Methods for Performing Hematocrit Adjustment in Glucose Assays and Devices for Same
First Claim
1. A method for adjusting glucose bias, if any, of a blood sample in a glucose-monitoring product comprising the acts of:
- (a) measuring the glucose value, Glum, of the blood sample;
(b) measuring the resistance of the blood sample, Rcell, using a biosensor reagent;
(c) measuring the resistance of plasma, Rplasma, using the biosensor reagent;
(d) determining the calculated resistance of red blood cells, RRBC, of the blood sample according to the relationship;
RRBC=Rcell−
Rplasma;
(e) calculating the percent hematocrit, % Hctc, of the blood sample;
(f) determining whether to adjust the glucose value, Glum, to an adjusted glucose value, Gluadj; and
(g) using the percent hematocrit, % Hctc, and the glucose value Glum, from either act (a) or act (f) to adjust for the bias of the biosensor reagent, if any.
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Abstract
Methods and devices for performing in situ hematocrit adjustments during glucose testing using glucose-monitoring products and using those adjusted values to estimate the hematocrit value of blood samples to reduce or eliminate the assay bias caused by the different hematocrit levels of blood samples. One method involves measuring the glucose value, Glum, of the blood sample; measuring the resistance of the blood sample (Rcell) using a biosensor reagent; measuring the resistance of plasma (Rplasma) using the biosensor reagent; determining the calculated resistance of red blood cells, RRBC, of the blood sample according to the relationship
RRBC=Rcell−Rplasma;
calculating the percent hematocrit, % Hctc, of the blood sample; determining whether to adjust the glucose value, Glum, to an adjusted glucose value, Gluadj; and using the percent hematocrit, % Hctc, and either the glucose value, Glum, or the adjusted glucose value, Gluadj, to adjust for any bias of the biosensor reagent.
62 Citations
30 Claims
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1. A method for adjusting glucose bias, if any, of a blood sample in a glucose-monitoring product comprising the acts of:
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(a) measuring the glucose value, Glum, of the blood sample;
(b) measuring the resistance of the blood sample, Rcell, using a biosensor reagent;
(c) measuring the resistance of plasma, Rplasma, using the biosensor reagent;
(d) determining the calculated resistance of red blood cells, RRBC, of the blood sample according to the relationship;
RRBC=Rcell−
Rplasma;
(e) calculating the percent hematocrit, % Hctc, of the blood sample;
(f) determining whether to adjust the glucose value, Glum, to an adjusted glucose value, Gluadj; and
(g) using the percent hematocrit, % Hctc, and the glucose value Glum, from either act (a) or act (f) to adjust for the bias of the biosensor reagent, if any. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. A method for adjusting glucose bias, if any, of a blood sample in a glucose-monitoring product, the method comprising the acts of:
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measuring the glucose value, Glum, of the blood sample;
measuring the cell resistance, Rcell, of the blood sample using a biosensor reagent;
measuring the plasma resistance, Rplasma, of the blood sample using a biosensor reagent;
determining the calculated resistance of red blood cells, RRBC, of the blood sample according to the relationship;
RRBC=Rcell−
Rplasma;
calculating the percent hematocrit, % Hctc, of the blood sample according to the relationship;
% Hctc=−
k1*(RRBC)2+k2*RRBC+k3where k1 ranges from about +100 to about −
100, k2 ranges from about +100 to about −
100, and k3 ranges from about +100 to about −
100;
determining whether to adjust the glucose value, Glum; and
adjusting, if necessary, the glucose value, Glum, using the percent hematocrit, % Hctc, and the glucose value Glum according to the relationship;
Gluadj=Glum+k5. - View Dependent Claims (16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28)
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29. A meter for correcting glucose bias of a blood sample in a glucose-monitoring product, the meter comprising:
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means for measuring the glucose value, Glum, of the blood sample;
means for measuring the resistance of the blood sample, Rcell, using a biosensor reagent;
means for measuring the resistance of plasma, Rplasma, using the biosensor reagent;
means for determining the calculated resistance of red blood cells, RRBC, of the blood sample according to the relationship;
RRBC=Rcell−
Rplasma;
means for calculating the percent hematocrit, % Hctc, of the blood sample;
means for determining whether to adjust the glucose value, Glum, to an adjusted glucose value, Gluadj; and
means for using the percent hematocrit, % Hctc, and either the glucose value, Glum, or the adjusted glucose value, Gluadj, to adjust for the bias of the biosensor reagent, if any.
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30. A meter for correcting glucose bias of a blood sample in a glucose-monitoring product, the meter comprising:
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means for measuring the glucose value, Glum, of the blood sample;
means for measuring the cell resistance, Rcell, of the blood sample using a biosensor reagent;
means for measuring the plasma resistance, Rplasma, of the blood sample using a biosensor reagent;
means for determining the calculated resistance of red blood cells, RRBC, of the blood sample according to the relationship;
RRBC=Rcell−
Rplasma;
means for calculating the percent hematocrit, % Hctc, of the blood sample according to the relationship;
% Hctc=−
k1*(RRBC)2+k2*RRBC+k3where k1 ranges from about +100 to about −
100, k2 ranges from about +100 to about −
100, and k3 ranges from about +100 to about −
100;
means for determining whether to adjust the glucose value, Glum; and
means for adjusting, if necessary, the glucose value, Glum, using the percent hematocrit, % Hctc, and the glucose value Glum according to the relationship;
Gluadj=Glum+k5.
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Specification