- 专利标题: METHOD OF DETERMINING LIMIT OF DETECTION AND LIMIT OF QUANTITATION IN NUCLEIC ACID DETECTION TEST
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申请号: US18147149申请日: 2022-12-28
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公开(公告)号: US20230295702A1公开(公告)日: 2023-09-21
- 发明人: Yuuki YONEKAWA , Hirotaka UNNO , Satoshi NAKAZAWA , Yunong JI , Sakae ITOGA
- 申请人: Yuuki Yonekawa , Hirotaka Unno , Satoshi Nakazawa , Yunong Ji , Kazusa DNA Research Institute
- 申请人地址: JP Tokyo
- 专利权人: Ricoh Company, Ltd.,Kazusa DNA Research Institute
- 当前专利权人: Ricoh Company, Ltd.,Kazusa DNA Research Institute
- 当前专利权人地址: JP Tokyo; JP Kisarazu-shi
- 优先权: JP 22043676 2022.03.18
- 主分类号: C12Q1/6851
- IPC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.
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