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.

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.

Disclosed herein are formulations, substrates, and arrays. Also disclosed herein are methods for manufacturing and methods of assuring a uniformly high quality of a microarray of features that are attached to a surface of the microarray at positionally-defined locations.

The present disclosure is directed to microneedle patches for direct sampling and ultrasensitive detection of protein biomarkers in dermal interstitial fluids. The microneedle patches are comprised of polymers with high protein absorption capability (e.g. polystyrene) and are modified with capture biorecognition elements that are specific to target analytes in the interstitial fluid (ISF). Systems and methods are further provided for detection of a target ISF analyte obtained by in vivo sampling of the ISF using a microneedle patch.

Described herein is an assay device, comprising a substrate comprising microfluidic geometry, and a reagent layer disposed adjacent to the substrate.

The present invention relates to a cancer diagnostic apparatus for checking a cancer incidence by allowing an antibody (captured antibody), which reacts with an rpS3 (ribosomal protein S3; antigen) capable of checking a phenomenon of a cancer, to react with the rpS3, and performing concentration measurement after extracting an emission signal of the reacted antigen (rpS3), and a cancer diagnostic system using the cancer diagnostic apparatus. The cancer diagnostic system includes: the cancer diagnostic apparatus for irradiating an ultraviolet ray (UV) from a bottom of a bio-chip provided with an antibody reacting with an antigen (ribosomal protein S3; rpS3), making an image from a visible ray obtained from the ultraviolet ray, which is converted by the antigen and the antibody bound to each other while passing through the bio-chip, and extracting only a specific frequency color from the visible ray to generate cancer diagnosis information; and a user terminal.

This system takes in raw cellular material collected using a provided swab, blood collection device, urine collection device, or other sample collection device and transforms that biological material into a digital result, identifying the presence, absence and/or quantity of nucleic acids, proteins, and/or other molecules of interest.

A rapid detection method of a target biomolecule comprising an antigenic moiety is provided. The method includes providing a source biological sample comprising the target biomolecule; contacting the source biological sample to an ion-exchange medium; eluting the captured-target biomolecule from the ion-exchange medium as an eluate, and loading the eluate to a rapid diagnostic testing device comprising an antibody. The eluate comprises a concentrated form of the biomolecule in a solution having a salt concentration greater than 150 mM. A concentration of the target biomolecule in the eluate is in a range from about 2× to 25× compared to a concentration of the biomolecule in the source biological sample. The target biomolecule binds to the antibody under the salt concentration of greater than 150 mM. A device for rapid detection of target biomolecule is also provided.

A method of quantitating free (unbound) human C5a complement protein (C5a) from a sample comprising: binding biotinylated anti-C5a capture antibody to strepavidin-coated particles; capturing the free (unbound) C5 in the sample; detecting the captured free C5a; and quantitating the captured free C5 using laser-induced fluorescence detection; wherein the method is performed in a Gyros Bioaffy 200 CD in a Gyrolab xPlore or a Gyrolab XP instrument; wherein human C5 is first removed from the sample.