Abstract: An apparatus and associated methods of use for a controlled combination of reagents is disclosed. The apparatus includes a vessel 400, a vessel insert 220, and a cap element 200. The vessel 400 has a body portion 410 for receiving a biological sample. The vessel insert 220 receives at least one reagent therein. Preferably, the vessel insert 220 is received in a portion 420 of the vessel 400. The cap element 200 is attached to the vessel 400 to secure the vessel insert 220 in the vessel 400. During use, the vessel insert 220 is adapted to release its contents when the biological sample is introduced into the body portion 410 of the vessel 400 upon application of an intermixing force to the vessel insert 220. A variety of intermixing forces may be applied, depending upon the embodiment of the present invention and its associated methods of use.

Abstract: Systems, methods, and apparatus for determining whether a culture in a vessel contains a plurality of microorganisms are provided. A normalization relative value is calculated for each respective measurement of a biological state of the culture between (i) the respective measurement and (ii) an initial biological state. For each fixed interval of time points, a derivative of the normalization relative values in the interval of time points is calculated, thereby forming a plurality of rate transformation values. For each set of rate transformation values in the plurality of rate transformation values, a measure of central tendency of the values in the set is computed, thereby forming a plurality of average relative transformation values. A determination whether the culture contains the microorganisms is made based on whether any calculated average relative transformation value exceeds a first threshold or whether an extent of growth exhibited by the culture exceeds a second threshold.

Abstract: Various embodiments disclosed herein provide for reagents and methods for rapidly isolating viable microbial cells, including S. pneumoniae, from positive blood culture samples. The resulting microbial pellet can be used for both identification and growth-based methods such as antimicrobial susceptibility testing. The buffers described herein may contain a base solution, non-ionic detergents, thiols, and optionally, ammonium chloride. The disclosed methods provide a process for rapidly isolating and concentrating viable microorganism(s) from PBC samples using only one sample preparation tube and centrifugation while removing cellular debris from the mammalian blood cells that may interfere with identification methods.

Abstract: A system and method with increased sensitivity to microorganism growth. The system includes signal processing electronic circuit connected to a consumable or vessel through two or more electrodes that fully penetrate the vessel and are in contact with the fluid contents. The electronic circuit is configured to detect a component of the total impedance of the sample, specifically the “out-of-phase” or imaginary reactance component, which has a sensitive response to organism growth in a frequency-dependent manner. The system detects changes in both the composition of charged molecules in the liquid matrix and the number of microorganisms based on monitoring the sample for change in this parameter. This results in a 5-70% reduction in time-to-detection (TTD). The system and method detect organisms in a plurality of vessel shapes, volumes, and matrix (or media) formats. The electrodes are fully immersed in a continuous body of liquid sample.

Abstract: An apparatus and associated methods of use for a controlled combination of reagents is disclosed. The apparatus includes a vessel 400, a vessel insert 220, and a cap element 200. The vessel 400 has a body portion 410 for receiving a biological sample. The vessel insert 220 receives at least one reagent therein. Preferably, the vessel insert 220 is received in a portion 420 of the vessel 400. The cap element 200 is attached to the vessel 400 to secure the vessel insert 220 in the vessel 400. During use, the vessel insert 220 is adapted to release its contents when the biological sample is introduced into the body portion 410 of the vessel 400 upon application of an intermixing force to the vessel insert 220. A variety of intermixing forces may be applied, depending upon the embodiment of the present invention and its associated methods of use.

Abstract: A system and method with increased sensitivity to microorganism growth. The system includes signal processing electronic circuit connected to a consumable or vessel through two or more electrodes that fully penetrate the vessel and are in contact with the fluid contents. The electronic circuit is configured to detect a component of the total impedance of the sample, specifically the “out-of-phase” or imaginary reactance component, which has a sensitive response to organism growth in a frequency-dependent manner. The system detects changes in both the composition of charged molecules in the liquid matrix and the number of microorganisms based on monitoring the sample for change in this parameter. This results in a 5-70% reduction in time-to-detection (TTD). The system and method detect organisms in a plurality of vessel shapes, volumes, and matrix (or media) formats. The electrodes are fully immersed in a continuous body of liquid sample.

