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1.发明申请公开(公告)号：US20070015139A1
公开(公告)日：2007-01-18
申请号：US10538442
申请日：2003-12-15
CPC分类号： C12N1/06 , C12N15/1003 , C12Q1/6806 , C12Q1/6848 , C12Q1/6851 , C12Q1/689 , C12Q2600/16 , C12Q2600/166 , C12Q2545/101
摘要： This invention relates to reagent comprising: any one of cells, viral particles, organelles, parasites, cells comprising organelles, cells comprising viral particles, cells comprising parasites, cells comprising bacterial cells and any combination thereof, the cells, viral particles, organelles or parasites comprising at least one nucleic acid sequence serving as an internal control (IC) target for nucleic acid testing (NAT) assay; wherein the reagent is suitable to be added to a test sample undergoing sample preparation to release, concentrate and/or purify nucleic acids and amplification and/or detection of nucleic acids so as to be used to verify: (i) the efficiency of sample preparation; and (ii) the efficiency of nucleic acid amplification and/or detection. The present invention also relates to a method to verify or validate the preparation and amplification and/or detection of a nucleic acid target sequence in a sample spiked with a reagent of the present invention.
摘要翻译： 本发明涉及试剂，其包含：细胞，病毒颗粒，细胞器，寄生虫，包含细胞器的细胞，包含病毒颗粒的细胞，包含寄生虫的细胞，包含细菌细胞的细胞及其任何组合，细胞，病毒颗粒，细胞器或寄生虫 包括用作核酸测试（NAT）测定的内部对照（IC）靶的至少一个核酸序列; 其中所述试剂适于加入经历样品制备的测试样品以释放，浓缩和/或纯化核酸，并扩增和/或检测核酸，以便用于验证：（i）样品制备的效率 ; 和（ii）核酸扩增和/或检测的效率。 本发明还涉及验证或验证掺有本发明试剂的样品中核酸靶序列的制备和扩增和/或检测的方法。
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2.发明申请Method for the preparation of reagents for amplification and/or detection of nucleic acids that exhibit no significant contamination by nucleic acids 审中-公开用于制备用于扩增和/或检测不显示核酸显着污染的核酸的试剂的方法公开(公告)号：US20050037349A1
公开(公告)日：2005-02-17
申请号：US10469419
申请日：2003-04-11
CPC分类号： C12Q1/6806 , C12Q1/6848 , C12Q2527/125 , C12Q2523/313 , C12Q2531/113
摘要： The present invention decribes reagents free of detectable contaminating nucleic acids for performing highly sensitive and specific nucleic acids amplification and/or detection. It relates to an improvement in the technology of nucleic acid inactivation prior to nucleic acid testing (NAT) in order to prevent false-positive results. Specifically, this invention describes optimized and standardized reagents and ultra-violet treatment to achieve an effective and highly reproducible nucleic acid inactivation prior to NAT without substantially affecting the performance of the assay. More specifically, this nucleic acid inactivation process resulted in a reduction of up to four logs of the background signal associated with the PCR (polymerase chain reaction) amplification of DNA contaminating PCR reagents. This optimized and standardized method is also adaptable for use with NAT technologies other than PCR.
摘要翻译： 本发明描述了不含可检测的污染性核酸的试剂，用于进行高灵敏度和特异性核酸扩增和/或检测。 它涉及核酸测试（NAT）之前的核酸灭活技术的改进，以防止假阳性结果。 具体地，本发明描述了优化的和标准化的试剂和紫外线处理，以在NAT之前实现有效且高度可重现的核酸灭活，而基本上不影响测定的性能。 更具体地，该核酸失活过程导致与DNA污染性PCR试剂的PCR（聚合酶链式反应）扩增相关的背景信号降低多达四个对数。 这种优化和标准化的方法也适用于除PCR以外的NAT技术。
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3.发明授权公开(公告)号：US08183015B2
公开(公告)日：2012-05-22
申请号：US12773581
申请日：2010-05-04
IPC分类号： C12P19/34
CPC分类号： C12N1/06 , C12N15/1003 , C12Q1/6806 , C12Q1/6848 , C12Q1/6851 , C12Q1/689 , C12Q2600/16 , C12Q2600/166 , C12Q2545/101
摘要： This invention relates to reagent comprising: any one of cells, viral particles, organelles, parasites, cells comprising organelles, cells comprising viral particles, cells comprising parasites, cells comprising bacterial cells and any combination thereof, the cells, viral particles, organelles or parasites comprising at least one nucleic acid sequence serving as an internal control (IC) target for nucleic acid testing (NAT) assay; wherein the reagent is suitable to be added to a test sample undergoing sample preparation to release, concentrate and/or purify nucleic acids and amplification and/or detection of nucleic acids so as to be used to verify: (i) the efficiency of sample preparation; and (ii) the efficiency of nucleic acid amplification and/or detection. The present invention also relates to a method to verify or validate the preparation and amplification and/or detection of a nucleic acid target sequence in a sample spiked with a reagent of the present invention.
