IP Library Granted Patent US 11,733,198
Granted Patent B2
US 11,733,198 · App. 17/346,765 · Granted Aug 22, 2023

Method for determining analyte concentration in a sample

Inventors: Zuifang Liu (Inverness, GB); David McColl (Inverness, GB); Robert Donald (Inverness, GB); Anna Salgado (Inverness, GB); Antony Smith (Inverness, GB)
Assignee: LIFESCAN IP HOLDINGS, LLC
G01N27/3274G01N27/3273A61B5/14532A61B2562/0295G01N27/3272G01N27/3277G01N27/4168G01N27/48
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Quick Facts
Patent No.
US 11,733,198
App. No.
17/346,765
Filed
Jun 14, 2021
Granted
Aug 22, 2023
Kind
B2
Art Unit
1759
USPC
205/777.5
Abstract

A method for determining a concentration of an analyte in a fluidic sample is described. A sample is applied to a biosensor including an electrochemical cell having electrodes. A predetermined voltage waveform is applied during at least first and second time intervals. At least first and second current values are measured during the first and second time intervals, respectively. A turning point time is determined during the first time interval at which the measured first current values transition from a first to a second profile. The concentration of analyte in the sample is calculated based on determined turning point time and at least one measured current value. In another example, a physical characteristic of the sample is estimated based on measured current values. The concentration is calculated using a first or second model if the estimated physical characteristic of the sample is in a first or second range, respectively.

Claims (66)

1. A method for determining a concentration of an analyte in a fluidic sample, the method comprising:

applying the fluidic sample to a biosensor, the biosensor comprising an electrochemical cell having electrodes;

applying a voltage waveform comprising at least a first predetermined voltage applied during a first time interval and a second predetermined voltage different from the first predetermined voltage applied during a second time interval;

measuring at least first current values during the first time interval and second current values during the second time interval;

determining a turning point time during the first time interval at which the measured first current values transition from a first profile to a second profile; and

estimating a physical characteristic of the sample based on the turning point time, the first measured current values and the second measured current values;

if the estimated physical characteristic of the sample is in a first range, calculating the concentration of the analyte in the sample using a first model based on the first measured current values and the second measured current values; and

if the estimated physical characteristic of the sample is in a second range, calculating the concentration of the analyte in the sample using a second model based on the determined turning point time, the first measured current values and second measured current values.

2. The method of claim 1 , wherein the first model comprises first coefficients and the second model comprises second coefficients, and the first coefficients and the second coefficients are determined by linear optimization.

3. The method of claim 1 , wherein the physical characteristic is the hematocrit level of the fluidic sample.

4. The method of claim 2 , wherein the voltage waveform further comprises a third predetermined voltage applied during a third time interval, the method further comprising measuring third current values during the third time interval.

5. The method of claim 4 , wherein calculating the analyte concentration using the first model comprises using an equation of the form G basic 1 =(a 1 ·|i 2corr |−z gr 1 ), and calculating the analyte concentration using the second model comprises using an equation of the form:

G basic 2 =( a 2 ·|i 2corr |−z gr 2 ), in which:

G basic 1 is the analyte concentration calculated using the first model (in mg/dL);

a 1 and z gr 1 are first model predetermined coefficients;

G basic 2 is the analyte concentration calculated using the second model (in mg/dL);

a 2 and z gr 2 are second model predetermined coefficients;

i

2

corr

=

+

b

-

c

+

b

·

i

r

(

in

microamperes

)

;

i pc is close to a negative peak of the third current values in the third time interval (in microamperes);

i pb is close to a peak of the second current values in the second time interval (in microamperes);

i ss is a steady state of the third current values in the third time interval;

i r is a sum of at least some of the measured third current values of the third time interval (in microamperes); and

b, c and p are predetermined coefficients.

6. The method of claim 1 , wherein the biosensor comprising the electrochemical cell has at least two electrodes.

7. The method of claim 6 , wherein the at least two electrodes of the electrochemical cell are disposed either cofacially or coplanar relative to one another.

8. The method of claim 7 , wherein the at least two electrodes of the electrochemical cell comprise a bare electrode and an at least partially reagent covered electrode.

