Abstract: A clinical sample testing system includes a portable apparatus for transport and incubation of a clinical sample in a culture vessel. The apparatus includes a sealable container having a thermally insulated compartment for receiving the vessel and a heater for heating the clinical sample to a temperature suitable for pre-culturing it. The system further includes a microorganism detection device which receives the vessel and cultures the clinical sample. The device includes a) a test aliquot extraction device for removing a test aliquot from the vessel and/or from a second culture vessel sampled therefrom, and a DNA testing device for separating DNA from the test aliquot and performing nucleic acid tests on the DNA to identify the microorganism and detecting genetic antimicrobial resistance markers therein and/or b) an antimicrobial susceptibility test device for performing an antimicrobial susceptibility test on the cultured clinical sample or portion thereof by monitoring microbial growth.

Abstract: A portable apparatus and method for transport and incubation of a medical sample in a blood culture flask includes a sealable container having a thermally insulated compartment for receiving the blood culture flask and a heater for heating the medical sample to a temperature suitable for pre-culturing of the sample. An agitator is provided for agitating the sample in the blood culture flask.

Abstract: The present invention relates to a method of determining the concentration of intact microorganisms in a sample comprising optionally diluting an aliquot of the sample to provide a diluted aliquot at a dilution value; contacting at least a portion of an aliquot or of a diluted aliquot of the sample with first and second stains capable of binding to DNA, wherein the first stain is a fluorescent stain, is cell-permeable, and has a first emission wavelength, and the second stain is cell-impermeable, and is capable of acting as an acceptor molecule in a FRET pair with the first stain acting as a donor molecule; imaging the aliquot-stain mixture at the first emission wavelength and determining an image analysis value for the number of objects corresponding to intact microorganisms in the imaged mixture; and comparing the image analysis value for said aliquot to a pre-determined calibration curve, as well as an apparatus, a consumable and a kit therefor.

Abstract: The present invention provides methods for determining the antimicrobial susceptibility of a microorganism in a clinical sample said method comprising removing a test aliquot from a clinical sample culture before the culture reaches 0.5 McFarland units, isolating the microbial cells and transferring the cells into a suitable culture medium for microbial growth, and performing an AST assay using the isolated microbes, wherein the concentration of microbial cells in the microbial cells used to set up the AST assay is measured before the degree of microbial growth in the different growth conditions of the AST assay is measured. Devices for determining the antimicrobial susceptibility of a microorganism in a clinical sample are also provided.

Abstract: A clinical sample testing system includes a portable apparatus for transport and incubation of a clinical sample in a culture vessel. The apparatus includes a sealable container having a thermally insulated compartment for receiving the vessel and a heater for heating the clinical sample to a temperature suitable for pre-culturing it. The system further includes a microorganism detection device which receives the vessel and cultures the clinical sample. The device includes a) a test aliquot extraction device for removing a test aliquot from the vessel and/or from a second culture vessel sampled therefrom, and a DNA testing device for separating DNA from the test aliquot and performing nucleic acid tests on the DNA to identify the microorganism and detecting genetic antimicrobial resistance markers therein and/or b) an antimicrobial susceptibility test device for performing an antimicrobial susceptibility test on the cultured clinical sample or portion thereof by monitoring microbial growth.

Abstract: An apparatus is for moving a sample holder on a platform from a loading position where the sample holder can be removed from the platform to a locked position where the sample holder is securely held. The sample holder is configured to rest on wheels within a recessed portion on the platform. The apparatus is configured such that: (i) movement of the platform from the loading position to the locked position causes a vertical clamp to lower down on top of the sample holder, and a horizontal clamp to be pressed to an outer periphery of the sample holder; and (ii) movement of the platform from the locked position to the loading position causes the vertical clamp to rise above the sample holder, and the horizontal clamp to be moved away from the outer periphery of the sample holder.

Abstract: A method for detecting and characterising a microorganism in a clinical sample includes introducing the clinical sample to a first culture vessel and simultaneously transporting and incubating the clinical sample in a thermally insulated compartment of a sealable container. A test aliquot is removed from the sample and the remainder of the sample is further cultured. DNA is removed from the test aliquot and nucleic acid tests are performed on it to identify the microorganism and to detect the presence or absence of one or more genetic antimicrobial resistance markers in the microorganism. One or more nucleic acid probes or primers are used to perform the nucleic acid tests. It is detected whether or not the probes or primers have hybridised to DNA or the primers have been extended. If a microorganism is identified, then an antimicrobial susceptibility test is performed on the cultured clinical sample.

Abstract: A method for detecting and characterizing a microorganism in a clinical sample includes introducing a clinical sample to a first culture vessel containing the culture medium; removing a test aliquot; separating DNA from the test aliquot; and performing nucleic acid tests on the DNA to identify the microorganism and to detect the presence or absence of one or more genetic antimicrobial resistance markers in the microorganism. If a microorganism is identified, an antimicrobial susceptibility test is performed wherein microbial growth in the antimicrobial susceptibility test is monitored by accessing growth or markers for growth and wherein the type and concentration of antimicrobial agents used in the antimicrobial susceptibility test is determined by the identity of the microorganism and the antimicrobial resistance markers detected. A device for performing the method is also provided.

