Described herein is a method for detecting the presence of circulating extracellular vesicles in a subject. The method comprises contacting a biological sample from the subject with an antibody mimetic that specifically binds to a cell surface marker on the vesicles, wherein the antibody mimetic is coupled to a detectable label; and detecting presence of extracellular vesicles in the sample by detecting the presence of the detectable label coupled to the antibody mimetic bound to the vesicles.

The present invention discloses a freeze-dried preparation of chemiluminescent immune microspheres, and a preparation method and an application thereof. The preparation is composed of one or more spherical solid particles having the same composition, which are uniform, smooth, and highly stable. In the preparation process, a magnetic particle coating raw material, an acridinium ester marking raw material and a reagent storage agent are freeze-dried into microspheres, so that the freeze-dried preparation can be stored and transported at normal temperature; the microspheres prepared in the present invention can be sub-packaged conveniently into individual packs, which are hygienic, simple and clear, and convenient to get and use, thereby the safety and convenience of use are improved. The preparation provided by the present invention and the test kit prepared according to the present invention can be used for immunoassays that are not for a disease diagnoses or treatment purpose.

A method of detecting a particular protein contained in an extracellular vesicle, the method including the steps of: (A) capturing the extracellular vesicle using a carrier capable of binding to an extracellular-vesicle-specific marker present on the surface of the extracellular vesicle; (B) carrying out membrane permeabilization treatment for the extracellular vesicle captured by the carrier, using a membrane permeabilization treatment agent; and (C) introducing a reagent capable of detecting the particular protein contained in the extracellular vesicle, into the membrane-permeabilized extracellular vesicle; wherein Step (B) is carried out such that the particular protein does not leak to the outside of the extracellular vesicle, and such that the reagent can be introduced into the extracellular vesicle.

A sample analysis substrate mountable and detachable to a sample analysis device and includes: a plate-shaped base substrate; and a chamber, the chamber being a space in which to cause a binding reaction, The sample analysis device includes: a motor to rotate the sample analysis substrate; a first magnet unit to attract the magnetic particles; a first actuator to move the first magnet unit to change relative positions of the first magnet unit and the sample analysis substrate; and a control circuit to control the motor, the drive circuit, and the first actuator. The first magnet unit shaped as a whole shape or a partial shape of a circle or a ring. During a B/F separation for separating reacted substance from unreacted substance, the first actuator moves the first magnet unit to a position where the magnetic particles in the chamber are attracted by the first magnet unit.

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.

A sample analyzer according to an embodiment includes a magnetic field applier configured to apply a magnetic field to a cartridge containing a sample and magnetic particles which bond an object to be detected in the sample; a measurer configured to measure the magnetic particles in the cartridge; and an analyzing processor configured to analyze and process a result of a measurement by the measurer. In addition, the magnetic field applier includes an electromagnet disposed on a first side of the cartridge; a magnetic member configured to be magnetized by the electromagnet; and a moving actuator configured to move the magnetic member.

Provided herein are encoded microcarriers for analyte detection in multiplex assays. The microcarriers are encoded with an analog code for identification and include a capture agent for analyte detection. Also provided are methods of making the encoded microcarriers disclosed herein. Further provided are methods and kits for conducting a multiplex assay using the microcarriers described herein.

Provided is a high-loading and alkali-resistant protein A magnetic bead. The magnetic bead can maintain chemical stability under pH 2-14 and has an immunoglobulin G (IgG) binding capacity greater than 50 mg/mL. Further provided is a method for purifying and/or detecting an immunoglobulin, comprising a step of contacting a sample containing the immunoglobulin with the high-loading and alkali-resistant protein A magnetic bead. The alkali-resistant protein A magnetic bead can realize rapid purification of immunoglobulin, saving about 80% of treatment time and reducing total purification costs by 50%. In addition, the alkali-resistant protein A magnetic bead has high alkali resistance. An alkaline method for in situ cleaning can be performed to regenerate the magnetic bead after use. The magnetic bead has rapid magnetic response and good dispersiveness, realizing rapid magnetic bead enrichment, cleaning, and elution. The magnetic bead facilitates automated, high-throughput, and large volume purification of a sample.

Disclosed is a chemiluminescence measurement apparatus that includes: a support member configured to support a cartridge for measuring a test substance contained in a specimen by chemiluminescence measurement; a motor configured to rotate the support member so as to rotate the cartridge such that a process required for the chemiluminescence measurement proceeds in the cartridge; and a light receiver configured to receive light generated by chemiluminescence in the cartridge that is supported by the support member rotated by the motor. The cartridge supported by the support member and a light receiving surface of the light receiver are disposed inside a dark space surrounded by a light-shielding portion, and the motor is disposed outside the dark space.

Disclosed is a detection apparatus that transfers magnetic particles through a plurality of chambers in a cartridge which includes the plurality of chambers and a channel connecting between the plurality of chambers, and that causes the magnetic particles to carry a complex of a test substance and a labelling substance, to detect the test substance on the basis of the labelling substance in the complex. The detection apparatus includes: a rotation mechanism configured to rotate the cartridge about a rotation shaft; a magnet configured to collect the magnetic particles in the chambers; a movement mechanism configured to move the magnet in a direction different from a circumferential direction of a circle in which the rotation shaft is centered; a detector configured to detect the test substance; and a controller programmed to control the rotation mechanism and the movement mechanism so as to transfer the magnetic particles from one of the chambers to another one of the chambers.