| Sonstiges: |
- Nachgewiesen in: USPTO Patent Applications
- Sprachen: English
- Document Number: 20140172321
- Publication Date: June 19, 2014
- Appl. No: 13/965838
- Application Filed: August 13, 2013
- Assignees: Beckman Coulter, Inc. (Brea, CA, US)
- Claim: 1. An automated system for predicting an acute leukemia sub-type of an individual diagnosed with acute leukemia 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 an acute leukemic sub-type of 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: (i) DC impedance measurements for lymphocytes, monocytes, eosinophils, and non-nucleated red blood cells of the biological sample; (ii) RF conductivity, ALL, LALS, UMALS, and LMALS measurements for neutrophils of the biological sample; (iii) a neutrophil measurement, a monocyte measurement, an eosinophil measurement, a non-nucleated red blood cell measurement, or a combination of two or more thereof, and wherein the acute leukemic sub-type comprises acute lymphoblastic leukemia (ALL); (iv) a standard deviation high frequency current neutrophil measurement, a mean upper median angle light scatter neutrophil measurement, a standard deviation upper median angle light scatter neutrophil measurement, a standard deviation low angle light scatter neutrophil measurement, standard deviation axial light loss neutrophil measurement, a mean low frequency current lymphocyte measurement, a mean high frequency current lymphocyte measurement, a standard deviation high frequency current lymphocyte measurement, a mean low angle light scatter lymphocyte measurement, a mean axial light loss lymphocyte measurement, a mean low frequency current monocyte measurement, a standard deviation low frequency current monocyte measurement, a mean high frequency current monocyte measurement, a standard deviation high frequency current monocyte measurement, a mean lower median angle light scatter monocyte measurement, a mean low angle light scatter monocyte measurement, a mean axial light loss monocyte measurement, a mean low frequency current eosinophil measurement, a standard deviation low frequency eosinophil measurement, a mean lower median angle light scatter eosinophil measurement, a mean high frequency current non-nucleated red blood cell measurement, a standard deviation high frequency current non-nucleated red blood cell measurement, a standard deviation upper median angle light scatter non-nucleated red blood measurement, or a combination of two or more thereof; (v) a neutrophil calculated parameter, a monocyte calculated parameter, an eosinophil calculated parameter, a non-nucleated red blood cell calculated parameter, or a combination of two or more thereof, and wherein the acute leukemic sub-type comprises acute lymphoblastic leukemia (ALL); or (vi) a calculated parameter based on a function of at least two parameters selected from the group consisting of the axial light loss measurement of the sample, a low frequency current measurement of the sample, a high 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 an upper median angle light scatter measurement of the sample.
- Claim: 5. The system according to claim 1, wherein the subset comprises a calculated parameter based on a function of at least two neutrophil measurements.
- Claim: 6. The system according to claim 5, wherein: (i) the at least two neutrophil measurements are selected from the group consisting of a neutrophil upper median angle light scatter measurement, a neutrophil median angle light scatter measurement, and a neutrophil lower median angle light scatter measurement; or (ii) the calculated parameter is based on a ratio of a neutrophil upper median angle light scatter measurement to a neutrophil median angle light scatter measurement, the neutrophil median angle light scatter measurement comprising the sum of the neutrophil upper median angle light scatter measurement and a neutrophil lower median angle light scatter measurement.
- Claim: 7. The system according to claim 1, wherein the subset comprises a calculated parameter based on a function of at least two monocyte measurements.
