A method of fabricating a substrate for analysis fixes antibodies that specifically react with specific antigens included in detection target substances to the substrate for analysis. The method subjects the substrate for analysis to immersion treatment with a predetermined treatment solution so as to form antibody aggregations in which the antibodies are aggregated at boundary regions between recesses and convex portions on the substrate for analysis. The method causes the antigens and the antibodies to react with each other so as to capture the detection target substances on the substrate for analysis by the antibody aggregations.

Disclosed are a one-pot biosensor and an immunoassay method using the same. The one-pot biosensor includes a photocatalyst substrate deposited with metal nanoparticles; and a reaction pad which is disposed on an upper surface of the photocatalyst substrate and includes a first binding material-fluorescent material complex specifically binding to a molecule to be detected, and the immunoassay method using the same. The one-pot biosensor may detect a target by once solution injection and has a size enough to be portable. Accordingly, since the one-pot biosensor can detect the target by only once solution injection without a washing step, because of a sensor platform capable of being easily used by an individual other than a diagnostic expert, it is predicted to be positioned as a means capable of confirming the health condition of the individual without seeing the doctor, such as a pregnancy diagnostic kit which has been currently commercialized.

The present invention provides assays and assay systems for use in spatially encoded biological assays. The invention provides an assay system comprising an assay capable of high levels of multiplexing where reagents are provided to a biological sample in defined spatial patterns; instrumentation capable of controlled delivery of reagents according to the spatial patterns; and a decoding scheme providing a readout that is digital in nature.

The disclosed technology includes a planar device for performing multiple biochemical assays at the same time, or nearly the same time. Each assay may include a biosample including a biochemical, enzyme, DNA, and/or any other biochemical or biological sample. Each assay may include one or more tags including dyes and/or other chemicals/reagents whose optical characteristics change based on chemical characteristics of the biological sample being tested. Each assay may be optically pumped to cause one or more of luminescence, phosphorescence, or fluorescence of the assay that may be detected by one or more optical detectors. For example, an assay may include two tags and a biosample. Each tag may be pumped by different wavelengths of light and may produce different wavelengths of light that is filtered and detected by one or more detectors. The pump wavelengths may be different from one another and different from the produced wavelengths.

Devices, methods, and kits are provided for allergy testing based on basophil activation in a blood sample. Susceptibility of an individual to an allergic reaction to an allergen is detected by collecting a blood sample from the individual and assaying for activation of basophils in response to stimulation with an allergen. In particular, a microfluidic device is provided for automating the assay for detecting basophil activation as an indication of the susceptibility of an individual to an allergic reaction as well as kits containing such a device and diagnostic methods for using such a device for allergy testing. Additionally, such a microfluidic device can be adapted for multiplexed detection of allergic responses to multiple allergens by performing assays in parallel to detect the basophil responses to each allergen.

An imaging system and method for detecting a target in a sample. The imaging system includes a lens-free holographic microscope having a light source in a first plane spaced above an image sensor. The image sensor extends in a second plane. The system also includes a microfluidic chip positioned between the light source and the image sensor. The microfluidic chip extends in a third plane, which is parallel to the second plane. There is at least one chamber in the microfluidic chip configured to receive a sample solution with a target. The system also has a plurality of functionalized beads positioned within the at least one chamber in the microfluidic chip. Any two of the plurality of functionalized beads have an affinity for binding together when exposed to the target in the sample solution.

A microfluidic device including a microwell array having microwells, and a cover member facing the microwell array with a gap between the cover member and the microwell array, and having a flow path formed in the gap. The cover member has a surface facing the microwell array, and the surface has an arithmetic average roughness Ra of 70 nm or less.

Some embodiments of the present disclosure are directed to systems and methods for separating, directing, and/or extracting a target molecule from a mix of molecules and may comprise a plurality of non-magnetic beads suspended in a ferro fluid, where the non-magnetic beads may be functionalized with at least one predetermined first molecule configured to bind with a target particle. A microfluidic device may be included which may comprise at least one microfluidic channel, the device configured to dynamically and/or statically receive an amount of the mix. Magnetic field means may be included and may be configured to apply a magnetic field to at least a portion of the at least one channel to exert an indirect force on the non-magnetic heads in the ferro fluid mix, and separate the non-magnetic beads from the ferrofluid. The beads may then be directed to at least one receptor region. At least one outlet may be provided which is arranged to be in communication with the at least one microfluidic channel, the at least one outlet may be configured to receive and extract the separated non-magnetic beads from the ferrofluid.

A system comprised of an apparatus and a test device is described. The test device and the apparatus are designed to interact to determine the presence or absence of an analyte of interest in a sample placed on the test device.

The present invention provides devices and systems for use at the point of care. The methods devices of the invention are directed toward automatic detection of analytes in a bodily fluid. The components of the device are modular to allow for flexibility and robustness of use with the disclosed methods for a variety of medical applications.