Abstract: A method of image-based analysis of multiple samples includes using a sample holder having multiple locations of interest and multiple focal structures that are each associated, one or more, with the multiple locations of interest, wherein the multiple samples are dispersed across the multiple locations of interest and obtaining image areas of the multiple locations of interest. Multiple digital image areas are thus obtained for use in an analysis of the multiple samples with each of the image areas including at least one of the locations of interest and at least one of the focal structures. An image processing algorithm is used to analyse each of the digital image areas and check if the focal structure indicates that the image area is in clear focus. An indication is provided and/or remedial action is taken if the image processing algorithm indicates that any digital image areas are out of focus.

Abstract: A substrate for use in manufacture of a production master plate for production of a detection disc for carrying samples in an apparatus for detection of microscopic objects in a fluid, the substrate having a channel and separate focus structure, wherein the focus structure is a groove.

Abstract: A portable apparatus and method for transport and incubation of a medical sample in a blood culture flask includes a sealable container having a thermally insulated compartment for receiving the blood culture flask and a heater for heating the medical sample to a temperature suitable for pre-culturing of the sample. An agitator is provided for agitating the sample in the blood culture flask.

Abstract: A method of image-based analysis of multiple samples includes using a sample holder having multiple locations of interest and multiple focal structures that are each associated, one or more, with the multiple locations of interest, wherein the multiple samples are dispersed across the multiple locations of interest and obtaining image areas of the multiple locations of interest. Multiple digital image areas are thus obtained for use in an analysis of the multiple samples with each of the image areas including at least one of the locations of interest and at least one of the focal structures. An image processing algorithm is used to analyse each of the digital image areas and check if the focal structure indicates that the image area is in clear focus. An indication is provided and/or remedial action is taken if the image processing algorithm indicates that any digital image areas are out of focus.

Abstract: A portable apparatus for transport and incubation of a medical sample in a blood culture flask includes a sealable container having a thermally insulated compartment for receiving the blood culture flask and a heater for heating the medical sample to a temperature suitable for pre-culturing of the sample. An agitator is provided for agitating the sample in the blood culture flask.

Abstract: The present invention provides methods for determining the antimicrobial susceptibility of a microorganism in a clinical sample said method comprising removing a test aliquot from a clinical sample culture before the culture reaches 0.5 McFarland units, isolating the microbial cells and transferring the cells into a suitable culture medium for microbial growth, and performing an AST assay using the isolated microbes, wherein the concentration of microbial cells in the microbial cells used to set up the AST assay is measured before the degree of microbial growth in the different growth conditions of the AST assay is measured. Devices for determining the antimicrobial susceptibility of a microorganism in a clinical sample are also provided.

Abstract: A sample holder 100 for use in a device for image-based analysis of multiple samples, the sample holder comprising: an optically flat surface 10; multiple locations of interest 16, 18 dispersed across the optically flat surface 10 that each, in use, correspond to locations of a sample of the multiple samples; and multiple focal structures 12 associated with the multiple locations of interest 16, 18; wherein the focal structures 12 each comprise at least one pyramid shaped indentation 30 in the optically flat surface 10.

Abstract: A method for determining the antimicrobial susceptibility of a microorganism in a clinical sample includes removing a test aliquot from a clinical sample culture before the culture reaches 0.5 McFarland units and isolating the microbial cells. The cells are transferred into a suitable culture medium for microbial growth and an AST assay is performed using the isolated microbes. The concentration of microbial cells in the microbial cells used to set up the AST assay is measured before measuring the degree of microbial growth in different conditions of the AST assay. Devices for determining the anti-microbial susceptibility of a microorganism in a clinical sample are also disclosed.

Abstract: A method for detecting and characterizing a microorganism in a clinical sample includes introducing a clinical sample to a first culture vessel containing the culture medium; removing a test aliquot; separating DNA from the test aliquot; and performing nucleic acid tests on the DNA to identify the microorganism and to detect the presence or absence of one or more genetic antimicrobial resistance markers in the microorganism. If a microorganism is identified, an antimicrobial susceptibility test is performed wherein microbial growth in the antimicrobial susceptibility test is monitored by accessing growth or markers for growth and wherein the type and concentration of antimicrobial agents used in the antimicrobial susceptibility test is determined by the identity of the microorganism and the antimicrobial resistance markers detected. A device for performing the method is also provided.

Abstract: The present invention relates to a method of determining the concentration of intact microorganisms in a sample comprising optionally diluting an aliquot of the sample to provide a diluted aliquot at a dilution value; contacting at least a portion of an aliquot or of a diluted aliquot of the sample with first and second stains capable of binding to DNA, wherein the first stain is a fluorescent stain, is cell-permeable, and has a first emission wavelength, and the second stain is cell-impermeable, and is capable of acting as an acceptor molecule in a FRET pair with the first stain acting as a donor molecule; imaging the aliquot-stain mixture at the first emission wavelength and determining an image analysis value for the number of objects corresponding to intact microorganisms in the imaged mixture; and comparing the image analysis value for said aliquot to a pre-determined calibration curve, as well as an apparatus, a consumable and a kit therefor.

Abstract: A method for detecting and characterizing a microorganism in a clinical sample includes introducing a clinical sample to a first culture vessel containing the culture medium; removing a test aliquot; separating DNA from the test aliquot; and performing nucleic acid tests on the DNA to identify the microorganism and to detect the presence or absence of one or more genetic antimicrobial resistance markers in the microorganism. If a microorganism is identified, an antimicrobial susceptibility test is performed wherein microbial growth in the antimicrobial susceptibility test is monitored by accessing growth or markers for growth and wherein the type and concentration of antimicrobial agents used in the antimicrobial susceptibility test is determined by the identity of the microorganism and the antimicrobial resistance markers detected. A device for performing the method is also provided.