottle 10 to the reagent disk 9, a reagent preparation unit to perform preparatory operations required before the regent bottle 10 is used, and a control unit 21 to schedule the preparatory operations by the reagent preparation unit and the carriage operation by the carriage device such that the reagent bottle 10 is carried to the reagent disk 9 immediately after an operation accompanied with analysis by the light source 4a and the spectrophotometer 4 is suspended or ends.

An apparatus (1) for detecting the presence and/or the quantity of a target component in a biological fluid in an integrated assay cartridge (52) of predetermined configuration, the assay cartridge comprising a capture component (22) at a predetermined location in the assay cartridge, the apparatus comprising: a detector (12)for detecting the amount of light scattered, transmitted or emitted by the sample to provide an indication of the presence and/or the quantity of the target component within the sample; three location positions (30), the three positions defining a location along the optical path of the detector on which to locate the cartridge of a predetermined size; wherein location positions are configured such that the capture component of the assay cartridge is located, in use, at the focal plane of the detector. Measures to ensure quality control may also be provided.