Abstract: A self-contained biological sterilization indicator comprises: a housing; bacterial spores comprising, and/or capable of producing, an enzyme capable of catalyzing cleavage of an enzyme substrate; and a frangible container containing a composition, wherein the composition comprises the enzyme substrate, wherein if the frangible container is broken the composition will contact the bacterial spores to form a mixture having an initial pH in the range from 6.0 to 9.0. The enzyme substrate comprises a fluorinated 4?-alkylumbelliferyl ?-D-glucopyranoside represented by the structural formula (I) wherein one of R1 and R2 is F and the other is H, and R3 is an alkyl group having from 1 to 12 carbon atoms. A biological sterilization indicator comprising a kit containing isolated components comprising (i) bacterial spores comprising, and/or capable of producing, an enzyme capable of catalyzing cleavage of the enzyme substrate and a method of assessing efficacy of a sterilization process are also disclosed.

Abstract: A protected sample collection media for use in a sample collection device includes a piece of porous sample collection media having a first major side and an opposing second major side; and a protective sheath fully covering the first major side and the second major side. The protective sheath has a first portion and a second portion. The first portion is removable without removing the second portion. The second portion forms a tab constructed to be gripped by hand. The protected sample collection media may be part of a system including a sample collection device. The system may be provided as a kit including instructions for use of the kit.

Abstract: A sample collection device includes a housing including an exhalation portion and a coupling portion. The coupling portion can be coupled with/to a sample collection tube. An airflow path extends through the housing. The device further includes porous sample collection media partially disposed between within the housing and arranged to occlude the airflow path. The porous sample collection includes nonwoven material and may include polylactic acid, polypropylene, or a combination thereof. The housing can be a single piece, part, or component, or can be multiple pieces, parts, components, or portions. In an embodiment of a two-piece housing, the first part includes an exhalation piece (e.g., a mouthpiece or nosepiece) and the second part includes a coupling end constructed for coupling with a sample collection tube.

Abstract: An article includes a flexible structured film with a first major surface and a second major surface, wherein a first major surface of the flexible structured film has a plurality of posts separated by land areas, and the posts have an exposed surface. An anti-biofouling layer resides in the land areas, and the anti-biofouling layer has a methylated surface. An inorganic layer is on the exposed surfaces of the posts, wherein the inorganic layer includes a metal or a metal oxide. An analyte binding layer is on the inorganic layer, wherein the analyte binding layer is chosen from a reactive silane, a functionalizable hydrogel, a functionalizable polymer, and mixtures and combinations thereof. An exposed surface of the analyte binding layer includes at least one functional group selected to bind with a biochemical analyte.

Abstract: A chlorinated 4?-alkylumbelliferyl ?-D-glucopy-ranoside represented by the structural formula (I) One of R1 and R2 is Cl and the other is H. R3 represents an alkyl group having 1 to 12 carbon atoms. A method of assessing efficacy of a sterilization process including the same is also disclosed.

Abstract: A sample collection device includes a housing extending from a mouthpiece end to an air outlet end, the housing defining an airflow channel from the mouthpiece end to the air outlet end, the mouthpiece end configured to receive an exhalation airflow. A porous sample collection media is fixed within the housing and along the airflow channel. A mouthpiece end cap is replaceably coupled to the mouthpiece end and an air outlet end cap is replaceably coupled to the air outlet end.

Abstract: An article includes a flexible structured film with a first major surface and a second major surface, wherein a first major surface of the flexible structured film has a plurality of posts separated by land areas, and the posts have an exposed surface. An anti-biofouling layer resides in the land areas, and the anti-biofouling layer has a methylated surface. An inorganic layer is on the exposed surfaces of the posts, wherein the inorganic layer includes a metal or a metal oxide. An analyte binding layer is on the inorganic layer, wherein the analyte binding layer is chosen from a reactive silane, a functionalizable hydrogel, a functionalizable polymer, and mixtures and combinations thereof. An exposed surface of the analyte binding layer includes at least one functional group selected to bind with a biochemical analyte.

Abstract: An article includes a flexible carrier film with a first major surface having an array of structures, at least a portion of which include an inorganic layer and an analyte binding layer. The analyte binding is bonded to the inorganic layer via a network of hydrocarbon linking groups, and the analyte binding layer includes at least one functional group selected to bind with a biochemical analyte. Recessed features interspersed with the structures are free of the inorganic layer and the analyte binding layer.

Abstract: An article for assessing efficacy of a sterilization process is provided. The article includes a housing, a plurality of genetically-modified spore-forming test microorganisms disposed in the housing, a liquid medium disposed in an openable container that is disposed in or attached to the housing, and an enzyme substrate disposed in the housing or in the openable container. The genetically-modified test microorganism comprises a functional fusion gene that encodes a non-naturally occurring chimeric protein, the chimeric protein comprising a first segment and a second segment that is contiguous with the first segment. The first segment comprises at least a portion of a first polypeptide that is normally found in spores and the second segment comprises a second polypeptide having a detectable enzymatic activity. The enzyme substrate is capable of reacting with the detectable enzyme activity to form a detectable product. A method of using the test microorganisms is also provided.

Abstract: Primers and methods of amplifying DNA from shiga toxins stx1 and stx2 designed for use in a multiplex method and useful in detecting shiga-toxin producing E. Coli (STEC). The primers being especially designed for use in Loop-mediated Isothermal Amplification (LAMP).