- Claim: 8. The system according to claim 7, wherein: (i) the at least two monocyte measurements are selected from the group consisting of a monocyte high frequency current measurement, a monocyte low frequency current measurement, a monocyte axial light loss measurement, a monocyte median angle light scatter measurement, a monocyte low angle light scatter measurement, a monocyte upper median angle light scatter measurement, and a monocyte lower median angle light scatter measurement; or (ii) the calculated parameter comprises a member selected from the group consisting of: a ratio of a monocyte high frequency current measurement to a monocyte low frequency current measurement, a ratio of a monocyte low angle light scatter measurement to a monocyte axial light loss measurement, a ratio of a monocyte low frequency current measurement to a monocyte axial light loss measurement, a ratio of a monocyte upper median angle light scatter measurement to a monocyte low frequency current measurement, a ratio of a monocyte low angle light scatter measurement to a monocyte low frequency current measurement, a ratio of a monocyte low angle light scatter measurement to a monocyte median angle light scatter measurement, the monocyte median angle light scatter measurement comprising the sum of a monocyte upper median angle light scatter measurement and a monocyte lower median angle light scatter measurement, a ratio of a monocyte upper median angle light scatter measurement to a monocyte median angle light scatter measurement, the monocyte median angle light scatter measurement comprising the sum of the monocyte upper median angle light scatter measurement and a monocyte lower median angle light scatter measurement, and a ratio of a monocyte lower median angle light scatter measurement to a monocyte median angle light scatter measurement, the monocyte median angle light scatter measurement comprising the sum of a monocyte upper median angle light scatter measurement and the monocyte lower median angle light scatter measurement.
- Claim: 9. The system according to claim 1, wherein the subset comprises a calculated parameter based on a function of at least two eosinophil measurements.
- Claim: 10. The system according to claim 11, wherein: (i) the at least two eosinophil measurements are selected from the group consisting of an eosinophil lower median angle light scatter measurement, an eosinophil median angle light scatter measurement, and an eosinophil upper median angle light scatter measurement; or (ii) the calculated parameter comprises a ratio of an eosinophil lower median angle light scatter measurement to an eosinophil median angle light scatter measurement, the eosinophil median angle light scatter measurement comprising the sum of an eosinophil upper median angle light scatter measurement and the eosinophil lower median angle light scatter measurement.
- Claim: 11. The system according to claim 1, wherein the subset comprises a calculated parameter based on a function of at least two non-nucleated red blood cell measurements.
- Claim: 12. The system according to claim 11, wherein: (i) the at least two non-nucleated red blood cell measurements are selected from the group consisting of a non-nucleated red blood cell lower median angle light scatter measurement, a non-nucleated red blood cell axial light loss measurement, a non-nucleated red blood cell low angle light scatter measurement, a non-nucleated red blood cell median angle light scatter measurement, and a non-nucleated red blood cell upper median angle light scatter measurement; or (ii) the calculated parameter comprises a member selected from the group consisting of: a ratio of a non-nucleated red blood cell lower median angle light scatter measurement to a non-nucleated red blood cell axial light loss measurement, a ratio of a non-nucleated red blood cell low angle light scatter measurement to a non-nucleated red blood cell axial light loss measurement, and a ratio of a non-nucleated red blood cell lower median angle light scatter measurement to a non-nucleated red blood cell median angle light scatter measurement, the non-nucleated red blood cell median angle light scatter measurement comprising the sum of a non-nucleated red blood cell upper median angle light scatter measurement and the non-nucleated red blood cell lower median angle light scatter measurement.
- Claim: 13. The system according to claim 1, wherein the subset comprises: (a) a neutrophil measurement, a monocyte measurement, an eosinophil measurement, a non-nucleated red blood cell measurement, or a combination of two or more thereof, and wherein the acute leukemic sub-type comprises acute promyelocytic leukemia (APL); or (b) a mean low angle light scatter neutrophil measurement, a mean median angle light scatter neutrophil measurement, a mean low frequency current lymphocyte measurement, a mean low frequency current monocyte measurement, a mean lower median angle light scatter monocyte measurement, a standard deviation axial light loss monocyte measurement, a mean median angle light scatter eosinophil measurement, a mean low frequency current non-nucleated red blood cell measurement, a standard deviation median angle light scatter non-nucleated red blood cell measurement, or a combination of two or more thereof.
- Claim: 14. The system according to claim 1, wherein the subset comprises a neutrophil calculated parameter, a lymphocyte calculated parameter, an eosinophil calculated parameter, a non-nucleated red blood cell calculated parameter, or a combination of two or more thereof, and wherein the acute leukemic sub-type comprises acute promyelocytic leukemia (APL).
