Patent
An object of the present invention is to provide a detection marker that can simply and rapidly detect Mycoplasma pneumoniae , which is a pathogen of mycoplasma pneumonia, at a high sensitivity, a specific antibody against the marker, and also an immunological detection method and a kit containing the antibody. Infection with Mycoplasma pneumoniae can be rapidly and specifically diagnosed by producing an antibody specifically reactive to P30 protein of Mycoplasma pneumoniae and performing an immunological assay using the P30 protein as a detection marker. The present invention enables easy and rapid detection of Mycoplasma pneumoniae and diagnosis of infection with the bacteria at a hospital or the like without need of specialized instruments or skilled techniques.
1. A sandwich immunoassay kit for detecting Mycoplasma pneumoniae in a biological sample, at least comprising first and second antibodies against P30 protein of Mycoplasma pneumoniae , wherein at least one of the first and second antibodies is a monoclonal antibody recognizing an epitope of P30 protein present in a region of the amino acid sequence of SEQ ID NO: 2.
2. The sandwich immunoassay kit according to claim 1 , wherein the sandwich immunoassay is an ELISA or immunochromatographic assay.
3. An immunochromatographic test strip for detecting Mycoplasma pneumoniae in a test sample, at least comprising first and second antibodies against P30 protein of Mycoplasma pneumoniae and a membrane carrier,
wherein the first antibody is previously immobilized at a predetermined position of the membrane carrier so as to form a capturing zone; and
the second antibody is labeled with an appropriate labeling substance and is provided at a position separated from the capturing zone so as to be chromatographically developed in the membrane carrier, whereby when the test sample is added to reach the above position, a complex of an antigen contained in the test sample and the second antibody is captured by the capturing zone,
wherein at least one of the first and second antibodies is a monoclonal antibody recognizing an epitope of P30 protein present in a region of the amino acid sequence of SEQ ID NO: 2, and
the test sample is a biological sample.
4. The immunochromatographic test strip according to claim 3 , wherein the second antibody is labeled with a colloidal metal or a latex.
5. The immunochromatographic test strip according to claim 4 , wherein the membrane carrier is a nitrocellulose membrane.
6. The sandwich immunoassay kit according to claim 1 , wherein the biological sample is at least one selected from the group consisting of nasal cavity aspirate, nasal cavity swab, throat swab, sputum, saliva, and bronchial washings.
7. The immunochromatographic test strip according to claim 3 , wherein the biological sample is at least one selected from the group consisting of nasal cavity aspirate, nasal cavity swab, throat swab, sputum, saliva, and bronchial washings.