Abstract: Primers and primer sets for amplification of Vibrio parahaemolyticus DNA and methods of detecting Vibrio parahaemolyticus using the primers and primer sets.

Abstract: An article is provided. The article comprises a nonwoven substrate having a copolymer grafted thereto, and a dried coating adhered to the substrate. The copolymer comprises interpolymerized monomer units of a quaternary ammonium-containing ligand monomer, an amide monomer, and an oxy monomer. The coating comprises a plurality of test microorganisms. Optionally, the coating further comprises a water-soluble or water-dispersible polymeric binding agent. A process challenge device comprising a body having a hollow channel with said article fixed disposed therein is also provided. Methods of using the article or the process challenge device for determining the efficacy of a disinfection process are also provided.

Abstract: A recycling optical cavity is defined at least by first and second optical films and is configured to receive a test material therein. The test material is configured to emit at least a second light having a second wavelength when irradiated with a first light having a first wavelength. For at least one of s- and p-polarized incident lights incident in an incident plane, and at the first and second wavelengths: at a first incident angle, the first optical film has respective optical transmittances T11(?1) and T12(?1), and the second optical film has respective optical transmittances T21(?1) and T22(?1), wherein T11(?1)>T12(?1), T21(?1), T22(?1); and at a second incident angle, the first optical film has respective optical transmittances T11(?2) and T12(?2), and the second optical film has respective optical transmittances T21(?2) and T22(?2), wherein T21(?2)>T11(?2), T12(?2), T22(?2).

Abstract: The present disclosure is directed to self-contained biological indicators wherein a single type of indicator is capable of being used for various sterilization conditions, including sterilization with steam, hydrogen peroxide, and/or ethylene oxide. In some embodiments, a single type of biological indicator is capable of being used for different steam sterilization conditions having varied temperatures and sterilization cycles.

Abstract: A self-contained biological sterilization indicator comprises: a housing; bacterial spores comprising, and/or capable of producing, an enzyme capable of catalyzing cleavage of an enzyme substrate; and a frangible container containing a composition, wherein the composition comprises the enzyme substrate, wherein if the frangible container is broken the composition will contact the bacterial spores to form a mixture having an initial pH in the range from 6.0 to 9.0. The enzyme substrate comprises a fluorinated 4?-alkylumbelliferyl ?-D-glucopyranoside represented by the structural formula (I), wherein R is an alkyl group having from 1 to 12 carbon atoms. A biological sterilization indicator comprising a kit containing isolated components comprising (i) bacterial spores comprising, and/or capable of producing, an enzyme capable of catalyzing cleavage of the enzyme substrate and a method of assessing efficacy of a sterilization process are also disclosed.

Abstract: A method is provided. The method includes providing an article, the article including a nonwoven substrate having a copolymer grafted thereto, the copolymer including interpolymerized monomer units of a quaternary ammonium-containing ligand monomers; an amide monomer; an oxy monomer; and a coating on the nonwoven substrate, the coating including a plurality of test microorganisms, an enzyme or a second substrate; and contacting the article with a detection medium for a period of time.

Abstract: A microbial indicator device for liquid disinfection comprises a first cavity, a source of biological activity fluidically coupled to the first cavity via a portion of a first fluidic path, a filter membrane positioned in a second fluidic path for a disinfectant, and a first coupling portion fluidically coupled to the source of biologically activity via the second fluidic path. The filter membrane has a first side and a second side, wherein the first side is in fluid communication with the first fluidic path. The filter membrane has a pore size sufficient to retain at least a portion of the source of biological activity on the first side. The device further comprises a frangible container contained in the first cavity, wherein a liquid in the container is in fluid communication with the first cavity when the container is fractured.

Abstract: A method of verifying the efficacy of a disinfection process is provided. The method includes flowing a liquid disinfectant into an indicator device that has a plurality of indicator microorganisms disposed therein, the indicator microorganisms comprising or capable of producing a detectable enzyme activity; contacting the indicator microorganisms with the liquid disinfectant for a predetermined minimum first period of time at a first temperature; after contacting the indicator microorganisms with the liquid disinfectant for the first period of time at the first temperature, contacting the indicator microorganisms for a second period of time with a detection medium comprising a detection reagent; and during or after the second period of time, detecting a quantity of the detectable enzyme activity that was not inactivated by the contact with the disinfectant. The indicator device is also provided.

Abstract: A self-contained biological sterilization indicator comprises: a housing; bacterial spores comprising, and/or capable of producing, an enzyme capable of catalyzing cleavage of an enzyme substrate; and a frangible container containing a composition, wherein the composition comprises the enzyme substrate, wherein if the frangible container is broken the composition will contact the bacterial spores to form a mixture having an initial pH in the range from 6.0 to 9.0. The enzyme substrate comprises a fluorinated 4?-alkylumbelliferyl ?-D-glucopyranoside represented by the structural formula (I) wherein one of R1 and R2 is F and the other is H, and R3 is an alkyl group having from 1 to 12 carbon atoms. A biological sterilization indicator comprising a kit containing isolated components comprising (i) bacterial spores comprising, and/or capable of producing, an enzyme capable of catalyzing cleavage of the enzyme substrate and a method of assessing efficacy of a sterilization process are also disclosed.

Abstract: The present disclosure is directed to self-contained biological indicators wherein a single type of indicator is capable of being used for various sterilization conditions, including sterilization with steam and/or ethylene oxide. In some embodiments, a single type of biological indicator is capable of being used for different steam sterilization conditions having varied temperatures and sterilization cycles.