- Claim: 15. The system according to claim 14, wherein: (i) the neutrophil calculated parameter comprises a ratio of a neutrophil high frequency current measurement to a neutrophil axial light loss measurement; (ii) the lymphocyte calculated parameter comprises a ratio of a lymphocyte lower median angle light scatter measurement to a lymphocyte mean median angle light scatter measurement; (iii) the eosinophil calculated parameter comprises a ratio of an eosinophil lower median angle light scatter measurement to a eosinophil axial light loss measurement; or (iv) the non-nucleated red blood cell calculated parameter comprises a ratio of a non-nucleated red blood cell low angle light scatter measurement to a non-nucleated red blood cell low frequency current measurement.
- Claim: 16. The system according claim 1, wherein the biological sample comprises: (i) a blood sample of the individual; or (ii) neutrophils, lymphocytes, monocytes, eosinophils, and non-nucleated red blood cells of the individual.
- Claim: 17. The system according to claim 1, wherein the acute leukemic sub-type comprises a member selected from the group consisting of an acute lymphoblastic leukemia sub-type or indication, an acute promyelocytic leukemia sub-type or indication, and an acute myeloid leukemia sub-type or indication.
- Claim: 18. The system according to claim 1, wherein the subset comprises a calculated parameter, wherein the calculated parameter is based on a function of at least two measures of cell population data, and wherein the acute leukemic sub-type is assigned based at least in part on the calculated parameter.
- Claim: 19. The system according to claim 1, wherein the predicted acute leukemic sub-type is an acute lymphoblastic leukemia indication, and the subset comprises a volume parameter (V), a conductivity parameter (C), a low angle light scatter parameter (LALS), a lower median angle light scatter parameter (LMALS), an upper median angle light scatter parameter (UMALS), and an axial light loss parameter (AL2).
- Claim: 20. The system according to claim 1, wherein the predicted acute leukemic sub-type is an acute lymphoblastic leukemia indication, and the subset comprises a neutrophil calculated parameter (NE), a monocyte calculated parameter (MO), an eosinophil calculated parameter (EO), and a non-nucleated red blood cell calculated parameter (NNRBC).
- Claim: 21. The system or method according to claim 20, wherein: (i) the neutrophil calculated parameter is based on a ratio of a neutrophil upper median angle light scatter parameter to a neutrophil median angle light scatter parameter, the neutrophil median angle light scatter parameter comprising the sum of the neutrophil upper median angle light scatter parameter and a neutrophil lower median angle light scatter parameter; and/or (ii) wherein the monocyte calculated parameter comprises a member selected from the group consisting of: a ratio of a monocyte conductivity parameter to a monocyte volume parameter, a ratio of a monocyte low angle light scatter parameter to a monocyte axial light loss parameter, a ratio of a monocyte volume parameter to a monocyte axial light loss parameter, a ratio of a monocyte upper median angle light scatter to a monocyte volume parameter, a ratio of a monocyte low angle light scatter parameter to a monocyte volume parameter, a ratio of a monocyte low angle light scatter parameter to a monocyte median angle light scatter parameter, the monocyte median angle light scatter parameter comprising the sum of a monocyte upper median angle light scatter parameter and a monocyte lower median angle light scatter parameter, a ratio of a monocyte upper median angle light scatter parameter to a monocyte median angle light scatter parameter, the monocyte median angle light scatter parameter comprising the sum of the monocyte upper median angle light scatter parameter and a monocyte lower median angle light scatter parameter, and a ratio of a monocyte lower median angle light scatter parameter to a monocyte median angle light scatter parameter, the monocyte median angle light scatter parameter comprising the sum of a monocyte upper median angle light scatter parameter and the monocyte lower median angle light scatter parameter; and/or (iii) wherein the eosinophil calculated parameter comprises a ratio of an eosinophil lower median angle light scatter parameter to an eosinophil median angle light scatter parameter, the eosinophil median angle light scatter parameter comprising the sum of an eosinophil upper median angle light scatter parameter and the eosinophil lower median angle light scatter parameter; and/or (iv) wherein the non-nucleated red blood cell calculated parameter comprises a member selected from the group consisting of: a ratio of a non-nucleated red blood cell lower median angle light scatter parameter to a non-nucleated red blood cell axial light loss parameter, a ratio of a non-nucleated red blood cell low angle light scatter parameter to a non-nucleated red blood cell axial light loss parameter, and a ratio of a non-nucleated red blood cell lower median angle light scatter parameter to a non-nucleated red blood cell median angle light scatter parameter, the non-nucleated red blood cell median angle light scatter parameter comprising the sum of a non-nucleated red blood cell upper median angle light scatter parameter and the non-nucleated red blood cell lower median angle light scatter parameter.
