Abstract: The present invention is directed to methods and kits for separating, accumulating, characterizing and/or identifying microorganisms known to be present or that may be present in a test sample. The method of the invention comprises optional lysing non-microorganism cells and/or particulates that may be present in a test sample, followed by a subsequent filtration step for isolation and/or accumulation of microorganisms. The kit of the present invention may comprise at least one filter membrane or an integrated filtration and sample transfer device for isolation and/or accumulation of microorganisms.

Abstract: The present invention is directed to a separation device or container that can be used in the separation, isolation or pelleting of microorganisms from a test samples known to contain or suspected of containing said microorganisms. Subsequently, the separated, isolated or pelleted microorganism sample can undergo one or more interrogation steps to provide measurements useful for the characterization and/or identification of microorganism. In one aspect of the present invention, the interrogation steps can occur in situ in the separation device or container described herein.

Abstract: A method for identification and/or characterization of a microbial agent present in a sample includes a step of analytical test data (e.g., obtaining intrinsic fluorescence values over a range of emission wavelengths) from the microbial agent. The analytical test data is transformed thereby minimizing strain to strain variations within an organism group. With the aid of a programmed computer, a multi-level classification algorithm coded as a set of processing instructions operates on the transformed analytic test data. The multiple levels correspond to different levels in a taxonomic hierarchy for microbial agents suspected of being in the sample.

Abstract: The present invention provides a method and system for monitoring, detecting, and/or characterizing a biological particle that may be present in a sample. The method may be accomplished in a sealed container by utilizing a first step time-dependent spectroscopic technique to obtain at least two measurements of a growth composition comprising a sample and correlating said measurements for the detection and/or characterization of a biological particle that may be present in the sample. The method further provides for a subsequent step for the separation, characterizion and/or identification of the microorganisms in the sealed container.

Abstract: The present invention is directed to a method for separating, characterizing and/or identifying microorganisms in a test sample. The method of the invention comprises an optional lysis step for lysing non-microorganism cells that may be present in a test sample, followed by a subsequent separation step. The method may be useful for the separation, characterization and/or identification of microorganisms from complex samples such as blood-containing culture media. The invention further provides methods for separating, characterizing and/or identifying microorganisms in situ within a single system.

Abstract: A device and method for determining antimicrobial resistance status of a microorganism from a positive sample bottle is provided. The device may include a housing having a chamber for receiving a vial containing a sample; a light source positioned to direct light through a side of the chamber; and a photodetector positioned such that light transmitted or scattered by the sample is sensed by the photodetector. The device may also include a heat source and/or an agitation device. The method includes providing the device, loading a sample from an automated sample culture system into the vial; interrogating the vial using the light source and the photodetector; and determining the antimicrobial resistance status of the microorganism in the sample based on the interrogating step. The method may also include heating and/or agitating the sample.

Abstract: A detection instrument determines whether a specimen container (e.g., blood culture bottle) is positive for presence of microbial agent growth therein. When the container is deemed positive it is made available (e.g, transferred or exposed to) to an automated instrument performing identification and/or characterization of the microbial agent. The identification and/or characterization instrument removes a portion of the sample from the specimen container and places it into a disposable separation and concentration device. The microbial agent is concentrated via optional selective lysis of non-microbial agent cellular material which may be present and centrifugation. A reading module reads the concentrated microbial agent using spectroscopic methods, e.g., measurements of intrinsic fluorescence. Such interrogation may occur while the microbial agent remains concentrated in the disposable device.

Abstract: The present invention relates to methods and systems for scanning, detecting, and monitoring microorganisms on solid or semi-solid media using intrinsic fluorescence (IF) measurements. The methods are further directed to detection, characterization and/or identification of microorganisms on a solid or semi-solid media using intrinsic fluorescence (IF) measurements that are characteristic of said microorganisms.

Abstract: A sampling device for a specimen container having a closure sealing the interior of the specimen container from the environment includes a needle, a body coupled to the needle and defining a chamber in fluid communication with the needle, the body further comprising a port forming an opening in the body, the port in fluid communication with the chamber. A multitude of the sampling devices may be stored in a cassette. The sampling devices may include a second chamber for separation and concentration of a microbial agent present in a sample. In this configuration second chamber is connected to the first chamber via a valve or the like.

Abstract: A device and method for determining antimicrobial resistance status of a microorganism from a positive sample bottle is provided. The device may include a housing having a chamber for receiving a vial containing a sample; a light source positioned to direct light through a side of the chamber; and a photodetector positioned such that light transmitted or scattered by the sample is sensed by the photodetector. The device may also include a heat source and/or an agitation device. The method includes providing the device, loading a sample from an automated sample culture system into the vial; interrogating the vial using the light source and the photodetector; and determining the antimicrobial resistance status of the microorganism in the sample based on the interrogating step. The method may also include heating and/or agitating the sample.

Abstract: The present invention is directed to a separation device or container that can be used in the separation, isolation or pelleting of microorganisms from a test samples known to contain or suspected of containing said microorganisms. Subsequently, the separated, isolated or pelleted microorganism sample can undergo one or more interrogation steps to provide measurements useful for the characterization and/or identification of microorganism. In one aspect of the present invention, the interrogation steps can occur in situ in the separation device or container described herein.

