The accuracy of immunoassay using a latex reagent is improved in a high CRP concentration range. Provided are C-reactive proteins generated by genetic recombination, 55% or more of the C-reactive proteins having a pyroglutamylated N-terminal.

The accuracy of immunoassay using a latex reagent is improved in a high CRP concentration range. Provided are C-reactive proteins generated by genetic recombination, 55% or more of the C-reactive proteins having a pyroglutamylated N-terminal.

The present invention provides a method for capturing specific cells (e.g. many types of cancer cells, including cancer cells not expressing EpCAM), and a method for analysis of specific cells involving the method. Included is a method for capturing specific cells present in blood or biological fluid, the method including: agglutinating blood cells in sampled blood or biological fluid; centrifuging the resulting blood or biological fluid; and then capturing specific cells therefrom onto a hydrophilic polymer layer.

The present invention provides a method for capturing specific cells (e.g. many types of cancer cells, including cancer cells not expressing EpCAM), and a method for analysis of specific cells involving the method. Included is a method for capturing specific cells present in blood or biological fluid, the method including: agglutinating blood cells in sampled blood or biological fluid; centrifuging the resulting blood or biological fluid; and then capturing specific cells therefrom onto a hydrophilic polymer layer.

A reagent for detection of urine monophenolic metabolites and a method for preparing the reagent are disclosed, in which the monophenolic metabolites, for example, tyrosine, p-hydroxyphenyl alanine, tryptophan and 5-hydroxyindoleacetic acid can serve as tumor markers. The reagent for detection of urine monophenolic metabolites is an aqueous solution containing nitric acid, sulfuric acid, mercuric sulfate, mercurous nitrate, nickel nitrate, phosphomolybdic acid and cobalt sulfate. The preparation method includes preparation of solutions A, B, C, D and E, and mixing. The subject matter allows easy availability of raw materials, low cost, a simple preparation process, obtainment of reagents with stable performance which offer the advantages including high versatility, high sensitivity and good specificity when used in cancer detection, a simple detection process, a short detection cycle and easy determination, and is particularly suitable for large population screening, assistance in clinical cancer diagnosis and dynamic follow-up.

Assays and methods for verifying the validity of a urine sample submitted for Drugs of Abuse (DOA) testing. Embodiments include a SUD Diagnostic Panel that includes six assays: specific gravity index assay, long-duration counterfeit urine assay, short-duration counterfeit urine assay, oxidant history assay, pH assay, and creatinine assay. The SUD Diagnostic Panel detects twelve principle classes of adulteration. Detection of adulteration of one or more urine samples from a patient indicates an attempt to subvert test results and provides an objective indication in one instance and an object diagnosis in another instance of SUD.

Assays and methods for verifying the validity of a urine sample submitted for Drugs of Abuse (DOA) testing. Embodiments include a SUD Diagnostic Panel that includes six assays: specific gravity index assay, long-duration counterfeit urine assay, short-duration counterfeit urine assay, oxidant history assay, pH assay, and creatinine assay. The SUD Diagnostic Panel detects twelve principle classes of adulteration. Detection of adulteration of one or more urine samples from a patient indicates an attempt to subvert test results and provides an objective indication in one instance and an object diagnosis in another instance of SUD.

Methods and kits for detecting antibodies (e.g., anti-drug antibodies). Such methods and kits permit the detection of, for example, anti-drug antibodies in human body fluids, such as blood, plasma and serum.

Methods and kits for detecting antibodies (e.g., anti-drug antibodies). Such methods and kits permit the detection of, for example, anti-drug antibodies in human body fluids, such as blood, plasma and serum.

An atomic level deposition for mass functionalization of a cavity filled with a pathogen sensitive antibody reagent to functionalize each biosensor using atomic level vapor phase deposition enables high volume production of this sensor technology. A biosensor has a first substrate and a second substrate with a cavity formed in the first substrate to form a membrane. Holes are formed through the second substrate. An aluminum oxide layer is formed over the cavity and into the holes to form cores. The cavity is filled with a pathogen sensitive antibody reagent. A biofluid sample with the pathogen is deposited over the membrane. The biofluid is drawn through the cores to mix with the antibody reagent. The antibodies combine with the pathogen to change the impedance along the current path. The presence of the pathogen changes the ionic current flow through the biosensor for a positive detection of the pathogen.