- Claim: 22. The system according to claim 1, wherein the predicted acute leukemic sub-type is an acute promyelocytic leukemia indication determined based on a volume parameter (V), a conductivity parameter (C), a low angle light scatter parameter (LALS), a lower median angle light scatter parameter (LMALS), an upper median angle light scatter parameter (UMALS), and an axial light loss parameter (AL2).
- Claim: 23. The system according to claim 1, wherein the predicted acute leukemic sub-type is an acute promyelocytic leukemia indication based on a neutrophil calculated parameter (NE), a lymphocyte calculated parameter (LY), an eosinophil calculated parameter (EO), and a non-nucleated red blood cell calculated parameter (NNRBC).
- Claim: 24. The system according to claim 1, wherein the subset is determined based on a pre-defined specificity and/or sensitivity for acute leukemia.
- Claim: 25. The system according to claim 1, wherein the subset comprises a calculated parameter for identifying acute lymphoblastic leukemia or a calculated parameter for identifying acute promyelocyte leukemia.
- Claim: 26. A method for predicting an acute leukemia sub-type of 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 acute leukemic sub-type of the individual.
- Claim: 27. The method according to claim 26, 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: 28. The method according to claim 26, 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: 29. The method according to claim 26, wherein the subset comprises: (i) DC impedance measurements for lymphocytes, monocytes, eosinophils, and non-nucleated red blood cells of the biological sample; (ii) RF conductivity, ALL, LALS, UMALS, and LMALS measurements for neutrophils of the biological sample; (iii) a neutrophil measurement, a monocyte measurement, an eosinophil measurement, a non-nucleated red blood cell measurement, or a combination of two or more thereof, and wherein the acute leukemic sub-type comprises acute lymphoblastic leukemia (ALL); (iv) a standard deviation high frequency current neutrophil measurement, a mean upper median angle light scatter neutrophil measurement, a standard deviation upper median angle light scatter neutrophil measurement, a standard deviation low angle light scatter neutrophil measurement, standard deviation axial light loss neutrophil measurement, a mean low frequency current lymphocyte measurement, a mean high frequency current lymphocyte measurement, a standard deviation high frequency current lymphocyte measurement, a mean low angle light scatter lymphocyte measurement, a mean axial light loss lymphocyte measurement, a mean low frequency current monocyte measurement, a standard deviation low frequency current monocyte measurement, a mean high frequency current monocyte measurement, a standard deviation high frequency current monocyte measurement, a mean lower median angle light scatter monocyte measurement, a mean low angle light scatter monocyte measurement, a mean axial light loss monocyte measurement, a mean low frequency current eosinophil measurement, a standard deviation low frequency eosinophil measurement, a mean lower median angle light scatter eosinophil measurement, a mean high frequency current non-nucleated red blood cell measurement, a standard deviation high frequency current non-nucleated red blood cell measurement, a standard deviation upper median angle light scatter non-nucleated red blood measurement, or a combination of two or more thereof; (v) a neutrophil calculated parameter, a monocyte calculated parameter, an eosinophil calculated parameter, a non-nucleated red blood cell calculated parameter, or a combination of two or more thereof, and wherein the acute leukemic sub-type comprises acute lymphoblastic leukemia (ALL); or (vi) a calculated parameter based on a function of at least two parameters selected from the group consisting of the axial light loss measurement of the sample, a low frequency current measurement of the sample, a high 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 an upper median angle light scatter measurement of the sample.