Abstract: The present invention is directed to a method for separating, characterizing and/or identifying microorganisms in a test sample. The method of the invention comprises an optional lysis step for lysing non-microorganism cells that may be present in a test sample, followed by a subsequent separation step. The method may be useful for the separation, characterization and/or identification of microorganisms from complex samples such as blood-containing culture media. The invention further provides for the use of one or more identifier agents and interrogating the microorganism sample and/or said one or more identifier agents to produce measurements which characterizing and/or identifying the microorganism based on the produced measurements and/or the presence or absence of the identifier agent or a metabolized form of the identifier agent in the microorganism sample.

Abstract: A detection instrument determines whether a specimen container (e.g., blood culture bottle) is positive for presence of microbial agent growth therein. When the container is deemed positive it is made available (e.g, transferred or exposed to) to an automated instrument performing identification and/or characterization of the microbial agent. The identification and/or characterization instrument removes a portion of the sample from the specimen container and places it into a disposable separation and concentration device. The microbial agent is concentrated via optional selective lysis of non-microbial agent cellular material which may be present and centrifugation. A reading module reads the concentrated microbial agent using spectroscopic methods, e.g., measurements of intrinsic fluorescence. Such interrogation may occur while the microbial agent remains concentrated in the disposable device.

Abstract: An automated instrument for identification and/or characterization of a microbial agent present in a sample. The instrument includes (a) a sample removal apparatus operative to remove a test sample from a specimen container and add the test sample to a disposable separation device; (b) a separation and concentration apparatus operative on the separation device to separate the microbial agent from other components which may be present in the test sample and concentrate the microbial agent within the separation device; and (c) a identification and/or characterization module interrogating the concentrated microbial agent to identify and/or characterize the microbial agent.

Abstract: The present invention relates to methods and systems for scanning, detecting, and monitoring microorganisms on solid or semi-solid media using intrinsic fluorescence (IF) measurements. The methods are further directed to detection, characterization and/or identification of microorganisms on a solid or semi-solid media using intrinsic fluorescence (IF) measurements that are characteristic of said microorganisms.

Abstract: A detection instrument determines whether a specimen container (e.g., blood culture bottle) is positive for presence of microbial agent growth therein. When the container is deemed positive it is made available (e.g, transferred or exposed to) to an automated instrument performing identification and/or characterization of the microbial agent. The identification and/or characterization instrument removes a portion of the sample from the specimen container and places it into a disposable separation and concentration device. The microbial agent is concentrated via optional selective lysis of non-microbial agent cellular material which may be present and centrifugation. A reading module reads the concentrated microbial agent using spectroscopic methods, e.g., measurements of intrinsic fluorescence. Such interrogation may occur while the microbial agent remains concentrated in the disposable device.

Abstract: The present invention is directed to a method for inactivation and/or extraction of acid-fast bacteria (e.g., mycobacteria or nocardia), the method comprising the following sequential steps: (a) acquiring a test sample known to contain or that may contain acid-fast bacteria and suspending the test sample in a container containing ethanol and beads; (b) bead beating and/or vortexing the container to break up clumps and/or disrupt acid-fast bacteria cells in the container; and (c) subsequently incubating the suspension for at least about 3 minutes at room temperature to inactivate any acid-fast bacteria contained in the test sample. In accordance with the present invention, the test sample can subsequently be pelleted by centrifugation, resuspended with formic acid, acetonitrile added, and subjected to mass spectrometry for characterization and/or identification of the acid-fast bacteria.

Abstract: A method for identification and/or characterization of a microbial agent present in a sample includes a step of analytical test data (e.g., obtaining intrinsic fluorescence values over a range of emission wavelengths) from the microbial agent. The analytical test data is transformed thereby minimizing strain to strain variations within an organism group. With the aid of a programmed computer, a multi-level classification algorithm coded as a set of processing instructions operates on the transformed analytic test data.

Abstract: A method for identification and/or characterization of a microbial agent present in a sample includes a step of analytical test data (e.g., obtaining intrinsic fluorescence values over a range of emission wavelengths) from the microbial agent. The analytical test data is transformed thereby minimizing strain to strain variations within an organism group. With the aid of a programmed computer, a multi-level classification algorithm coded as a set of processing instructions operates on the transformed analytic test data. The multiple levels correspond to different levels in a taxonomic hierarchy for microbial agents suspected of being in the sample.

Abstract: The present invention is directed to a method for separating, characterizing and/or identifying microorganisms in a test sample. The method of the invention comprises an optional lysis step for lysing non-microorganism cells that may be present in a test sample, followed by a subsequent separation step. The method may be useful for the separation, characterization and/or identification of microorganisms from complex samples such as blood-containing culture media. The invention further provides for spectroscopic interrogation of the separated microorganism sample to produce measurements of the microorganism and characterizing and/or identifying the microorganism in the sample using said spectroscopic measurements.