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- Nachgewiesen in: USPTO Patent Applications
- Sprachen: English
- Document Number: 20140160464
- Publication Date: June 12, 2014
- Appl. No: 13/965773
- Application Filed: August 13, 2013
- Assignees: Beckman Coulter, Inc. (Brea, CA, US)
- Claim: 1. An automated system for predicting a Mycobacterium tuberculosis infection status in an individual based on a biological sample obtained from blood of the individual, the system comprising: (a) an optical element having a cell interrogation zone; (b) a flow path configured to deliver a hydrodynamically focused stream of the biological sample toward the cell interrogation zone; (c) an electrode assembly configured to measure direct current (DC) impedance and radiofrequency (RF) conductivity of cells of the biological sample passing individually through the cell interrogation zone; (d) a light source oriented to direct a light beam along a beam axis to irradiate the cells of the biological sample individually passing through the cell interrogation zone; and (e) a light detection assembly optically coupled to the cell interrogation zone so as to measure light scattered by and transmitted through the irradiated cells of the biological sample, the light detection assembly configured to measure: (i) a first propagated light from the irradiated cells within a first range of angles relative to the light beam axis; (ii) a second propagated light from the irradiated cells within a second range of angles relative to the light beam axis, the second range being different than the first range; and (iii) an axial light propagated from the irradiated cells along the beam axis; (f) wherein the system is configured to correlate a subset of DC impedance, RF conductivity, the first propagated light, the second propagated light, and the axial light measurements from the cells of the biological sample with a prediction of Mycobacterium tuberculosis infection status in the individual.
- Claim: 2. The system according to claim 1, wherein the light detection assembly comprises a first sensor zone that measures the first propagated light, a second sensor zone that measures the second propagated light, and a third sensor zone that measures the axial propagated light.
- Claim: 3. The system according to claim 1, wherein the light detection assembly comprises a first sensor that measures the first propagated light, a second sensor that measures the second propagated light, and a third sensor that measures the axial propagated light.
- Claim: 4. The system according to claim 1, wherein the subset comprises DC impedance measurements for neutrophils, lymphocytes, monocytes, eosinophils, and non-nucleated red blood cells of the biological sample; or RF conductivity measurements for neutrophils, lymphocytes, eosinophils, and non-nucleated red blood cells of the biological sample.
- Claim: 5. The system according to claim 1, wherein a subset of Complete Blood Cell Count measurements from the cells of the biological sample combined with the subset of DC impedance, RF conductivity, the first propagated light, the second propagated light, and the axial light measurements are correlated with the prediction of Mycobacterium tuberculosis infection status in the individual.
- Claim: 6. The system according to claim 1, wherein the individual has a White Blood Cell Count of less than or equal to 6,000 per microliter of blood, and wherein the subset comprises a calculated parameter based on a function of at least two parameters selected from the group consisting of a high frequency current measurement of the sample, an axial light loss measurement of the sample, an upper median angle light scatter measurement of the sample, a low frequency current measurement of the sample, a low angle light scatter measurement of the sample, a lower median angle light scatter measurement of the sample, and a median angle light scatter measurement of the sample.
- Claim: 7. The system according to claim 1, wherein the individual has a White Blood Cell Count of greater than 6,000 per microliter of blood, and wherein the subset comprises a calculated parameter based on a function of at least two parameters selected from the group consisting of a high frequency current measurement of the sample, an axial light loss measurement of the sample, an upper median angle light scatter measurement of the sample, a low frequency current measurement of the sample, a low angle light scatter measurement of the sample, a lower median angle light scatter measurement of the sample, and a median angle light scatter measurement of the sample.
- Claim: 8. The system according to claim 1, wherein the individual has a White Blood Cell Count of less than or equal to 6,000 per microliter of blood, and wherein the subset includes a neutrophil calculated parameter comprising a member selected from the group consisting of: a ratio of a neutrophil high frequency current measurement to a neutrophil axial light loss measurement, a ratio of a neutrophil upper median angle light scatter measurement to a neutrophil low frequency current measurement, a ratio of a neutrophil low angle light scatter measurement to a neutrophil low frequency current measurement, and a ratio of a neutrophil high frequency current measurement to a neutrophil low frequency current measurement.
- Claim: 9. The system according to claim 1, wherein the individual has a White Blood Cell Count greater than 6,000 per microliter of blood, and wherein the subset includes a neutrophil calculated parameter comprising a member selected from the group consisting of: a ratio of a neutrophil upper median angle light scatter measurement to a neutrophil axial light loss measurement, a ratio of a neutrophil median angle light scatter measurement to a neutrophil axial light loss measurement, a ratio of a neutrophil low angle light scatter measurement to a neutrophil axial light loss measurement, a ratio of a neutrophil high frequency current measurement to a neutrophil axial light loss measurement, a ratio of a neutrophil low angle light scatter measurement to a neutrophil low frequency current measurement, a ratio of a neutrophil high frequency current measurement to a neutrophil low frequency current measurement, and a ratio of a neutrophil upper median angle light scatter measurement to a neutrophil median angle light scatter measurement.
