公开(公告)号：US20210010072A1

公开(公告)日：2021-01-14

申请号：US16766125

申请日：2018-11-22

申请人： Koei SUZUKI ,  Hirotaka UNNO ,  Manabu SEO ,  Satoshi IZUMI ,  Yusuke OSAKI ,  Yudai KAWASHIMA ,  Michie HASHIMOTO

发明人： Koei SUZUKI ,  Hirotaka UNNO ,  Manabu SEO ,  Satoshi IZUMI ,  Yusuke OSAKI ,  Yudai KAWASHIMA ,  Michie HASHIMOTO

IPC分类号： C12Q1/6851 ,  C12Q1/686

摘要： 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.

公开(公告)号：US20210147906A1

公开(公告)日：2021-05-20

申请号：US16766117

申请日：2018-11-22

申请人： Yusuke OSAKI ,  Satoshi IZUMI ,  Yudai KAWASHIMA ,  Michie HASHIMOTO ,  Manabu SEO ,  Koei SUZUKI ,  Hirotaka UNNO

发明人： Yusuke OSAKI ,  Satoshi IZUMI ,  Yudai KAWASHIMA ,  Michie HASHIMOTO ,  Manabu SEO ,  Koei SUZUKI ,  Hirotaka UNNO

IPC分类号： C12Q1/6806 ,  B01L3/02 ,  C12Q1/689 ,  C12Q1/70

摘要： 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.

公开(公告)号：US20210309958A1

公开(公告)日：2021-10-07

申请号：US16763161

申请日：2018-11-13

申请人： Satoshi IZUMI ,  Manabu SEO ,  Yudai KAWASHIMA ,  Yusuke OSAKI

发明人： Satoshi IZUMI ,  Manabu SEO ,  Yudai KAWASHIMA ,  Yusuke OSAKI

IPC分类号： C12M1/00 ,  C12M1/32 ,  C12Q1/6851

摘要： Provided is a device including at least one well and an amplifiable reagent contained in a specific copy number in the at least one well. In a preferable mode, the device includes information on the specific copy number of the amplifiable reagent. In a more preferable mode, the device includes information on uncertainty as the information on the specific copy number, and the information on uncertainty includes a coefficient of variation CV of the amplifiable reagent, and the coefficient of variation CV satisfies a relational expression: CV

公开(公告)号：US20240093282A1

公开(公告)日：2024-03-21

申请号：US18359706

申请日：2023-07-26

申请人： Yusuke OSAKI ,  Yuuki Yonekawa ,  Michie Hashimoto ,  Hirotaka Unno

发明人： Yusuke OSAKI ,  Yuuki Yonekawa ,  Michie Hashimoto ,  Hirotaka Unno

IPC分类号： C12Q1/6851 ,  B01L3/00 ,  B01L7/00 ,  C12Q1/70

CPC分类号： C12Q1/6851 ,  B01L3/502707 ,  B01L3/502715 ,  B01L7/52 ,  C12Q1/701 ,  B01L2200/12 ,  B01L2200/16 ,  B01L2300/18 ,  C12Q2600/166

摘要： 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.

公开(公告)号：US20230011171A1

公开(公告)日：2023-01-12

申请号：US17810075

申请日：2022-06-30

申请人： Yusuke OSAKI ,  Satoshi Nakazawa ,  Yuuki Yonekawa ,  Hirotaka Unno ,  Michie Hashimoto ,  Masunori Kajikawa

发明人： Yusuke OSAKI ,  Satoshi Nakazawa ,  Yuuki Yonekawa ,  Hirotaka Unno ,  Michie Hashimoto ,  Masunori Kajikawa

IPC分类号： C12Q1/6848

摘要： 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.

公开(公告)号：US20230168263A1

公开(公告)日：2023-06-01

申请号：US18159987

申请日：2023-01-26

申请人： Hirotaka UNNO ,  Satoshi NAKAZAWA ,  Yuuki YONEKAWA ,  Yunong JI ,  Yusuke OSAKI

发明人： Hirotaka UNNO ,  Satoshi NAKAZAWA ,  Yuuki YONEKAWA ,  Yunong JI ,  Yusuke OSAKI

IPC分类号： G01N35/00

CPC分类号： G01N35/00623 ,  G01N2035/00653

摘要： 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.