Abstract: The present invention has an object to develop and provide a target nucleic acid detection device having a low copy number of IPC nucleic acids placed therein, and a method for producing the device, to avoid a decrease caused in the detection sensitivity to a target nucleic acid through competitive inhibition of the target nucleic acid by addition of an internal positive control (IPC) nucleic acid. Provided is a target nucleic acid detection device in which a low copy number of IPC nucleic acids that do not inhibit the amplification reaction of a target nucleic acid is preliminarily placed in a reaction well.

Abstract: In one embodiment, provided are a method for analyzing at least one nucleic acid that can conveniently and highly accurately analyze even a very small number of analyte at least one nucleic acid. In one embodiment, the present invention relates to a method for analyzing at least one nucleic acid, comprising: a library preparation step of preparing a library comprising at least one standard nucleic acid of specific copy number(s) and at least one analyte nucleic acid in a same system; a calibration curve data generation step of generating calibration curve data based on the copy number(s) of the at least one standard nucleic acid of specific copy number(s); and an analyte nucleic acid analysis step of identifying at least one nucleotide sequence of the analyte nucleic acid while identifying the number(s) of the at least one nucleotide sequence of the at least one analyte nucleic acid using the calibration curve data.

Abstract: A sample for evaluating performance of a genetic testing apparatus includes, a nucleic acid A; and a nucleic acid B, in which the nucleic acid A and the nucleic acid B have mutually different sequences. The nucleic acid A contains a specific number of molecules, and the nucleic acid B contains a number of molecules higher than the number of molecules of the nucleic acid A. A ratio A/B of the number of molecules of the nucleic acid A with respect to the number of molecules of the nucleic acid B is specified.

Abstract: A method for manufacturing a device is provided, in which a known quantity of a reagent is reliably immobilized in a reaction field, which can be stored at room temperature, and with which the performance of a real-time PCR apparatus can be correctly evaluated. The method is a method for manufacturing a device having at least one well, in which a specific number of copies of a nucleic acid in the at least one well are immobilized in a reaction field. The method includes a nucleic acid extraction step of extracting the nucleic acid with an enzyme and a drying deactivation step of deactivating the enzyme by drying at 5° C. to 45° C.

Abstract: Provided is a device including a well provided in a number of at least one, wherein a nucleic acid having at least one of a full-length nucleotide sequence and a partial nucleotide sequence of rRNA or rDNA is contained in a defined copy number in at least one well of the well, and wherein the defined copy number of the nucleic acid having at least one of a full-length nucleotide sequence and a partial nucleotide sequence of rRNA or rDNA is 1,000 or less.

Abstract: Provided is a detection determining method used in detection of a testing target in a sample by amplification of the testing target and an amplifiable reagent, wherein the amplifiable reagent is provided in a number of 200 or less, the detection determining method including a determining step of determining that the testing target is present and a detection result is positive when the amplifiable reagent is amplified and the testing target is amplified, and determining that the testing target is absent or at least less than a specific copy number of the amplifiable reagent and a detection result is negative when the amplifiable reagent is amplified and the testing target is not amplified. Also provided are a detection determining device, a detection determining program, and a device used for the detection determining method.

Abstract: Provided is a device including: a plurality of wells; a reagent composition located in each of the wells and containing an amplifiable reagent in a specific copy number; and two or more groups into which the wells are divided to have the amplifiable reagent located in the same specific copy number but to be varied in composition of the reagent composition except for the specific copy number. Preferably, composition except for the specific copy number of the amplifiable reagent includes at least any one of primer and amplifying reagent. More preferably, the device includes two or more groups varied in the specific copy number. Yet more preferably, the groups of wells include at least a negative control group in which the specific copy number of the amplifiable reagent is 0, and a group in which the specific copy number of the amplifiable reagent is close to the limit of detection.

Abstract: Provided is a detection determining device used in a detection determining method including, in detection of a testing target in a sample by amplification of the testing target and an amplifiable reagent, determining that the testing target is present and a detection result is positive when the amplifiable reagent is amplified and the testing target is amplified, and determining that the testing target is absent or at least less than a specific copy number of the amplifiable reagent and a detection result is negative when the amplifiable reagent is amplified and the testing target is not amplified, the detection determining device including at least one well, wherein the amplifiable reagent in the at least one well is contained in a specific copy number.

Abstract: In one embodiment, provided are a method for analyzing at least one nucleic acid that can conveniently and highly accurately analyze even a very small number of analyte at least one nucleic acid. In one embodiment, the present invention relates to a method for analyzing at least one nucleic acid, comprising: a library preparation step of preparing a library comprising at least one standard nucleic acid of specific copy number(s) and at least one analyte nucleic acid in a same system; a calibration curve data generation step of generating calibration curve data based on the copy number(s) of the at least one standard nucleic acid of specific copy number(s); and an analyte nucleic acid analysis step of identifying at least one nucleotide sequence of the analyte nucleic acid while identifying the number(s) of the at least one nucleotide sequence of the at least one analyte nucleic acid using the calibration curve data.

