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: A carrier includes a supporting part on which a specific number of cells A are supported. The cells A contain a specific number of copies of a nucleic acid, and the supporting part is made of a water-decomposable material.

Abstract: A method of determining a limit of detection and a limit of quantitation in a nucleic acid detection test is provided, the method including, by using a container having a specific configuration, adding a negative specimen that does not contain target nucleic acids to a positive control group and adding a reagent used for a nucleic acid detection test to a negative control group and the positive control group to amplify the target nucleic acids, and determining a smallest specific copy number among specific copy numbers with a detection rate of 95% or greater in the positive control group as a limit of detection and determining a smallest specific copy number among specific copy numbers with CVln of 35% or less as a limit of quantitation in a case where the target nucleic acids are not detected in the negative control group.

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: An information provision device includes an acquisition unit and an information output unit. The acquisition unit acquires test result data indicating a Cq value of a well obtained by a test device performing a polymerase chain reaction (PCR) test on a standard device having the well in which a known number of copies of a nucleic acid are disposed. The information output unit outputs comparison information obtained by comparing information obtained from evaluation target data that is the evaluation target data of an evaluation target with information obtained from one or more pieces of the test result data different from the evaluation target 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: A carrier includes a supporting part on which a specific number of cells A are supported. The cells A contain a specific number of copies of a nucleic acid, and the supporting part is made of a water-decomposable material.

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 a nucleic acid detection cassette, a predetermined syringe is crushed to supply a sample solution to an amplification unit via a channel and the amplification unit is heated from outside to amplify sample DNA in the sample solution. The sample solution containing an amplification product is supplied to a detection unit via the channel and a hybridization reaction occurs in the detection unit. Next, another syringe is crushed and an intercalating agent solution is supplied via another predetermined channel. Therefore, a nucleic acid detection cassette capable of automation from amplification of a sample to detection of an electrochemical reaction of the sample is provided.

Abstract: Provided is a technique capable of adequately presenting the product specifications of a material sample even when the concentration distribution of the material is asymmetrical. A material sample according to the present disclosure stores a material having variation according to a probability distribution. As the product specifications of the material sample, the representative value of the probability distribution as well as an interval in which the amount of the material is greater than or equal to a target probability on the probability distribution is displayed.

Abstract: A nucleic acid inspection apparatus has an installer to install a nucleic acid inspection device, the installer comprising a storage unit to store at least a specimen sample, an amplifier to amplify nucleic acid contained in the specimen sample stored in the storage unit, a first flow passage to move the specimen sample from the storage unit to the amplifier, an inspection unit, and a second flow passage to move the specimen sample from the amplifier to the inspection unit, a first opening/closing unit to open/close the first flow passage, a second opening/closing unit to open/close the second flow passage, a heater to heat the amplifier, and a controller to control the first and second opening/closing units so as to open/close in a predetermined order and to control the heater so as to heat the amplifier in conjunction with opening/closing operations of the first and second opening/closing units.

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: In a nucleic acid detection cassette, a predetermined syringe is crushed to supply a sample solution to an amplification unit via a channel and the amplification unit is heated from outside to amplify sample DNA in the sample solution. The sample solution containing an amplification product is supplied to a detection unit via the channel and a hybridization reaction occurs in the detection unit. Next, another syringe is crushed and an intercalating agent solution is supplied via another predetermined channel. Therefore, a nucleic acid detection cassette capable of automation from amplification of a sample to detection of an electrochemical reaction of the sample is provided.

Abstract: A nucleic acid inspection apparatus has an installer to install a nucleic acid inspection device, the installer comprising a storage unit to store at least a specimen sample, an amplifier to amplify nucleic acid contained in the specimen sample stored in the storage unit, a first flow passage to move the specimen sample from the storage unit to the amplifier, an inspection unit, and a second flow passage to move the specimen sample from the amplifier to the inspection unit, a first opening/closing unit to open/close the first flow passage, a second opening/closing unit to open/close the second flow passage, a heater to heat the amplifier, and a controller to control the first and second opening/closing units so as to open/close in a predetermined order and to control the heater so as to heat the amplifier in conjunction with opening/closing operations of the first and second opening/closing units.

Abstract: According to one embodiment, a liquid feed device includes a support substrate and an intermediate member. The intermediate member is provided on the support substrate. A valve and a flow channel of fluid are formed by the intermediate member. The valve communicates with the flow channel. The valve includes an outer edge portion and a gap. The gap is provided between the outer edge portion and the support substrate. The valve is capable of opening and closing the gap by the outer edge portion being pressed and released. A configuration of the outer edge portion when projected onto a plane perpendicular to a direction of the flow channel is a protruding configuration having a curved surface. The configuration of the outer edge portion is symmetric with respect to the direction of the flow channel.

Abstract: On the peripheral edge of a front side substrate of an FED, a rectangular frame shaped sealing surface is formed for sealing a sidewall. On the sealing surface, an indium layer is formed through a base layer. At the four corners of the indium layer, an electrode for applying an electric current is connected. The indium layer is formed to have a width gradually decreasing from substantially the center of each side of the sealing surface to adjacent corners.