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    • 4. 发明公开
    • BIOLOGICAL INDICATOR
    • 生物指标
    • EP3206723A1
    • 2017-08-23
    • EP15747598.9
    • 2015-06-16
    • American Sterilizer Company
    • FRANCISKOVICH, Phillip P.CREGGER, Tricia A.YIRAVA, William A.BURKE, Peter A.
    • A61L2/28C12M1/34C12Q1/68
    • C12N15/75A61L2/28C12M1/34C12M37/06C12N9/2471C12Q1/22C12Q1/34C12Q1/689C12Q1/6897C12Y302/01023
    • 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.
    • 本发明涉及由组合物衍生的生物指示物,所述组合物包含:包含孢子形成细菌的宿主生物体; 用于产生指示酶的报道基因; 一个调控基因; 以及用于将报道基因和调控基因插入宿主生物体的载体; 宿主生物在其基因组中携带可转座的遗传元件,用于在调控基因中插入插入序列; 插入序列包含转座酶,一对末端反向重复序列和至少一个用于表达转座酶的开放阅读框。 该载体可以被宿主生物吸收。 插入序列可以插入调节基因中。 宿主生物可以进行孢子形成生物指示物。 公开了使用生物指示剂的方法和设备。
    • 6. 发明公开
    • STERILIZATION INDICATOR INCLUDING A SIMPLIFIED GENETICALLY ENGINEERED BIOLOGICAL INDICATOR
    • 杀菌剂麻醉药物维生素E基因产物
    • EP2970992A1
    • 2016-01-20
    • EP14709493.2
    • 2014-02-24
    • American Sterilizer Company
    • FRANCISKOVICH, Phillip P.CREGGER, Tricia A.YIRAVA, William A.
    • C12N15/75C12Q1/22G01N33/52
    • C12Q1/22C12N15/74C12N15/75
    • 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.
    • 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后; 其中所述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道基因,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为使得指示酶的酶作用 酶底物产生可检测信号。
    • 10. 发明公开
    • COMBINED STERILIZATION INDICATOR INCUBATOR AND READER SYSTEM
    • 联合灭菌指示器培养器和读数器系统
    • EP3074523A1
    • 2016-10-05
    • EP14772254.0
    • 2014-09-10
    • American Sterilizer Company
    • FRANCISKOVICH, Phillip P.CREGGER, Tricia A.VODKIN, Paul
    • C12Q1/22A61L2/28G01N31/22
    • C12Q1/22A61L2/28
    • A combined sterilization indicator incubator and reader system, including a sterilization indicator vial containing one of a variety of selected biological indicators and a liquid, at least two incubator blocks, each incubator block independently operable to incubate the sterilization indicator vial at a plurality of independently selectable temperatures, each of the incubator blocks including at least one heating element operable to heat the incubator block to any one of the plurality of independently selectable temperatures; a light source, a photodetector and a control system configured to operate the combined system to determine the efficacy of a variety of sterilization processes. The system calculates and compares a slope to a predetermined threshold slope for the biological indicator, and provides output based only on the comparison of the calculated slope to the predetermined threshold slope without first determining either a baseline or a minimum value of the output from the photodetector.
    • 包括灭菌指示器小瓶的组合灭菌指示器培养器和读取器系统包括各种所选生物指示器和液体中的一种的灭菌指示器小瓶,至少两个培养器模块,每个培养器模块独立地可操作以培育灭菌指示器小瓶以多个可独立选择 温度,每个所述培养箱包括至少一个加热元件,所述加热元件可操作以将所述培养箱加热至所述多个可独立选择的温度中的任何一个; 光源,光电检测器和控制系统,其被配置为操作组合系统以确定各种消毒过程的功效。 系统计算并比较斜率与生物指标的预定阈值斜率,并且仅基于计算的斜率与预定阈值斜率的比较提供输出,而不首先确定来自照片的输出的基线或最小值 探测器。