Abstract: An apparatus and associated methods of use for a controlled combination of reagents is disclosed. The apparatus includes a vessel 400, a vessel insert 220, and a cap element 200. The vessel 400 has a body portion 410 for receiving a biological sample. The vessel insert 220 receives at least one reagent therein. Preferably, the vessel insert 220 is received in a portion 420 of the vessel 400. The cap element 200 is attached to the vessel 400 to secure the vessel insert 220 in the vessel 400. During use, the vessel insert 220 is adapted to release its contents when the biological sample is introduced into the body portion 410 of the vessel 400 upon application of an intermixing force to the vessel insert 220. A variety of intermixing forces may be applied, depending upon the embodiment of the present invention and its associated methods of use.

Abstract: Various embodiments disclosed herein provide for reagents and methods for rapidly isolating viable microbial cells, including S. pneumoniae, from positive blood culture samples. The resulting microbial pellet can be used for both identification and growth-based methods such as antimicrobial susceptibility testing. The buffers described herein may contain a base solution, non-ionic detergents, thiols, and optionally, ammonium chloride. The disclosed methods provide a process for rapidly isolating and concentrating viable microorganism(s) from PBC samples using only one sample preparation tube and centrifugation while removing cellular debris from the mammalian blood cells that may interfere with identification methods.

Abstract: Various embodiments disclosed herein provide for reagents and methods for rapidly isolating viable microbial cells, including S. pneumoniae, from positive blood culture samples. The resulting microbial pellet can be used for both identification and growth-based methods such as antimicrobial susceptibility testing. The buffers described herein may contain a base solution, non-ionic detergents, thiols, and optionally, ammonium chloride. The disclosed methods provide a process for rapidly isolating and concentrating viable microorganism (s) from PBC samples using only one sample preparation tube and centrifugation while removing cellular debris from the mammalian blood cells that may interfere with identification methods.

Abstract: Systems, methods and apparatus for determining an amount of blood in a blood culture are provided where an initial biological state and then periodic measurements of the biological state of the culture are taken. For each respective measurement, a normalization relative value between the respective measurement and the initial measurement is made thereby forming normalization relative values. For each interval of time points represented by the normalization relative values, a first derivative of the normalization relative values in the interval is made thereby forming a plurality of rate transformation values. For each set of rate transformation values in the plurality of rate transformation values, an average relative transformation value is computed, thereby forming average relative transformation values. A lookup table that matches a measure of central tendency of the average relative transformation values to a blood amount is used to determine the amount of blood in the culture.

Abstract: Systems, methods, and apparatus for determining whether a culture in a vessel contains a plurality of microorganisms are provided. A normalization relative value is calculated for each respective measurement of a biological state of the culture between (i) the respective measurement and (ii) an initial biological state. For each fixed interval of time points, a derivative of the normalization relative values in the interval of time points is calculated, thereby forming a plurality of rate transformation values. For each set of rate transformation values in the plurality of rate transformation values, a measure of central tendency of the values in the set is computed, thereby forming a plurality of average relative transformation values. A determination whether the culture contains the microorganisms is made based on whether any calculated average relative transformation value exceeds a first threshold or whether an extent of growth exhibited by the culture exceeds a second threshold.

Abstract: Systems, methods, and apparatus for determining whether a culture in a vessel contains a plurality of microorganisms are provided. A normalization relative value is calculated for each respective measurement of a biological state of the culture between (i) the respective measurement and (ii) an initial biological state. For each fixed interval of time points, a derivative of the normalization relative values in the interval of time points is calculated, thereby forming a plurality of rate transformation values. For each set of rate transformation values in the plurality of rate transformation values, a measure of central tendency of the values in the set is computed, thereby forming a plurality of average relative transformation values. A determination whether the culture contains the microorganisms is made based on whether any calculated average relative transformation value exceeds a first threshold or whether an extent of growth exhibited by the culture exceeds a second threshold.

Abstract: A system and method with increased sensitivity to microorganism growth. The system includes signal processing electronic circuit connected to a consumable or vessel through two or more electrodes that fully penetrate the vessel and are in contact with the fluid contents. The electronic circuit is configured to detect a component of the total impedance of the sample, specifically the “out-of-phase” or imaginary reactance component, which has a sensitive response to organism growth in a frequency-dependent manner. The system detects changes in both the composition of charged molecules in the liquid matrix and the number of microorganisms based on monitoring the sample for change in this parameter. This results in a 5-70% reduction in time-to-detection (TTD). The system and method detect organisms in a plurality of vessel shapes, volumes, and matrix (or media) formats. The electrodes are fully immersed in a continuous body of liquid sample.