Abstract: Embodiments relate to a method of analyzing nucleic acid. The nucleic acid analysis method includes subjecting a sample to an amplifying reaction using first and second primers, reacting an amplification product with a nucleic acid probe, measuring presence/absence of hybridization and/or a quantity thereof, and determining presence/absence of a target nucleic acid in the sample and/or a quantity of target nucleic acid. The amplification product obtained with the first or second primer forms a stem-and-loop structural body. With the detection of the presence/absence of the hybridization between a nucleic acid probe for the loop structure and the amplification product, and/or the amount thereof, the nucleic acid analysis is carried out on the sample.

Abstract: Provided is a nucleic acid primer for LAMP amplification for use in the detection of human papilloma virus and identification of its genotype. The present invention also provides a method of detecting human papilloma virus and identifying its genotype, includes a step of amplifying the nucleic acid chains in a sample in LAMP reaction by using multiple primers including at least one primer selected from the nucleic acid primers according to the present invention and a step of detecting presence of amplified products after the amplification reaction and identifying their genotypes.

Abstract: The invention provides a method of detecting a drug-resistant strain of hepatitis B virus, including amplifying a hepatitis B virus nucleic acid in a sample solution by LAMP with a primer set to yield an amplification product, and hybridizing the amplification product with a probe containing a polynucleotide derived from a drug-resistant strain and/or a probe containing a polynucleotide derived from a drug-nonresistant strain, to detect a drug-resistant strain of hepatitis B virus.

Abstract: The present invention provides a method of predicting potential severity of hepatitis, includes determining that hepatitis in a subject is potentially severe when it is detected that any amino acid is mutated to an amino acid of genotype-4, the any amino acid being amino acid of an amino acid sequence in a region encoded by ORF1 of an HEV genome RNA of genotype 3, and the HEV genome RNA being contained in a specimen nucleic acid taken from the subject infected with genotype-3 HEV.

Abstract: Provided is a nucleic acid primer for LAMP amplification for use in the detection of human papilloma virus and identification of its genotype. The present invention also provides a method of detecting human papilloma virus and identifying its genotype, includes a step of amplifying the nucleic acid chains in a sample in LAMP reaction by using multiple primers including at least one primer selected from the nucleic acid primers according to the present invention and a step of detecting presence of amplified products after the amplification reaction and identifying their genotypes.

Abstract: The present invention provides methods for obtaining information regarding nucleic acid from an individual and nucleic acid associated with a disease of the individual, in particular when the disease is associated with a pathogenic microorganism present within the individual. The present invention also provide probe-immobilized substrates, such as probe-immobilized chips, for use in the methods. In particular, the present invention provides methods and probe-immobilized substrates for obtaining information regarding responsiveness to a treatment for a disease of an individual.

Abstract: There is provided a marker selection program for selecting a marker for use in genetic diagnosis. In the program, analysis is carried out by using at least two specimen databases which respectively store data of specimens belonging different populations. By carrying out analysis without integrating all specimen data into single population, information on a minority population can be surely reflected to a gene search. Since the characteristics of each population can be reflected, high-accuracy diagnosing functions can be obtained, providing a practical diagnosing system.

Abstract: A polynucleotide probe that has a sequence of at least 8 nucleotides which can be hybridized with nucleotides from the hepatitis E virus JRA 1; a probe assay kit that includes the polynucleotide probe; and a chip on which the polynucleotide probe has been solid-phase fixed.

Abstract: A polynucleotide probe that has a sequence of at least 8 nucleotides and is used for detecting at least one hepatitis E virus selected from JSN-FH, JKN-Sap, JMY-Haw, JAK-Sai, and JRA1; a probe assay kit that includes the polynucleotide probe; and a chip on which the polynucleotide probe has been solid-phase fixed.

Abstract: The present invention provides a polymorphic marker found in a region of the interferon receptor gene that can be used to assess the efficacy of interferon therapy. Thus, the present invention also relates to methods of assessing the efficacy of interferon therapy in an individual and means for accomplishing such a method.

Abstract: A polynucleotide probe including a sequence comprising at least eight nucleotides, the polynucleotide probe being used for detecting polynucleotide of hepatitis E virus, is characterized in that the sequence comprising at least eight nucleotides is hybridized with the polynucleotide of the hepatitis E virus, thereby, due to the hybridization, detects the hepatitis E virus.