A system for detecting analytes in a test sample, and a method for processing the same, is provided. The system includes a cartridge reader unit that has a control unit and a pneumatic system, and a cartridge assembly that prepares the samples with mixing material(s) through communication channels. The assembly has a memory chip with parameters for preparing the sample and at least one sensor (GMR sensor) for detecting analytes in the sample. The assembly is pneumatically and electronically mated with the reader unit via a pneumatic interface and an electronic interface such that the parameters may be implemented via the control unit. The pneumatic system is contained within the unit and has pump(s) and valve(s) for selectively applying fluid pressure to the pneumatic interface of the assembly, and thus through the communication channels, to move the sample and mixing material(s) through and to sensor. The control unit activates the pneumatic system to prepare the sample and provide it to the sensor for detecting analytes, and also processes measurements from the sensor to generate test results.

Flow cells and corresponding methods are provided. The flow cells may include a support frame with top and back sides, and at least one cavity extending from the top side. The flow cells may include at least one light detection device with an active area disposed within the at least one cavity. The flow cells may include a support material disposed within the at least one cavity between the support frame and the periphery of the at least one light detection device coupling them together. The flow cells may include a lid extending over the at least one light detection device and coupled to the support frame about the periphery of the at least one light detection device. The lid and at least a top surface of the at least one light detection device form a flow channel therebetween.

Methods of detecting the presence of an analyte in a query sample include providing a sensor that includes biomolecules disposed on a polymer-coated surface of a giant magnetoresistance (GMR) sensor. Modes of operation remove or add magnetic beads from the vicinity of the sensor surface by interactions with the biomolecules. The methods feature detecting the presence of the analyte in the query sample by measuring resistance change of the GMR sensor based on determining resistance before and after passing magnetic particles over the sensor.

The present invention is related to, among other things, the devices and methods that improve the accuracy and reliability of an assay, even when the assay device and/or the operation of the assay device has certain errors, and in some embodiments, the errors are random. One aspect of the present invention is to overcome the random errors or imperfections of an assay device or the operation of the assay device by measuring, in addition to measuring the analyte in a sample to generate an analyte test result, the trustworthiness of the analyte test result. The analyte test result will be reported, only when the trustworthiness meets a predetermined threshold, otherwise the analyte test result will be discarded. Various of parameter variation have been used for test trustworthy determination.

A handling system for high throughput processing of a large volume of biological samples is provided herein. Such systems can include an array support assembly that supports multiple diagnostic assay modules in an array having at least two dimensions, a loader that loads multiple diagnostic assay cartridges within the multiple diagnostic assay modules. The array support assembly can be movable relative the loader to facilitate loading and unloading so as to provide more efficient processing.

This invention relates to a cartridge assembly tray for conducting automated biochemical tests, such as immunoassay tests. The tray comprises a base member, a hinged frame and a locking mechanism. The base member includes a plurality of slots within the base member. Each of the plurality of slots is to receive a test cartridge. The hinged frame is coupled to the base member. The hinged frame is capable to rotate to an opened position or a closed position. The hinged frame includes a horizontal push bar configured to apply a downward force to test cartridges received in the plurality of slots when the hinged frame is in the closed position. The locking mechanism is to lock the hinged frame in the closed position when the hinged frame rotates to the closed position.

The present invention relates to a device which is easy to use and in which real-time reaction product detection through nucleic acid extraction from a biospecimen, a PCR reaction, and scanning of excitation light of various wavelengths and fluorescence corresponding thereto can be automated, and thus various tests can be carried out in a single operation, and in particular, accurate results can be obtained in a short amount of time.

Flow cells and corresponding methods are provided. The flow cells may include a support frame with top and back sides, and at least one cavity extending from the top side. The flow cells may include at least one light detection device with an active area disposed within the at least one cavity. The flow cells may include a support material disposed within the at least one cavity between the support frame and the periphery of the at least one light detection device coupling them together. The flow cells may include a lid extending over the at least one light detection device and coupled to the support frame about the periphery of the at least one light detection device. The lid and at least a top surface of the at least one light detection device form a flow channel therebetween.

A joint point-of-care testing (POCT) analyzer, and a system comprising an analyzer and a cartridge, for measuring one or more analyte quantities per unit volume of blood and one or more formed element quantities per unit volume of blood, is described. Examples of formed elements of blood are red blood cells and white blood cells, and cell counts are determined by imaging using a two-dimensional multi-channel detector. Examples of analytes are hemoglobin and bilirubin, and hemoglobin and bilirubin concentrations are determined by spectroscopy using a one-dimensional multi-channel detector. Other examples of analytes are electrolytes, and electrolyte concentrations may be determined using biosensors incorporated in the cartridges.

A system, including method and apparatus, for generating droplets suitable for droplet-based assays. The disclosed systems may include either one-piece or multi-piece droplet generation components configured to form sample-containing droplets by merging aqueous, sample-containing fluid with a background emulsion fluid such as oil, to form an emulsion of sample-containing droplets suspended in the background fluid. In some cases, the disclosed systems may include channels or other suitable mechanisms configured to transport the sample-containing droplets to an outlet region, so that subsequent assay steps may be performed.