Abstract: An apparatus and associated methods of use for a controlled combination of reagents is disclosed. The apparatus includes a vessel 400, a vessel insert 220, and a cap element 200. The vessel 400 has a body portion 410 for receiving a biological sample. The vessel insert 220 receives at least one reagent therein. Preferably, the vessel insert 220 is received in a portion 420 of the vessel 400. The cap element 200 is attached to the vessel 400 to secure the vessel insert 220 in the vessel 400. During use, the vessel insert 220 is adapted to release its contents when the biological sample is introduced into the body portion 410 of the vessel 400 upon application of an intermixing force to the vessel insert 220. A variety of intermixing forces may be applied, depending upon the embodiment of the present invention and its associated methods of use.

Abstract: Various embodiments disclosed herein provide for reagents and methods for rapidly isolating viable microbial cells, including S. pneumoniae, from positive blood culture samples. The resulting microbial pellet can be used for both identification and growth-based methods such as antimicrobial susceptibility testing. The buffers described herein may contain a base solution, non-ionic detergents, thiols, and optionally, ammonium chloride. The disclosed methods provide a process for rapidly isolating and concentrating viable microorganism (s) from PBC samples using only one sample preparation tube and centrifugation while removing cellular debris from the mammalian blood cells that may interfere with identification methods.

Abstract: Systems, methods and apparatus for identifying a microorganism type in a culture are provided. A normalization relative value is calculated for each respective measurement of a biological state of the culture between (i) the respective measurement and (ii) an initial biological state. For each fixed interval of time points, a first derivative of the normalization relative values in the interval of time points is calculated, thereby forming a plurality of rate transformation values. For each respective set of rate transformation values in the plurality of rate transformation values, a measure of central tendency of the rate transformation values in the set is computed, thereby forming a plurality of average relative transformation values. A maximum metabolic rate and an extent of growth, determined from the normalization relative values and the average relative transformation values, are compared against a lookup table that matches these values to a microorganism type.

Abstract: Systems, methods and apparatus for determining an amount of blood in a blood culture are provided where an initial biological state and then periodic measurements of the biological state of the culture are taken. For each respective measurement, a normalization relative value between the respective measurement and the initial measurement is made thereby forming normalization relative values. For each interval of time points represented by the normalization relative values, a first derivative of the normalization relative values in the interval is made thereby forming a plurality of rate transformation values. For each set of rate transformation values in the plurality of rate transformation values, an average relative transformation value is computed, thereby forming average relative transformation values. A lookup table that matches a measure of central tendency of the average relative transformation values to a blood amount is used to determine the amount of blood in the culture.

Abstract: Systems, methods, and apparatus for determining whether a culture in a vessel contains a plurality of microorganisms are provided. A normalization relative value is calculated for each respective measurement of a biological state of the culture between (i) the respective measurement and (ii) an initial biological state. For each fixed interval of time points, a derivative of the normalization relative values in the interval of time points is calculated, thereby forming a plurality of rate transformation values. For each set of rate transformation values in the plurality of rate transformation values, a measure of central tendency of the values in the set is computed, thereby forming a plurality of average relative transformation values. A determination whether the culture contains the microorganisms is made based on whether any calculated average relative transformation value exceeds a first threshold or whether an extent of growth exhibited by the culture exceeds a second threshold.

Abstract: The present invention relates to methods for detection and evaluation of metabolic activity of eukaryotic and/or prokaryotic cells based upon their ability to consume dissolved oxygen. The methods utilize a luminescence detection system which makes use of the sensitivity of the luminescent emission of certain compounds to the presence of oxygen, which quenches (diminishes) the compound's luminescent emission in a concentration dependent manner. Respiring eukaryotic and/or prokaryotic cells will affect the oxygen concentration of a liquid medium in which they are immersed. Thus, this invention provides a convenient system to gather information on the presence, identification, quantification and cytotoxic activity of eukaryotic and/or prokaryotic cells by determining their effect on the oxygen concentration of the media in which they are present.

Abstract: The present invention relates to methods for detection and evaluation of metabolic activity of eukaryotic and/or prokaryotic cells based upon their ability to consume dissolved oxygen. The methods utilize a luminescence detection system which makes use of the sensitivity of the luminescent emission of certain compounds to the presence of oxygen, which quenches (diminishes) the compound's luminescent emission in a concentration dependent manner. Respiring eukaryotic and/or prokaryotic cells will affect the oxygen concentration of a liquid medium in which they are immersed. Thus, this invention provides a convenient system to gather information on the presence, identification, quantification and cytotoxic activity of eukaryotic and/or prokaryotic cells by determining their effect on the oxygen concentration of the media in which they are present.