9. The method of claim 1 , wherein the measuring of the first and second current values is at a frequency between 50-200 Hz.

10. The method of claim 1 , wherein the measured first current values transition from the first profile to the second profile due to the presence of an interferent in the sample.

11. The method of claim 10 , wherein a current i pb representative of a transition from a first predetermined voltage of the waveform during the first time interval and a second predetermined voltage of the waveform during the second time interval occurs during an initial portion of the second time interval.

12. The method of claim 11 , wherein the turning point time occurs prior to the occurrence of i pb .

13. The method of claim 10 , wherein the interferent comprises uric acid or ascorbic acid.

14. The method of claim 1 , wherein the first profile deviates from a Cottrell profile and the second profile follows a Cottrell profile.

Assignments (13)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 18, 2026
From: LIFESCAN GLOBAL CORPORATION; LIFESCAN CHINA, LLC; LIFESCAN IP HOLDINGS, LLC
To: LIFESCAN ENTERPRISES LLC
Reel/Frame 075848/0012 →
RELEASE OF SECURITY INTEREST Recorded Dec 8, 2025
From: ANKURA TRUST COMPANY, LLC
To: LIFESCAN IP HOLDINGS, LLC
Reel/Frame 073929/0495 →
SECURITY INTEREST Recorded Dec 8, 2025
From: LIFESCAN ENTERPRISES LLC
To: ACQUIOM AGENCY SERVICES LLC, AS COLLATERAL AGENT
Reel/Frame 073890/0305 →
RELEASE OF SECURITY INTEREST Recorded Dec 8, 2025
From: WILMINGTON SAVINGS FUND SOCIETY, FSBWILMINGTON SAVINGS FUND SOCIETY, FSB
To: LIFESCAN IP HOLDINGS, LLC
Reel/Frame 073928/0626 →
SECURITY AGREEMENT Recorded Dec 8, 2025
From: LIFESCAN ENTERPRISES LLC
To: WELLS FARGO BANK, NATIONAL ASSOCIATION
Reel/Frame 073893/0622 →
RELEASE OF SECURITY INTEREST Recorded Dec 8, 2025
From: WILMINGTON SAVINGS FUND SOCIETY, FSB
To: LIFESCAN IP HOLDINGS, LLC
Reel/Frame 073929/0316 →
ASSIGNMENT OF PATENT SECURITY INTERESTS (1ST LIEN) Recorded Aug 22, 2025
From: BANK OF AMERICA, N.A.
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SUCCESSOR AGENT
Reel/Frame 072567/0482 →
PATENT SECURITY AGREEMENT Recorded Jan 13, 2025
From: LIFESCAN IP HOLDINGS, LLC
To: ANKURA TRUST COMPANY, LLC, AS COLLATERAL AGENT
Reel/Frame 069881/0018 →
TRANSFER OF SECURITY AGREEMENT RECORDED AT REEL 063740, FRAME 0080 Recorded Nov 12, 2024
From: BANK OF AMERICA, N.A., AS RESIGNING AGENT
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SUCCESSOR AGENT
Reel/Frame 069340/0243 →
SECOND LIEN PATENT SECURITY AGREEMENT Recorded May 23, 2023
From: LIFESCAN IP HOLDINGS, LLC
To: BANK OF AMERICA, N.A.
Reel/Frame 063740/0080 →
FIRST LIEN PATENT SECURITY AGREEMENT Recorded May 22, 2023
From: LIFESCAN IP HOLDINGS, LLC
To: BANK OF AMERICA, N.A.
Reel/Frame 063712/0430 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 1, 2023
From: LIU, ZUIFANG; MCCOLL, DAVID; DONALD, ROBERT; SALGADO, ANNA; SMITH, ANTONY
To: CILAG GMBH INTERNATIONAL
Reel/Frame 062836/0361 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 1, 2023
From: CILAG GMBH INTERNATIONAL
To: LIFESCAN IP HOLDINGS, LLC
Reel/Frame 062836/0606 →
Continuity (2)
Division 16021403 · Jun 28, 2018
Related Publication 20210381998A1 · Dec 9, 2021