Method and apparatus for rapid measurement of HbA1c
First Claim
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1. A method of determining a diabetic patient'"'"'s compliance with their insulin dosing regime comprising:
- (i) obtaining an untreated blood specimen from said patient;
(ii) measuring with a spectrophotometer, absorbance of radiation by each of HbA1c and total Hb in said specimen, the radiation being directed into said specimen in a direction that is substantially parallel to the direction in which red blood cells in said specimen fall under the effect of gravity;
(iii) using a calibration algorithm for each of said HbA1c and total Hb to calculate a concentration of each of said HbA1c and total Hb in said specimen from said absorbances measured in step (ii); and
(iv) determining a ratio between the concentrations of HbA1c and total Hb, wherein an elevated concentration ratio of HbA1c to total Hb reflects a lack of patient compliance.
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Abstract
Described is a method and apparatus for determining a diabetic patient'"'"'s compliance with their insulin dosing regime. The method and apparatus involves taking a blood sample from a patient by a routine finger prick and placing it in a special sample tab which is placed in a spectrophotometer sample housing. The spectrophotometer measures Hb and HbA1c concentrations and allows for calculating a ratio of HbA1c to Hb which is indicative of the degree of patient compliance.
92 Citations
27 Claims
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1. A method of determining a diabetic patient'"'"'s compliance with their insulin dosing regime comprising:
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(i) obtaining an untreated blood specimen from said patient;
(ii) measuring with a spectrophotometer, absorbance of radiation by each of HbA1c and total Hb in said specimen, the radiation being directed into said specimen in a direction that is substantially parallel to the direction in which red blood cells in said specimen fall under the effect of gravity;
(iii) using a calibration algorithm for each of said HbA1c and total Hb to calculate a concentration of each of said HbA1c and total Hb in said specimen from said absorbances measured in step (ii); and
(iv) determining a ratio between the concentrations of HbA1c and total Hb, wherein an elevated concentration ratio of HbA1c to total Hb reflects a lack of patient compliance. - View Dependent Claims (2, 3, 4)
wherein said sample tab comprises a well in which the specimen resides and a cover which closes over the well, and wherein said sample tab is transparent or translucent.
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5. A method of determining a diabetic patient'"'"'s compliance with their insulin dosing regime comprising:
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(i) generating a calibration algorithm for each of HbA1c and total Hb;
(ii) obtaining an untreated blood specimen from said patient;
(iii) measuring with a spectrophotometer, absorbance of radiation by each of HbA1c and total Hb in said specimen, the radiation being directed into said specimen in a direction that is substantially parallel to the direction in which red blood cells in said specimen fall under the effect of gravity;
(iv) using said calibration algorithms generated in step (i) to calculate a concentration of each of said HbA1c and total Hb in said specimen from said absorbances measured in step (iii); and
(v) determining a ratio between the concentrations of HbA1c and total Hb, wherein an elevated concentration ratio of HbA1c to total Hb reflects a lack of patient compliance. 6.The method of claim 5, wherein said step of using (step iv), includes a step for calculating a first derivative of at least two portions of a spectrum generated from an absorbance scan for each of HbA1c and total Hb. - View Dependent Claims (6, 7)
wherein said sample tab comprises a well in which the specimen resides and a cover which closes over the well, and wherein said sample tab is transparent or translucent.
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8. A method of assessing the control of diabetes in a patient comprising:
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(i) obtaining an untreated blood specimen from said patient;
(ii) measuring with a spectrophotometer, absorbance of radiation by each of HbA1c and total Hb in said specimen, the radiation being directed into said specimen in a direction that is substantially parallel to the direction in which red blood cells in said specimen fall under the effect of gravity;
(iii) using a calibration algorithm for each of said HbA1c and total Hb to calculate a concentration of each of said HbA1c and total Hb in said specimen from said absorbances measured in step (ii); and
(iv) determining a ratio between the concentrations of HbA1c and total Hb, wherein an elevated concentration ratio of HbA1c to total Hb reflects a lack of control of diabetes.
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- 9. The method of claim 9, wherein said step of using (step iii), includes a step for calculating a first derivative of at least two portions of a spectrum generated from an absorbance scan for each of HbA1c and total Hb.
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13. A method of assessing the control of diabetes in a patient comprising:
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(i) obtaining an untreated blood specimen from said patient;
(ii) measuring with a spectrophotometer, absorbance of radiation by each of HbA1c and total Hb in said specimen, the radiation being directed into said specimen in a direction that is substantially parallel to the direction in which red blood cells in said specimen fall under the effect of gravity; and
(iii) using a calibration algorithm to calculate a concentration ratio of said HbA1c to total Hb in said specimen from said absorbances measured in step (ii), wherein an elevated ratio of HbA1c to total Hb reflects a lack of control of diabetes.
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- 14. The method of claim 14, wherein said step of using (step iii), includes a step for calculating a first derivative of at least two portions of a spectrum generated from an absorbance scan for each of HbA1c and total Hb.
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18. A method of assessing the control of diabetes in a patient comprising:
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(i) generating a calibration algorithm for each of HbA1c and total Hb;
(ii) obtaining an untreated blood specimen from said patient;
(iii) measuring with a spectrophotometer, absorbance of radiation by each of HbA1c and total Hb in said specimen, the radiation being directed into said specimen in a direction that is substantially parallel to the direction in which red blood cells in said specimen fall under the effect of gravity;
(iv) using said calibration algorithms generated in step (i) to calculate a concentration of each of said HbA1c and total Hb in said specimen from said absorbances measured in step (iii); and
(v) determining a ratio between the concentrations of HbA1c and total Hb, wherein an elevated concentration ratio of HbA1c to total Hb reflects a lack of control of diabetes.
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- 19. The method of claim 19, wherein said step of using (step iv), includes a step for calculating a first derivative of at least two portions of a spectrum generated from an absorbance scan for each of HbA1c and total Hb.
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23. A method of assessing the control of diabetes in a patient comprising:
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(i) generating a calibration algorithm for both of HbA1c and total Hb;
(ii) obtaining an untreated blood specimen from said patient;
(iii) measuring with a spectrophotometer, absorbance of radiation by each of HbA1c and total Hb in said specimen, the radiation being directed into said specimen in a direction that is substantially parallel to the direction in which red blood cells in said specimen fall under the effect of gravity; and
(iv) using said calibration algorithms to calculate a concentration ratio of said HbA1c to total Hb in said specimen from said absorbances measured in step (iii), wherein an elevated concentration ratio of HbA1c to total Hb reflects a lack of control of diabetes.
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- 24. The method of claim 24, wherein said step of using (step iv), includes a step for calculating a first derivative of at least two portions of a spectrum generated from an absorbance scan for each of HbA1c and total Hb.
Specification