US2018188200A1PendingUtilityA1
Accurate analyte measurements for electrochemical test strip based on sensed physical characteristic(s) of the sample containing the analyte and derived biosensor parameters
Est. expiryDec 29, 2031(~5.5 yrs left)· nominal 20-yr term from priority
G01N 27/26G01N 27/3272G01N 27/327G01N 27/3274G16B 40/00G06F 19/24G16B 40/10
68
PatentIndex Score
0
Cited by
0
References
0
Claims
Abstract
Various embodiments for a method that allow for a more accurate analyte concentration with a biosensor by determining at least one physical characteristic of the sample containing the analyte and deriving a parameter relating to the biosensor to attain accurate glucose concentration.
Claims
exact text as granted — not AI-modified1 . A method of determining an analyte concentration from a fluid sample with a biosensor having at least two electrodes and a reagent disposed on at least one of the electrodes, the method comprising:
depositing a fluid sample on at least one electrode to start an analyte test sequence; applying a signal to the sample to determine a physical characteristic of the sample; driving another signal to the sample to cause a physical transformation of the sample; measuring at least one output signal from the sample; obtaining an estimated analyte concentration from the at least one output signal at one of a plurality of predetermined time positions from the start of the test sequence and at least one predetermined parameter of the biosensor; generating a first parametric factor of the biosensor based on the physical characteristic of the sample; calculating a first analyte concentration based on the first parametric factor of the biosensor and at least one output signal measured at one of the plurality of predetermined time positions from the start of the test sequence; generating a second parametric factor of the biosensor based on the estimated analyte concentration and the physical characteristic of the sample; calculating a second analyte concentration based on the second parametric factor of the biosensor and at least one output signal measured at one of the plurality of predetermined time positions from the start of the test sequence; generating a third parametric factor of the biosensor based on the first analyte concentration and the physical characteristic; calculating a third analyte concentration based on the third parametric factor of the biosensor and at least one output signal measured at one of the plurality of predetermined time positions from the start of the test sequence; and annunciating at least one of the first, second, and third analyte concentrations.
2 . A method of determining an analyte concentration from a fluid sample with a biosensor having at least two electrodes and a reagent disposed on at least one of the electrodes, the method comprising:
starting an analyte test sequence upon deposition of a sample; applying a signal to the sample to determine a physical characteristic of the sample; driving another signal to the sample to cause a physical transformation of the sample; measuring at least one output signal from the sample; deriving an estimated analyte concentration from the at least one output signal measured at one of a plurality of predetermined time positions from the start of the test sequence; obtaining a new parameter of the biosensor based on the estimated analyte concentration and the physical characteristic of the sample; calculating an analyte concentration based on the new parameter of the biosensor and a output signal measured at the one or another of the plurality of predetermined time positions from the start of the test sequence; and annunciating the analyte concentration.
3 . A method of determining an analyte concentration from a fluid sample with a biosensor having at least two electrodes and a reagent disposed on at least one of the electrodes, the method comprising:
starting an analyte test sequence upon deposition of a sample on the biosensor; applying a signal to the sample to determine a physical characteristic of the sample; driving another signal to the sample to cause a physical transformation of the sample; measuring at least one output signal from the sample; generating a first new batch parameter of the biosensor based on the physical characteristic of the sample; calculating a first analyte concentration based on the first new batch parameter of the biosensor and an output signal measured at one of a plurality of predetermined time positions from the start of the test sequence; and annunciating the first analyte concentration.
4 . The method of claim 3 , further comprising:
generating a third parameter of the biosensor based on the physical characteristic and the first analyte concentration; calculating a third analyte concentration based on the third parameter of the biosensor a and a output signal measured at one of a plurality of predetermined time positions from the start of the test sequence; and annunciating the third analyte concentration instead of the first analyte concentration.
5 . The method of claim 3 , in which the parameter of the biosensor comprises a batch slope and the new parameter of the biosensor comprises a new batch slope.
6 . The method of claim 5 , in which the applying of the first signal and the driving of the second signal may be in sequential order.
7 . The method of claim 3 , in which the applying of the first signal overlaps with the driving of the second signal.
8 . The method of claim 3 , in which the applying of the first signal comprises directing an alternating signal to the sample so that a physical characteristic of the sample may be determined from an output of the alternating signal in which the physical characteristic comprises at least one of viscosity, hematocrit, temperature, and density of the sample, or combinations thereof.
