An immunochromatography includes a concentration step of concentrating a solution capable of containing an antigen by ultrafiltration to obtain an antigen-concentrated solution; a spreading step of spreading particle composite bodies on an insoluble carrier having a reaction site at which a second binding substance capable of binding to an antigen in the antigen-concentrated solution has been immobilized, in a state where the particle composite bodies which are composite bodies of the antigen and a modified particle which is a particle modified with a first binding substance capable of binding to the antigen are formed; a capturing step of capturing the particle composite bodies at the reaction site of the insoluble carrier; and an amplification step of amplifying information of the particle composite bodies captured in the capturing step.

The invention provides a method for the immunological determination of an antibody against a drug antibody in a sample using a double antigen bridging immunoassay comprising a capture drug antibody and a tracer drug antibody, characterized in that the capture drug antibody is a mixture of said drug antibody conjugated to the solid phase at at least two different antibody sites and the tracer drug antibody is a mixture of said drug antibody conjugated to the detectable label at at least two different antibody sites.

An immunochromatography includes steps of mixing a specimen capable of containing an antigen and a modified particle, which is a particle modified with a substance having a specific affinity to the antigen, to obtain a mixture containing particle composite bodies; sedimenting the particle composite bodies in the mixture using a centrifuge; dissociating the sedimented particle composite bodies into the particles and the antigen by mixing the sedimented particle composite bodies with a dissociation solution, recovering an antigen-concentrated solution by sedimenting the dissociated particles using a centrifuge; neutralizing the antigen-concentrated solution using a neutralization solution; spreading particle composite bodies for labeling on an insoluble carrier having a reaction site, in a state where the particle composite bodies for labeling, which are composite bodies of the antigen in the neutralized antigen-concentrated solution and a modified particle for labeling, are formed; and capturing the particle composite bodies for labeling at the reaction site.

The present invention relates to systems and methods for detecting analyte molecules or particles in a fluid sample and in some cases, determining a measure of the concentration of the molecules or particles in the fluid sample. Methods of the present invention may comprise immobilizing a plurality of analyte molecules or particles with respect to a plurality of capture objects. At least a portion of the plurality of capture objects may be spatially separated into a plurality of locations. A measure of the concentration of analyte molecules in a fluid sample may be determined, at least in part, on the number of reaction vessels comprising an analyte molecule immobilized with respect to a capture object. In some cases, the assay may additionally comprise steps including binding ligands, precursor labeling agents, and/or enzymatic components.

The present disclosure relates to a device including a reagent portion in which a chemiluminescent indicator and a chemiluminescent substrate for the indicator are disposed, and a base on which the reagent portion is formed. The chemiluminescent indicator and the chemiluminescent substrate are disposed independently from each other in the reagent portion in such a manner that the chemiluminescent indicator and the chemiluminescent substrate can react with each other when a sample is supplied to the reagent portion. The present disclosure also relates to a remote diagnosis system including an imaging terminal for detecting a luminescent signal generated when a reagent is supplied to the device and an information processing unit for processing luminescent signal data obtained by the imaging terminal. The imaging terminal and the information processing unit can bi-directionally communicate with each other via a network.

The present disclosure provides methods and kits for detecting Group A Streptococcus in biological samples. More particularly, the present disclosure provides methods for enhancing the specificity and sensitivity of Group A Streptococcus immunoassays by including N-propionyl-D-glucosamine, 2-N-butanoyl-D-glucosamide, Bis-(2-(D-2-deoxy-glucosaminyl))-PEG3-amide, m-PEG4-glucosamine, m-PEG6-glucosamine, or m-PEG10-glucosamine. The methods and kits disclosed herein are thus useful for reliable and early diagnosis of streptococcal infections in a subject.

The present invention provides systems, devices, and methods for point-of-care and/or distributed testing services. The methods and devices of the invention are directed toward automatic detection of analytes in a bodily fluid. The components of the device can be modified to allow for more flexible and robust use with the disclosed methods for a variety of medical, laboratory, and other applications. The systems, devices, and methods of the present invention can allow for effective use of samples by improved sample preparation and analysis.

The present disclosure provides a compound having Formula (I): or a pharmaceutically acceptable salt of hydrate thereof, wherein R.sup.1, A, m, and n are as described herein, for use in conducting immunodiagnostic assays for accurately measuring concentrations of circulating vitamin D, as well as for thyroxine and related analytes, estrogen and related analytes, and testosterone and related analytes.

##STR00001##

A problem of the present invention is to provide an immunochromatographic test strip avoiding agglutination of colloidal gold while red blood cells in whole blood are agglutinated and then separated and removed in the case of using polybrene as a hemagglutinating agent and the colloidal gold conjugates as a detection reagent, and to provide immunochromatography using the test strip. To solve the problem, the present inventors reviewed the composition of the existing reagent itself from a completely different viewpoint rather than the selection of type or amount of polyanions, and as a result of extensive study on each element, the inventors surprisingly found that agglutination of colloidal gold may be suppressed by using a particular additive without neutralization by polyanions.

There is described a process for improving precision in an analytical test for a target analyte in a sample. The process includes prior to analyzing the sample for a target analyte via a biosensor, introducing to an analytical zone defined by the biosensor fluid comprising an effective amount of the target analyte.