Abstract: An immunoassay utilizing a monoclonal antibody which specifically reacts with both of P1 protein and P30 protein of Mycoplasma pneumoniae, which monoclonal antibody has a higher affinity with P1 protein and P30 protein of Mycoplasma pneumoniae than the known monoclonal antibodies, is disclosed. The immunoassay utilizes an antigen-antibody reaction between a monoclonal antibody which specifically reacts with P1 protein and P30 protein of Mycoplasma pneumoniae and which specifically reacts with a peptide containing an amino acid sequence composed of PPQPG or antigen-binding fragment thereof, and P1 protein and P30 protein derived from Mycoplasma pneumoniae.

Abstract: The present invention intends to provide an immunochromatographic test piece that makes it possible to achieve both highly sensitive detection of a substance to be detected and a simple test piece structure, which are usually difficult to be made compatible with each other.

Abstract: A technology to determine an appropriate detection region in automatic determination of an immunochromatographic assay and an immunochromatographic assay interpretation device wherein a liquid sample including a detectable substance spreads into a region for detection via a test strip, and a negative or positive determination is made from the coloration state of the detection region, wherein a measuring unit acquires coloration index data for a range including at least a portion of a sample developing detection region for indicating that a sample has reached the detection region downstream from the detection region in the test strip, and a processing unit specifies the detection region from the coloration index data, the detection region in a predetermined inter-region distance upstream from the detection region of the coloration index data, and interprets negative or positive based on the coloration state of the detection region.

Abstract: A diagnostic testing device is a testing-device for immunochromatography wherein a liquid sample contains an analyte developed in a detection area via a labeling-substance-containing area of a test strip, and a negative or positive interpretation is made from the coloration exhibited by the detection area. The device includes a measuring part for obtaining data on a coloration index associated with coloration state for at least part of the detection area, and a processing part that interprets based on the coloration index data. The processing part delivers a negative interpretation if the coloration state of the analyte detection area is in a negative state in at least one image out of a maximum of N (wherein N is greater than 1) obtained images, and delivers a positive assessment if the coloration state of the analyte detection area is in a positive state in all N images.

Abstract: An object of the present invention is to improve visibility by reducing background noise in order to accurately detect the signal from a target substance in an immunochromatographic device. The immunochromatographic device comprises a membrane having a detection region, to which an antibody or antigen serving as a capturing substance capable of capturing a target substance is immobilized, for detecting the target substance by using an antigen or antibody labeled with a labeling carrier that is a colored particle to form a complex of the capturing substance-target substance-labeled antigen or antibody in the capturing substance-immobilized detection region on the device, based on color of the labeling carrier, wherein a colorant having a color complementary to the color of the labeling carrier is allowed to be contained in a dry state in a constituent member of the device such that the colorant is developed together with a specimen when the specimen is developed on the device.

Abstract: Disclosed is an immunochromatographic test strip by which the influences by the interfering substances in the immunochromatography method, contained in test samples, are reduced, so that it enables to accurately and specifically measure a test substance in a test sample irrespective of the amount of the test sample supplied to the assay, and to provide an immunochromatography method using the immunochromatographic test strip. The immunochromatographic test strip includes, in the order from upstream, a sample pad, a labeled substance region, a detection region and an absorption band, wherein a polymer(s) in which hydrophobic cyclic monomer(s) having an ionic functional group(s) is/are polymerized is impregnated at a region(s) upstream of the labeled substance region.

Abstract: The present invention intends to provide an immunochromatographic test piece that makes it possible to achieve both highly sensitive detection of a substance to be detected and a simple test piece structure, which are usually difficult to be made compatible with each other.

Abstract: The present invention intends to provide an immunochromatographic test piece that makes it possible to achieve both highly sensitive detection of a substance to be detected and a simple test piece structure, which are usually difficult to be made compatible with each other.

Abstract: Disclosed is an immunochromatographic test strip by which the influences by the interfering substances in the immunochromatography method, contained in test samples, are reduced, so that it enables to accurately and specifically measure a test substance in a test sample irrespective of the amount of the test sample supplied to the assay, and to provide an immunochromatography method using the immunochromatographic test strip. The immunochromatographic test strip includes, in the order from upstream, a sample pad, a labeled substance region, a detection region and an absorption band, wherein a polymer(s) in which hydrophobic cyclic monomer(s) having an ionic functional group(s) is/are polymerized is impregnated at a region(s) upstream of the labeled substance region.

Abstract: Disclosed is a novel method of detecting a test subject by an immunoassay, in which low sensitivity due to using a monoclonal antibody is improved in spite of using a monoclonal antibody in the immunoassay. The method of detecting a test subject is a method of detecting a test subject having two or more kinds of antigens which enable detection of said test subject, which method is performed by an immunoassay such as a sandwich method, using a monoclonal antibody or an antigen-binding fragment thereof which recognizes the two or more kinds of antigens.

Abstract: An object of the present invention is to improve visibility by reducing background noise in order to accurately detect the signal from a target substance in an immunochromatographic device. The immunochromatographic device comprises a membrane having a detection region, to which an antibody or antigen serving as a capturing substance capable of capturing a target substance is immobilized, for detecting the target substance by using an antigen or antibody labeled with a labeling carrier that is a colored particle to form a complex of the capturing substance-target substance-labeled antigen or antibody in the capturing substance-immobilized detection region on the device, based on color of the labeling carrier, wherein a colorant having a color complementary to the color of the labeling carrier is allowed to be contained in a dry state in a constituent member of the device such that the colorant is developed together with a specimen when the specimen is developed on the device.

Abstract: The present invention intends to provide an immunochromatographic test piece that makes it possible to achieve both highly sensitive detection of a substance to be detected and a simple test piece structure, which are usually difficult to be made compatible with each other.