- Claim: 30. The method according to claim 26, wherein the subset comprises a calculated parameter based on a function of at least two neutrophil measurements.
- Claim: 31. The method according to claim 30, wherein: (i) the at least two neutrophil measurements are selected from the group consisting of a neutrophil upper median angle light scatter measurement, a neutrophil median angle light scatter measurement, and a neutrophil lower median angle light scatter measurement; or (ii) the calculated parameter is based on a ratio of a neutrophil upper median angle light scatter measurement to a neutrophil median angle light scatter measurement, the neutrophil median angle light scatter measurement comprising the sum of the neutrophil upper median angle light scatter measurement and a neutrophil lower median angle light scatter measurement.
- Claim: 32. The method according to claim 26, wherein the subset comprises a calculated parameter based on a function of at least two monocyte measurements.
- Claim: 33. The method according to claim 32, wherein: (i) the at least two monocyte measurements are selected from the group consisting of a monocyte high frequency current measurement, a monocyte low frequency current measurement, a monocyte axial light loss measurement, a monocyte median angle light scatter measurement, a monocyte low angle light scatter measurement, a monocyte upper median angle light scatter measurement, and a monocyte lower median angle light scatter measurement; or (ii) the calculated parameter comprises a member selected from the group consisting of: a ratio of a monocyte high frequency current measurement to a monocyte low frequency current measurement, a ratio of a monocyte low angle light scatter measurement to a monocyte axial light loss measurement, a ratio of a monocyte low frequency current measurement to a monocyte axial light loss measurement, a ratio of a monocyte upper median angle light scatter measurement to a monocyte low frequency current measurement, a ratio of a monocyte low angle light scatter measurement to a monocyte low frequency current measurement, a ratio of a monocyte low angle light scatter measurement to a monocyte median angle light scatter measurement, the monocyte median angle light scatter measurement comprising the sum of a monocyte upper median angle light scatter measurement and a monocyte lower median angle light scatter measurement, a ratio of a monocyte upper median angle light scatter measurement to a monocyte median angle light scatter measurement, the monocyte median angle light scatter measurement comprising the sum of the monocyte upper median angle light scatter measurement and a monocyte lower median angle light scatter measurement, and a ratio of a monocyte lower median angle light scatter measurement to a monocyte median angle light scatter measurement, the monocyte median angle light scatter measurement comprising the sum of a monocyte upper median angle light scatter measurement and the monocyte lower median angle light scatter measurement.
- Claim: 34. The method according to claim 26, wherein the subset comprises a calculated parameter based on a function of at least two eosinophil measurements.
- Claim: 35. The method according to claim 34, wherein: (i) the at least two eosinophil measurements are selected from the group consisting of an eosinophil lower median angle light scatter measurement, an eosinophil median angle light scatter measurement, and an eosinophil upper median angle light scatter measurement; or (ii) the calculated parameter comprises a ratio of an eosinophil lower median angle light scatter measurement to an eosinophil median angle light scatter measurement, the eosinophil median angle light scatter measurement comprising the sum of an eosinophil upper median angle light scatter measurement and the eosinophil lower median angle light scatter measurement.
- Claim: 36. The method according to claim 26, wherein the subset comprises a calculated parameter based on a function of at least two non-nucleated red blood cell measurements.
