Bibliographic Details
| Title: |
Method for Flagging a Sample |
| Document Number: |
20110045525 |
| Publication Date: |
February 24, 2011 |
| Appl. No: |
12/546552 |
| Application Filed: |
August 24, 2009 |
| Abstract: |
A hematology analyzer is provided. In certain embodiments, the hematology analyzer comprises: a) a flow cell; b) a light source for directing light to the flow cell; c) a plurality of detectors for detecting a plurality of optical characteristics of a blood cell passing through the flow cell; and d) a data analysis workstation programmed to: i. enumerate test blood cells passing through the flow cell; and ii. flag a blood sample as containing lysis-resistant red blood cells or fragile white blood cells. |
| Inventors: |
Krockenberger, Martin (Los Gatos, CA, US); Bordenkircher, Richard B. (Meridian, ID, US); Garrett, Diana G. (Scotts Valley, CA, US); Glazier, John G. (San Jose, CA, US); Bearden, James C. (Milpitas, CA, US); Roemer, Bodo (US); Vacca, Giacomo (San Jose, CA, US) |
| Claim: |
1. A hematology analyzer comprising: a) a flow cell; b) a light source for directing light to said flow cell; c) a plurality of detectors for detecting a plurality of optical characteristics of a blood cell passing through said flow cell; and d) a data analysis workstation programmed to: i. enumerate test blood cells passing through said flow cell; and ii. flag a blood sample as containing lysis-resistant red blood cells or fragile white blood cells by: analyzing data for said test blood cells to produce a value that describes a characteristic of said test blood cells; comparing said value to a criterion obtained from analysis of a plurality of reference samples; and flagging said blood sample as containing lysis-resistant red blood cells or fragile white blood cells if said value meets said criterion. |
| Claim: |
2. The hematology analyzer of claim 1, wherein said detectors detect axial light loss (ALL), intermediate angle scatter (IAS) and depolarized side scatter (DSS). |
| Claim: |
3. The hematology analyzer of claim 1, wherein said data analysis workstation comprises a memory comprising data obtained from at least 50 prior reference samples analyzed by said hematology analyzer. |
| Claim: |
4. The hematology analyzer of claim 3, wherein said data analysis workstation is programmed to update said data continuously as blood samples are analyzed on said analyzer. |
| Claim: |
5. The hematology analyzer of claim 3, wherein said value is obtained by comparing data for said test blood cells to said data obtained from said at least 50 reference samples. |
| Claim: |
6. The hematology analyzer of claim 1, wherein said criterion is a static criterion obtained from data from at least 50 fixed reference samples. |
| Claim: |
7. The hematology analyzer of claim 1, wherein said hematology analyzer produces a report flagging said lysed sample of blood as containing lysis-resistant red blood cells or fragile white blood cells, if the value meets said criterion. |
| Claim: |
8. The hematology analyzer of claim 1, wherein: said value indicates the rate of decrease in the number of said cells in said lysed sample over a period of time; and said lysed sample of blood is flagged if said rate of decrease is significantly greater than the average rate of decrease in the number of cells in said reference samples of lysed blood. |
| Claim: |
9. The hematology analyzer of claim 8, wherein said value indicates the rate of decrease in the total number of said cells in said lysed sample over a period of time; and said lysed sample of blood is flagged if said rate of decrease is significantly greater than the average rate of decrease in the total number of cells in said reference samples of lysed blood. |
| Claim: |
10. The hematology analyzer of claim 8, wherein said value indicates the rate of decrease in the number of cells classified as lymphocytes in said lysed sample over a period of time; and said lysed sample of blood is flagged if said rate of decrease is significantly greater than the average rate of decrease in the number of cells classified as lymphocytes in said reference samples of lysed blood. |
| Claim: |
11. The hematology analyzer of claim 8, wherein said value indicates an increasing or decreasing rate of decrease in the number of cells classified as lymphocytes over said period of time, wherein: an increasing rate of decrease indicates that said lysed sample of blood contains fragile white blood cells; and a decreasing rate of decrease indicates that said lysed sample of blood contains lysis-resistant red blood cells. |
| Claim: |
12. The hematology analyzer of claim 1, wherein: said data comprises the axial light loss (ALL) and intermediate angle scatter (IAS) values for cells classified as lymphocytes; and said value is based on the mean ALL and IAS values for said cells; and said criterion is based on the median of the means of ALL and IAS values for said reference cells. |
| Claim: |
13. The hematology analyzer of claim 12, wherein: said value is the distance between the mean ALL and IAS values for said cells in said lysed sample and the median of the mean ALL and IAS values for at least 50 reference samples previously analyzed by said hematology analyzer. |
| Claim: |
14. The hematology analyzer claim 1, wherein: said data comprises ALL and IAS values for cells classified as lymphocytes; said value is the ratio composed of: a) the number of cells classified as lymphocytes defined by pre-determined ALL and IAS limits, divided by b) the number of cells classified as lymphocytes defined by ALL and IAS limits that are adjacent to said pre-determined ALL and IAS limits; and said criterion is based on the number of cells classified as lymphocytes defined by pre-determined ALL and IAS limits, versus the number of cells classified as lymphocytes defined by ALL and IAS limits that are adjacent to said pre-determined ALL and IAS limits for said reference samples. |
| Claim: |
15. The hematology analyzer of claim 1, wherein: said data comprises the depolarized side scatter (DSS) values for cells classified as lymphocytes; said value indicates the degree of distribution and/or skew of said DSS values; and said criterion is based on the degree of distribution and/or skew of DSS values for said reference samples. |
| Claim: |
16. The hematology analyzer of claim 1, wherein said data comprises the depolarized side scatter (DSS) values for cells classified as lymphocytes; said value indicates the number of zero-bin datapoints in the distribution said DSS values; and said criterion is based on the number of zero-bin datapoints in the distribution of DSS values for said reference samples. |
| Claim: |
17. The hematology analyzer of claim 1, wherein said method comprises calculating a plurality of values for a corresponding plurality of different characteristics of said cells, comparing said values to a corresponding plurality of different criteria obtained from analysis of a plurality of reference samples to produce a plurality of scores; and flagging said blood sample as containing lysis-resistant red blood cells or fragile white blood cells if the sum of said scores exceeds a threshold. |
| Claim: |
18. The hematology analyzer of claim 17, wherein said flagging comprises weighting said scores to produce said sum. |
| Claim: |
19. A method for flagging a sample of blood as containing lysis-resistant red blood cells or fragile white blood cells, comprising: a) lysing red blood cells in a whole blood sample to produce a lysed sample of blood; b) subjecting a lysed sample of blood to analysis using a hematology analyzer to obtain data for cells in said lysed sample; c) analyzing said data to provide a value that describes a characteristic of said cells; d) comparing said value to a criterion obtained from analysis of a plurality of reference samples of lysed blood; and e) flagging said lysed sample of blood as containing lysis-resistant red blood cells or fragile white blood cells if said value meets said criterion. |
| Claim: |
20. A physical computer-readable medium for use on a hematology analyzer, comprising programming to: flag a blood sample as containing lysis-resistant red blood cells or fragile white blood cells by: analyzing data for test blood cells analyzed by said hematology analyzer to produce a value that describes a characteristic of said test blood cells; comparing said value to a criterion obtained from analysis of a plurality of reference samples comprising reference blood cells; and flagging said blood sample as containing lysis-resistant red blood cells or fragile white blood cells if said value meets said criterion. |
| Current U.S. Class: |
435/34 |
| Current International Class: |
12; 12 |
| Accession Number: |
edspap.20110045525 |
| Database: |
USPTO Patent Applications |