摘要翻译： 本发明涉及试剂，其包含：细胞，病毒颗粒，细胞器，寄生虫，包含细胞器的细胞，包含病毒颗粒的细胞，包含寄生虫的细胞，包含细菌细胞的细胞及其任何组合，细胞，病毒颗粒，细胞器或寄生虫 包括用作核酸测试（NAT）测定的内部对照（IC）靶的至少一个核酸序列; 其中所述试剂适于加入经历样品制备的测试样品以释放，浓缩和/或纯化核酸，并扩增和/或检测核酸，以便用于验证：（i）样品制备的效率 ; 和（ii）核酸扩增和/或检测的效率。 本发明还涉及验证或验证掺有本发明试剂的样品中核酸靶序列的制备和扩增和/或检测的方法。
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4.发明申请公开(公告)号：US20100233720A1
公开(公告)日：2010-09-16
申请号：US12773581
申请日：2010-05-04
CPC分类号： C12N1/06 , C12N15/1003 , C12Q1/6806 , C12Q1/6848 , C12Q1/6851 , C12Q1/689 , C12Q2600/16 , C12Q2600/166 , C12Q2545/101
摘要： This invention relates to reagent comprising: any one of cells, viral particles, organelles, parasites, cells comprising organelles, cells comprising viral particles, cells comprising parasites, cells comprising bacterial cells and any combination thereof, the cells, viral particles, organelles or parasites comprising at least one nucleic acid sequence serving as an internal control (IC) target for nucleic acid testing (NAT) assay; wherein the reagent is suitable to be added to a test sample undergoing sample preparation to release, concentrate and/or purify nucleic acids and amplification and/or detection of nucleic acids so as to be used to verify: (i) the efficiency of sample preparation; and (ii) the efficiency of nucleic acid amplification and/or detection. The present invention also relates to a method to verify or validate the preparation and amplification and/or detection of a nucleic acid target sequence in a sample spiked with a reagent of the present invention.
摘要翻译： 本发明涉及试剂，其包含：细胞，病毒颗粒，细胞器，寄生虫，包含细胞器的细胞，包含病毒颗粒的细胞，包含寄生虫的细胞，包含细菌细胞的细胞及其任何组合，细胞，病毒颗粒，细胞器或寄生虫 包括用作核酸测试（NAT）测定的内部对照（IC）靶的至少一个核酸序列; 其中所述试剂适于加入经历样品制备的测试样品以释放，浓缩和/或纯化核酸，并扩增和/或检测核酸，以便用于验证：（i）样品制备的效率 ; 和（ii）核酸扩增和/或检测的效率。 本发明还涉及验证或验证掺有本发明试剂的样品中核酸靶序列的制备和扩增和/或检测的方法。
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5.发明授权公开(公告)号：US07718402B2
公开(公告)日：2010-05-18
申请号：US10538442
申请日：2003-12-15
IPC分类号： C12P19/34
CPC分类号： C12N1/06 , C12N15/1003 , C12Q1/6806 , C12Q1/6848 , C12Q1/6851 , C12Q1/689 , C12Q2600/16 , C12Q2600/166 , C12Q2545/101
摘要： This invention relates to reagent comprising: any one of cells, viral particles, organelles, parasites, cells comprising organelles, cells comprising viral particles, cells comprising parasites, cells comprising bacterial cells and any combination thereof, the cells, viral particles, organelles or parasites comprising at least one nucleic acid sequence serving as an internal control (IC) target for nucleic acid testing (NAT) assay; wherein the reagent is suitable to be added to a test sample undergoing sample preparation to release, concentrate and/or purify nucleic acids and amplification and/or detection of nucleic acids so as to be used to verify: (i) the efficiency of sample preparation; and (ii) the efficiency of nucleic acid amplification and/or detection. The present invention also relates to a method to verify or validate the preparation and amplification and/or detection of a nucleic acid target sequence in a sample spiked with a reagent of the present invention.
摘要翻译： 本发明涉及试剂，其包含：细胞，病毒颗粒，细胞器，寄生虫，包含细胞器的细胞，包含病毒颗粒的细胞，包含寄生虫的细胞，包含细菌细胞的细胞及其任何组合，细胞，病毒颗粒，细胞器或寄生虫 包括用作核酸测试（NAT）测定的内部对照（IC）靶的至少一个核酸序列; 其中所述试剂适于加入经历样品制备的测试样品以释放，浓缩和/或纯化核酸，并扩增和/或检测核酸，以便用于验证：（i）样品制备的效率 ; 和（ii）核酸扩增和/或检测的效率。 本发明还涉及验证或验证掺有本发明试剂的样品中核酸靶序列的制备和扩增和/或检测的方法。
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