- Claim: 10. The system according to claim 1, wherein the biological sample comprises: a blood sample of the individual; or neutrophils, lymphocytes, monocytes, eosinophils, and non-nucleated red blood cells of the individual.
- Claim: 11. The system according to claim 1, wherein the subset is determined based on a pre-defined specificity and/or sensitivity for tuberculosis.
- Claim: 12. The system according to claim 1, wherein the subset comprises a calculated parameter for identifying tuberculosis.
- Claim: 13. A method for predicting a Mycobacterium tuberculosis infection status in an individual based on a biological sample obtained from blood of the individual, the method comprising: (a) delivering a hydrodynamically focused stream of the biological sample toward a cell interrogation zone of an optical element; (b) measuring, with an electrode assembly, current (DC) impedance and radiofrequency (RF) conductivity of cells of the biological sample passing individually through the cell interrogation zone; (c) irradiating, with a light beam having an axis, cells of the biological sample individually passing through the cell interrogation zone; (d) measuring, with a light detection assembly, a first propagated light from the irradiated cells within a first range of angles relative to the beam axis; (e) measuring, with the light detection assembly, a second propagated light from the irradiated cells within a second range of angles relative to the beam axis, the second range being different than the first range; (f) measuring, with the light detection assembly, axial light propagated from the irradiated cells along the beam axis; and (g) correlating a subset of DC impedance, RF conductivity, the first propagated light, the second propagated light, and the axial light measurements from the cells of the biological sample with a predicted Mycobacterium tuberculosis infection status of the individual.
- Claim: 14. The method according to claim 13, wherein the light detection assembly comprises a first sensor zone that measures the first propagated light, a second sensor zone that measures the second propagated light, and a third sensor zone that measures the axial propagated light.
- Claim: 15. The method according to claim 13, wherein the light detection assembly comprises a first sensor that measures the first propagated light, a second sensor that measures the second propagated light, and a third sensor that measures the axial propagated light.
- Claim: 16. The method according to claim 13, wherein the subset comprises DC impedance measurements for neutrophils, lymphocytes, monocytes, eosinophils, and non-nucleated red blood cells of the biological sample; or RF conductivity measurements for neutrophils, lymphocytes, eosinophils, and non-nucleated red blood cells of the biological sample.
- Claim: 17. The method according to claim 13, wherein a subset of Complete Blood Cell Count measurements from the cells of the biological sample combined with the subset of DC impedance, RF conductivity, the first propagated light, the second propagated light, and the axial light measurements are correlated with the prediction of Mycobacterium tuberculosis infection status in the individual.
- Claim: 18. The method according to claim 13, wherein the individual has a White Blood Cell Count of less than or equal to 6,000 per microliter of blood, and wherein the subset comprises a calculated parameter based on a function of at least two parameters selected from the group consisting of a high frequency current measurement of the sample, an axial light loss measurement of the sample, an upper median angle light scatter measurement of the sample, a low frequency current measurement of the sample, a low angle light scatter measurement of the sample, a lower median angle light scatter measurement of the sample, and a median angle light scatter measurement of the sample.
- Claim: 19. The method according to claim 13, wherein the individual has a White Blood Cell Count of greater than 6,000 per microliter of blood, and wherein the subset comprises a calculated parameter based on a function of at least two parameters selected from the group consisting of a high frequency current measurement of the sample, an axial light loss measurement of the sample, an upper median angle light scatter measurement of the sample, a low frequency current measurement of the sample, a low angle light scatter measurement of the sample, a lower median angle light scatter measurement of the sample, and a median angle light scatter measurement of the sample.
- Claim: 20. The method according to claim 13, wherein the individual has a White Blood Cell Count of less than or equal to 6,000 per microliter of blood, and wherein the subset includes a neutrophil calculated parameter comprising a member selected from the group consisting of: a ratio of a neutrophil high frequency current measurement to a neutrophil axial light loss measurement, a ratio of a neutrophil upper median angle light scatter measurement to a neutrophil low frequency current measurement, a ratio of a neutrophil low angle light scatter measurement to a neutrophil low frequency current measurement, and a ratio of a neutrophil high frequency current measurement to a neutrophil low frequency current measurement.