9 . The method of claim 5 , in which the physical characteristic comprises an impedance characteristic representative of hematocrit of the sample and the analyte comprises glucose.
10 . The method of claim 9 , in which the impedance characteristic of the sample may be determined with an equation of the form:
IC= M 2 *y 1 +M*y 2 +y 3 +P 2 *y 4 +P*y 5 Eq. 4.2
where: IC represents the impedance characteristic;
M represents a magnitude |Z| of a measured impedance in ohms);
P represents a phase difference between the input and output signals (in degrees);
y 1 may be about −3.2e−08 and ±10%, 5% or 1% of the numerical value provided hereof (and depending on the frequency of the input signal, can be zero or even negative);
y 2 may be about 4.1e−03 and ±10%, 5% or 1% of the numerical value provided hereof (and depending on the frequency of the input signal, can be zero or even negative);
y 3 may be about −2.5e+01 and ±10%, 5% or 1% of the numerical value provided hereof;
y 4 may be about 1.5e−01 and ±10%, 5% or 1% of the numerical value provided hereof (and depending on the frequency of the input signal, can be zero or even negative); and
y 5 may be about 5.0 and ±10%, 5% or 1% of the numerical value provided hereof (and depending on the frequency of the input signal, can be zero or even negative).
11 . The method of claim 9 , in which the physical characteristic represented by H is generally equal to an impedance characteristic determined by an equation of the form:
IC
=
-
y
2
+
y
2
2
-
(
4
y
3
(
y
1
-
M
)
)
2
y
1
where:
IC represents the Impedance Characteristic [%]
M represents the magnitude of impedance [Ohm]
y 1 is about 1.2292e1
y 2 is about −4.3431e2
y 3 is about 3.5260e4.
12 . The method of claim 9 , in which the directing comprises driving first and second alternating signals at different respective frequencies in which a first frequency may be lower than the second frequency.
13 . The method of claim 12 , in which the first frequency may be at least one order of magnitude lower than the second frequency.
14 . The method of claim 13 , in which the first frequency comprises any frequency in the range of about 10 kHz to about 250 kHz.
15 . The method of claim 5 , in which the one of the plurality of predetermined time positions for measuring at least one output signal during the test sequence may be about 2.5 seconds after a start of the test sequence.
16 . The method of claim 15 , in which the one of the plurality of predetermined time positions comprises a time interval that overlaps a time point of 2.5 seconds after the start of the test sequence.
17 . The method of claim 5 , in which the other one of the plurality of predetermined time positions for measuring at least one output signal during the test sequence may be a time point of about 5 seconds after a start of the test sequence.
18 . The method of claim 5 , in which the one of the plurality of predetermined time positions comprises any time point at less than five seconds from a start of the test sequence.
19 . The method of claim 5 , in which the other one of the plurality of predetermined time positions comprises any time point at less than ten seconds from a start of the test sequence.
20 . The method of claim 19 , in which the one of the plurality of predetermined time positions comprises a time interval overlapping a time point of 2.5 seconds after the start of the test sequence and the other of the plurality of predetermined time positions comprises a time interval overlapping a time point of 5 seconds after the start of the test sequence.
21 . The method of claim 2 , in which the calculating of the estimated analyte concentration may be calculated from an equation of the form:
G
EST
=
[
I
E
-
P
1
P
2
]
where G 1 represents a first analyte concentration;
I E represents a total output signal from at least one electrode measured at the one of the plurality of predetermined time positions;
P 1 represents an intercept parameter of the biosensor in which P 1 may be about 475 nanoamps;
P 2 represents a slope parameter of the biosensor, in which P 2 may be about 9.5 nanoamps/(mg/dL).
22 . The method of claim 1 , in which the calculating of the first analyte concentration may be calculated from an equation of the form:
G
1
=
[
I
E
-
P
1
P
2
*
x
2
]
where G 1 represents a first analyte concentration;
I E represents a total output signal from at least one electrode measured at the one of the plurality of predetermined time positions;
P 1 represents an intercept parameter of the biosensor in which P 1 may be about 475 nanoamps;
P 2 represents a slope parameter of the biosensor, in which P 2 may be about 9.5 nanoamps/(mg/dL); and
x 2 represents a biosensor parametric factor based on the physical characteristic of the sample.Cited by (0)
No later patents cite this yet.
References (0)
No backward citations on record.