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：US20230295702A1

公开(公告)日：2023-09-21

申请号：US18147149

申请日：2022-12-28

申请人： Yuuki Yonekawa ,  Hirotaka Unno ,  Satoshi Nakazawa ,  Yunong Ji ,  Kazusa DNA Research Institute

发明人： Yuuki YONEKAWA ,  Hirotaka UNNO ,  Satoshi NAKAZAWA ,  Yunong JI ,  Sakae ITOGA

IPC分类号： C12Q1/6851 ,  C12Q1/6844

CPC分类号： C12Q1/6851 ,  C12Q1/6844

摘要： 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.

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.

公开(公告)号：US20220170076A1

公开(公告)日：2022-06-02

申请号：US17455971

申请日：2021-11-22

申请人： Hirotaka Unno ,  Satoshi Nakazawa ,  Yuuki Yonekawa ,  Michie Hashimoto ,  Fasmac Co., Ltd.

发明人： Hirotaka UNNO ,  Satoshi Nakazawa ,  Yuuki Yonekawa ,  Michie Hashimoto ,  Satoshi Futo ,  Mari Onishi ,  Riztyan

IPC分类号： C12Q1/6806 ,  G01N21/64

摘要： 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.