Biological indicator
    1.
    发明授权

    公开(公告)号:US10011843B2

    公开(公告)日:2018-07-03

    申请号:US15618156

    申请日:2017-06-09

    Abstract: This invention relates to a biological indicator derived from a composition comprising: a host organism comprising a spore forming bacteria; a reporter gene for producing an indicator enzyme; a regulatory gene; and a vehicle for inserting the reporter gene and the regulatory gene in the host organism; the host organism bearing a transposable genetic element in its genome for inserting an insertion sequence in the regulatory gene; the insertion sequence comprising a transposase, a pair of terminal inverted repeat sequences, and at least one open reading frame for expressing the transposase. The vehicle may be taken up by the host organism. The insertion sequence may be inserted in the regulatory gene. The host organism may undergo sporulation to form the biological indicator. A process and an apparatus for using the biological indicator are disclosed.

    Sterilization indicator including a simplified genetically engineered biological indicator
    2.
    发明授权
    Sterilization indicator including a simplified genetically engineered biological indicator 有权
    消毒指示剂包括简化的基因工程生物指示剂

    公开(公告)号:US08945837B2

    公开(公告)日:2015-02-03

    申请号:US13832019

    申请日:2013-03-15

    CPC classification number: C12Q1/22 C12N15/74 C12N15/75

    Abstract: A sterilization indicator, including a first compartment containing a genetically engineered biological indicator, and a second compartment containing an enzyme substrate, the second compartment adapted to maintain the enzyme substrate separate from the biological indicator during sterilization, and to permit the enzyme substrate to contact the biological indicator after the biological indicator has been exposed to the sterilization medium; in which the genetically engineered biological indicator comprises at least one test organism and at least one reporter gene suitable for producing an indicator enzyme, the reporter gene being taken up by the test organism; and the test organism is free of any active or activatable repressor gene that would inhibit expression of the reporter gene if present in the test organism or sterilization indicator, and the indicator enzyme and the enzyme substrate are selected such that enzymatic action of the indicator enzyme upon the enzyme substrate yields a detectable signal.

    Abstract translation: 灭菌指示剂,包括含有遗传工程生物指示剂的第一隔室和含有酶底物的第二隔室,所述第二隔室适于在灭菌期间将酶底物与生物指示剂分离,并允许酶底物接触 生物指示剂在生物指示剂暴露于灭菌介质之后; 其中遗传工程生物指示剂包含至少一种测试生物体和至少一种适于产生指示酶的报告基因,所述报道基因被测试生物体吸收; 并且测试生物体没有任何活性或可激活的阻遏物基因,如果存在于测试生物体或灭菌指示剂中,则抑制报告基因的表达,并且指示酶和酶底物被选择使得指示酶的酶作用 酶底物产生可检测信号。

    Biological indicator
    5.
    发明授权

    公开(公告)号:US10301631B2

    公开(公告)日:2019-05-28

    申请号:US16001203

    申请日:2018-06-06

    Abstract: This invention relates to a biological indicator derived from a composition comprising: a host organism comprising a spore forming bacteria; a reporter gene for producing an indicator enzyme; a regulatory gene; and a vehicle for inserting the reporter gene and the regulatory gene in the host organism; the host organism bearing a transposable genetic element in its genome for inserting an insertion sequence in the regulatory gene; the insertion sequence comprising a transposase, a pair of terminal inverted repeat sequences, and at least one open reading frame for expressing the transposase. The vehicle may be taken up by the host organism. The insertion sequence may be inserted in the regulatory gene. The host organism may undergo sporulation to form the biological indicator. A process and an apparatus for using the biological indicator are disclosed.

    Biological indicator
    6.
    发明授权

    公开(公告)号:US10017772B2

    公开(公告)日:2018-07-10

    申请号:US15618158

    申请日:2017-06-09

    Abstract: This invention relates to a biological indicator derived from a composition comprising: a host organism comprising a spore forming bacteria; a reporter gene for producing an indicator enzyme; a regulatory gene; and a vehicle for inserting the reporter gene and the regulatory gene in the host organism; the host organism bearing a transposable genetic element in its genome for inserting an insertion sequence in the regulatory gene; the insertion sequence comprising a transposase, a pair of terminal inverted repeat sequences, and at least one open reading frame for expressing the transposase. The vehicle may be taken up by the host organism. The insertion sequence may be inserted in the regulatory gene. The host organism may undergo sporulation to form the biological indicator. A process and an apparatus for using the biological indicator are disclosed.

    BIOLOGICAL INDICATOR
    8.
    发明申请

    公开(公告)号:US20200063178A1

    公开(公告)日:2020-02-27

    申请号:US16106870

    申请日:2018-08-21

    Abstract: This invention relates to a biological indicator for use with a sterilization process, comprising a carrier on which an inoculum is placed and dehydrated, the inoculum comprising a test organism in the form of bacterial spores and an effective amount of an excipient to enhance recovery of the bacterial spores from the dehydrated inoculum. In an embodiment, the inoculum further comprises a carbohydrate.

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