A particle-based assay system is disclosed that uses hydrogel microparticles that capture analytes of interest from a sample which are subsequently bound with catalytic reporter complexes. Catalytic reporter complexes bound to the hydrogel microparticles generate signals that are accumulated in the vicinity of the hydrogel microparticle at high concentration (or on or within the hydrogel microparticles). In some circumstances, the reporter complex-bound hydrogel microparticles are encapsulated in an emulsion. Preferably, the emulsion is substantially uniform and contains one hydrogel microparticle per droplet. The accumulated signal generated by the catalytic reporter complexes is contained inside the emulsion, and/or optionally immobilized onto or inside the hydrogel microparticle. Signals are read and analyzed using optical instruments such as flow cytometers. Breaking the emulsion prior to signal analysis is optional. In some embodiments, a sample is introduced to hydrogel microparticles in a dried state to concentrate analytes of interest.

An object of the present invention is to provide a method for measuring an object to be measured in a specimen by an enzymatic method, the measurement method being able to suppress the positive influence of peroxide derived from the specimen. More specifically, an object of the present invention is to provide a measurement method and a measurement reagent that can suppress elevation in value regardless of whether or not the specimen is a catalase-free specimen. Provided is a measurement method that can accurately quantify hydrogen peroxide derived from an object to be measured, without influence derived from a specimen, by contacting the specimen with an enzyme in the presence of at least one compound selected from the group consisting of a compound represented by the following general formula (I), a benzimidazole derivative having an electron-donating substituent at position 2, and histidine, wherein R1 and R2 are the same or different and each represent hydrogen, a linear or branched alkyl group having 1 to 6 carbon atoms and optionally having a substituent, an aryl group optionally having a substituent, or an alkyloxy group having 1 to 6 carbon atoms.

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A method for testing a sample for the presence of one or more targets comprises multiplexed catalyzed reporter deposition (CARD) is provided.

A system for virus detection in a sample from a subject includes a microchip comprising at least one channel containing the sample from the subject and a mobile device. The sample is processed with nanoparticles and a catalyzer that are configured to generate gas bubbles in the presence of a target virus on a surface of the microchip. The mobile device includes a camera configured to acquire an image of the microchip containing the sample from the subject, a neural network configured to receive the acquired image and to generate a probability regarding the presence of the target virus in the sample from the subject based on the acquired image, and a display coupled to the neural network and configured to display the probability regarding presence of the target virus in the sample from the subject.

Disclosed herein are immunoassays for detecting an anti-thyroid peroxidase antibody in a biological sample from a subject and/or diagnosing a thyroid disease in a subject. The disclosed immunoassays employ a recombinant cynomolgus monkey thyroid peroxidase (rTPO) and assess the level of anti-thyroid peroxidase antibody-induced formation or disruption of complexes comprising a solid support and the rTPO.

Reagents, assays, methods, kits, devices, and systems for rapid measurement of cholesterol and cholesterol sub-fractions from a blood sample are provided. Total cholesterol, low density lipoprotein cholesterol, and high density lipoprotein cholesterol can be measured in a single assay using kinetic measurements, under conditions in which cholesterol sub-species are converted to a detectable product at distinct rates. The detectable product is measured at different times after assay initiation. A lipase, cholesterol esterase, cholesterol oxidase and a peroxidase may be used together to produce colored product in amounts directly proportional to the quantity of cholesterol converted. Methods for calculating very-low density lipoprotein cholesterol levels by further including triglyceride measurements are disclosed. Assays may be performed in a single reaction mixture, allowing more accurate and precise cholesterol determinations, including ratios of cholesterol sub-fractions to total cholesterol, at less expense, than would be expected by performing several different assays in different reaction mixtures.

Disclosed herein are immunoassays for detecting an anti-thyroid peroxidase antibody in a biological sample from a subject and/or diagnosing a thyroid disease in a subject. The disclosed immunoassays employ a recombinant cynomolgus monkey thyroid peroxidase (rTPO) and assess the level of anti-thyroid peroxidase antibody-induced formation or disruption of complexes comprising a solid support and the rTPO.

Some embodiments described herein relate to systems and methods operable to combine immunoassay and Total Protein techniques in a single sample run. Some embodiments described herein allow for multiple sequential immunoassays to be performed in the same microfluidic device. Some embodiments described herein relate to stripping reagents operable to remove primary antibodies associated with immunoassays. Such stripping reagents can allow for additional immunoassays and/or Total Protein assays to be performed on the same sample.

Hepatitis E virus (HEV) is annually responsible for 20 million infections with 3.4 million symptomatic cases and 70,000 deaths mainly occurring in less developed regions of the world. HEV is a non-enveloped virus containing a linear, single-stranded, positive-sense RNA genome that contains three open reading frames (ORFs), namely, ORF1, ORF2 and ORF3. ORF2 encodes the ORF2 viral capsid protein, which is involved in particle assembly, binding to host cells and eliciting neutralizing antibodies. Recently, 3 different forms of the ORF2 capsid protein were identified: infectious/intracellular ORF2 (ORF2i), glycosylated ORF2 (ORF2g), and cleaved ORF2 (ORF2c). The ORF2i protein, for which the precise sequence has been identified, is the form that is associated with infectious particles and thus antibodies having specificity for the ORF2i protein would be suitable for the diagnosis of HEV. The present fulfills this need by providing an antibody which binds to the ORF2i protein of hepatitis E virus and wherein said antibody does not bind to the ORF2g protein nor to the ORF2c of hepatitis E virus, and wherein the epitope of said antibody comprises at least one amino acid residue from amino acid residues 542 to 555 of SEQ ID NO: 1.

Some embodiments described herein relate to systems and methods operable to combine immunoassay and Total Protein techniques in a single sample run. Some embodiments described herein allow for multiple sequential immunoassays to be performed in the same microfluidic device. Some embodiments described herein relate to stripping reagents operable to remove primary antibodies associated with immunoassays. Such stripping reagents can allow for additional immunoassays and/or Total Protein assays to be performed on the same sample.