- Claim: 37. The method according to claim 36, wherein: (i) the at least two non-nucleated red blood cell measurements are selected from the group consisting of a non-nucleated red blood cell lower median angle light scatter measurement, a non-nucleated red blood cell axial light loss measurement, a non-nucleated red blood cell low angle light scatter measurement, a non-nucleated red blood cell median angle light scatter measurement, and a non-nucleated red blood cell upper median angle light scatter measurement; or (ii) the calculated parameter comprises a member selected from the group consisting of: a ratio of a non-nucleated red blood cell lower median angle light scatter measurement to a non-nucleated red blood cell axial light loss measurement, a ratio of a non-nucleated red blood cell low angle light scatter measurement to a non-nucleated red blood cell axial light loss measurement, and a ratio of a non-nucleated red blood cell lower median angle light scatter measurement to a non-nucleated red blood cell median angle light scatter measurement, the non-nucleated red blood cell median angle light scatter measurement comprising the sum of a non-nucleated red blood cell upper median angle light scatter measurement and the non-nucleated red blood cell lower median angle light scatter measurement.
- Claim: 38. The method according to claim 26, wherein the subset comprises: (a) a neutrophil measurement, a monocyte measurement, an eosinophil measurement, a non-nucleated red blood cell measurement, or a combination of two or more thereof, and wherein the acute leukemic sub-type comprises acute promyelocytic leukemia (APL); or (b) a mean low angle light scatter neutrophil measurement, a mean median angle light scatter neutrophil measurement, a mean low frequency current lymphocyte measurement, a mean low frequency current monocyte measurement, a mean lower median angle light scatter monocyte measurement, a standard deviation axial light loss monocyte measurement, a mean median angle light scatter eosinophil measurement, a mean low frequency current non-nucleated red blood cell measurement, a standard deviation median angle light scatter non-nucleated red blood cell measurement, or a combination of two or more thereof.
- Claim: 39. The method according to claim 26, wherein the subset comprises a neutrophil calculated parameter, a lymphocyte calculated parameter, an eosinophil calculated parameter, a non-nucleated red blood cell calculated parameter, or a combination of two or more thereof, and wherein the acute leukemic sub-type comprises acute promyelocytic leukemia (APL).
- Claim: 40. The method according to claim 39, wherein: (i) the neutrophil calculated parameter comprises a ratio of a neutrophil high frequency current measurement to a neutrophil axial light loss measurement; (ii) the lymphocyte calculated parameter comprises a ratio of a lymphocyte lower median angle light scatter measurement to a lymphocyte mean median angle light scatter measurement; (iii) the eosinophil calculated parameter comprises a ratio of an eosinophil lower median angle light scatter measurement to a eosinophil axial light loss measurement; or (iv) the non-nucleated red blood cell calculated parameter comprises a ratio of a non-nucleated red blood cell low angle light scatter measurement to a non-nucleated red blood cell low frequency current measurement.
- Claim: 41. The method according to claim 26, 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: 42. The method according to claim 26, wherein the acute leukemic sub-type comprises a member selected from the group consisting of an acute lymphoblastic leukemia sub-type or indication, an acute promyelocytic leukemia sub-type or indication, and an acute myeloid leukemia sub-type or indication.
- Claim: 43. The method according to claim 26, wherein the subset comprises a calculated parameter, wherein the calculated parameter is based on a function of at least two measures of cell population data, and wherein the acute leukemic sub-type is assigned based at least in part on the calculated parameter.
- Claim: 44. The method according to claim 26, wherein the predicted acute leukemic sub-type is an acute lymphoblastic leukemia indication, and the subset comprises a volume parameter (V), a conductivity parameter (C), a low angle light scatter parameter (LALS), a lower median angle light scatter parameter (LMALS), an upper median angle light scatter parameter (UMALS), and an axial light loss parameter (AL2).
- Claim: 45. The method according to claim 26, wherein the predicted acute leukemic sub-type is an acute lymphoblastic leukemia indication, and the subset comprises a neutrophil calculated parameter (NE), a monocyte calculated parameter (MO), an eosinophil calculated parameter (EO), and a non-nucleated red blood cell calculated parameter (NNRBC).