- Claim: 21. The method according to claim 13, wherein the individual has a White Blood Cell Count greater than 6,000 per microliter of blood, and wherein the subset includes a neutrophil calculated parameter comprising a member selected from the group consisting of: a ratio of a neutrophil upper median angle light scatter measurement to a neutrophil axial light loss measurement, a ratio of a neutrophil median angle light scatter measurement to a neutrophil axial light loss measurement, a ratio of a neutrophil low angle light scatter measurement to a neutrophil axial light loss measurement, a ratio of a neutrophil high frequency current measurement to a neutrophil axial light loss measurement, a ratio of a neutrophil low angle light scatter measurement to a neutrophil low frequency current measurement, a ratio of a neutrophil high frequency current measurement to a neutrophil low frequency current measurement, and a ratio of a neutrophil upper median angle light scatter measurement to a neutrophil median angle light scatter measurement.
- Claim: 22. The method according to claim 13, wherein the biological sample comprises: a blood sample of the individual; or neutrophils, lymphocytes, monocytes, eosinophils, and non-nucleated red blood cells of the individual.
- Claim: 23. The method according to claim 13, wherein the subset is determined based on a pre-defined specificity and/or sensitivity for tuberculosis.
- Claim: 24. The method according to claim 13, wherein the subset comprises a calculated parameter for identifying tuberculosis.
- Claim: 25. An automated method of evaluating a biological sample from an individual, the method comprising: obtaining, using a particle analysis system, light scatter data, light absorption data, and current data for the biological sample as the sample passes through an aperture; determining a cell population data profile for the biological sample based on assay results obtained from the particle analysis system; determining, using a computer system, a predicted Mycobacterium tuberculosis infection status for the individual according to a calculated parameter, wherein the calculated parameter is based on a function of at least two cell population data measures of the cell population data profile; and outputting the predicted Mycobacterium tuberculosis infection status.
- Claim: 26. An automated system for predicting a Mycobacterium tuberculosis infection status of an individual, the system comprising: (a) a processor; and (b) a storage medium comprising a computer application that, when executed by the processor, is configured to cause the system to: (i) access cell population data concerning a biological sample of the individual; (ii) use the cell population data to determine a predicted Mycobacterium tuberculosis infection status of the individual; and (iii) output from the processor information relating to the predicted Mycobacterium tuberculosis infection status.
- Claim: 27. The system according to claim 26, wherein the processor is configured to receive the cell population data as input.
- Claim: 28. The system according to claim 26, wherein the processor, the storage medium, or both, are incorporated within a hematology machine.
- Claim: 29. The system according to claim 28, wherein the hematology machine generates the cell population data.
- Claim: 30. The system according to claim 26, wherein the processor, the storage medium, or both, are incorporated within a computer, and wherein the computer is in communication with a hematology machine.
- Claim: 31. The system according to claim 30, wherein the hematology machine generates the cell population data.
- Claim: 32. The system according to claim 26, wherein the processor, the storage medium, or both, are incorporated within a computer, and wherein the computer is in remote communication with a hematology machine via a network.
- Claim: 33. The system according to claim 32, wherein the hematology machine generates the cell population data.
- Claim: 34. The system according to claim 26, wherein the cell population data comprises a member selected from the group consisting of an axial light loss measurement of the sample, a light scatter measurement of the sample, and a current measurement of the biological sample.
- Claim: 35. An automated method for predicting a Mycobacterium tuberculosis infection status of an individual, the method comprising: (a) accessing cell population data concerning a biological sample of the individual by executing, with a processor, a storage medium comprising a computer application; (b) using the cell population data to determine a predicted Mycobacterium tuberculosis infection status of the individual by executing, with the processor, the storage medium; and (c) outputting from the processor information relating to the predicted Mycobacterium tuberculosis infection status.
- Claim: 36. The method according to claim 35, wherein the processor is configured to receive the cell population data as input.
- Claim: 37. The method according to claim 35, wherein the processor, the storage medium, or both, are incorporated within a hematology machine.
- Claim: 38. The system according to claim 37, wherein the hematology machine generates the cell population data.
- Claim: 39. The method according to claim 35, wherein the processor, the storage medium, or both, are incorporated within a computer, and wherein the computer is in communication with a hematology machine.
- Claim: 40. The system according to claim 39, wherein the hematology machine generates the cell population data.
- Claim: 41. The method according to claim 35, wherein the processor, the storage medium, or both, are incorporated within a computer, and wherein the computer is in remote communication with a hematology machine via a network.
- Claim: 42. The system according to claim 41, wherein the hematology machine generates the cell population data.
- Claim: 43. The method according to claim 35, wherein the cell population data comprises a member selected from the group consisting of an axial light loss measurement of the sample, a light scatter measurement of the sample, and a current measurement of the biological sample.
- Current U.S. Class: 356/39
- Current International Class: 01
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