- Claim: 46. The method according to claim 45, wherein: (i) the neutrophil calculated parameter is based on a ratio of a neutrophil upper median angle light scatter parameter to a neutrophil median angle light scatter parameter, the neutrophil median angle light scatter parameter comprising the sum of the neutrophil upper median angle light scatter parameter and a neutrophil lower median angle light scatter parameter; and/or (ii) wherein the monocyte calculated parameter comprises a member selected from the group consisting of: a ratio of a monocyte conductivity parameter to a monocyte volume parameter, a ratio of a monocyte low angle light scatter parameter to a monocyte axial light loss parameter, a ratio of a monocyte volume parameter to a monocyte axial light loss parameter, a ratio of a monocyte upper median angle light scatter to a monocyte volume parameter, a ratio of a monocyte low angle light scatter parameter to a monocyte volume parameter, a ratio of a monocyte low angle light scatter parameter to a monocyte median angle light scatter parameter, the monocyte median angle light scatter parameter comprising the sum of a monocyte upper median angle light scatter parameter and a monocyte lower median angle light scatter parameter, a ratio of a monocyte upper median angle light scatter parameter to a monocyte median angle light scatter parameter, the monocyte median angle light scatter parameter comprising the sum of the monocyte upper median angle light scatter parameter and a monocyte lower median angle light scatter parameter, and a ratio of a monocyte lower median angle light scatter parameter to a monocyte median angle light scatter parameter, the monocyte median angle light scatter parameter comprising the sum of a monocyte upper median angle light scatter parameter and the monocyte lower median angle light scatter parameter; and/or (iii) wherein the eosinophil calculated parameter comprises a ratio of an eosinophil lower median angle light scatter parameter to an eosinophil median angle light scatter parameter, the eosinophil median angle light scatter parameter comprising the sum of an eosinophil upper median angle light scatter parameter and the eosinophil lower median angle light scatter parameter; and/or (iv) wherein the non-nucleated red blood cell calculated parameter comprises a member selected from the group consisting of: a ratio of a non-nucleated red blood cell lower median angle light scatter parameter to a non-nucleated red blood cell axial light loss parameter, a ratio of a non-nucleated red blood cell low angle light scatter parameter to a non-nucleated red blood cell axial light loss parameter, and a ratio of a non-nucleated red blood cell lower median angle light scatter parameter to a non-nucleated red blood cell median angle light scatter parameter, the non-nucleated red blood cell median angle light scatter parameter comprising the sum of a non-nucleated red blood cell upper median angle light scatter parameter and the non-nucleated red blood cell lower median angle light scatter parameter.
- Claim: 47. The method according to claim 26, wherein the predicted acute leukemic sub-type is an acute promyelocytic leukemia indication determined based on a volume parameter (V), a conductivity parameter (C), a low angle light scatter parameter (LALS), a lower median angle light scatter parameter (LMALS), an upper median angle light scatter parameter (UMALS), and an axial light loss parameter (AL2).
- Claim: 48. The method according to claim 26, wherein the predicted acute leukemic sub-type is an acute promyelocytic leukemia indication based on a neutrophil calculated parameter (NE), a lymphocyte calculated parameter (LY), an eosinophil calculated parameter (EO), and a non-nucleated red blood cell calculated parameter (NNRBC).
- Claim: 49. The method according to claim 26, wherein the subset is determined based on a pre-defined specificity and/or sensitivity for acute leukemia.
- Claim: 50. The method according to claim 26, wherein the subset comprises a calculated parameter for identifying acute lymphoblastic leukemia or a calculated parameter for identifying acute promyelocyte leukemia.
- Claim: 51. 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, an acute leukemia sub-type physiological 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 acute leukemia sub-type physiological status.
- Claim: 52. An automated system for predicting an acute leukemia sub-type 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 sub-type of an acute leukemia of the individual; and (iii) output from the processor information relating to the predicted sub-type of the leukemia.
- Claim: 53. An automated method for predicting an acute leukemia sub-type 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 sub-type of an acute leukemia of the individual by executing, with the processor, the storage medium; and (c) outputting from the processor information relating to the predicted sub-type of the leukemia.
- Current U.S. Class: 702/21
- Current International Class: 01; 06
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