IP Library Granted Patent US 10,151,724
Granted Patent B2
US 10,151,724 · App. 14/087,473 · Granted Dec 11, 2018

Systems and methods of discriminating between a control sample and a test fluid using capacitance

Inventors: Ronald C. Chatelier (Bayswater, AU); Alastair M. Hodges (Blackburn South, AU)
Assignee: LIFESCAN IP HOLDINGS, LLC
G01N27/28C12Q1/005G01N27/3274G01N33/48707
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Quick Facts
Patent No.
US 10,151,724
App. No.
14/087,473
Filed
Nov 22, 2013
Granted
Dec 11, 2018
Kind
B2
Art Unit
1795
USPC
204/406
Abstract

Methods for distinguishing between an aqueous non-blood sample (e.g., a control solution) and a blood sample are provided herein. In one aspect, the method includes using a test strip in which multiple current transients are measured by a meter electrically connected to an electrochemical test strip. The current transients are used to determine if a sample is a blood sample or an aqueous non-blood sample based on characteristics of the sample (e.g., amount of interferent present, reaction kinetics, and/or capacitance). The method can also include calculating a discrimination criteria based upon these characteristics. Various aspects of a system for distinguishing between a blood sample and an aqueous non-blood sample are also provided herein.

Claims (38)

1. A method for distinguishing between a blood sample and an aqueous non-blood sample using a test meter, the test meter having a processor, the method comprising the steps of:

(a) using the test meter, applying a first test voltage for a first time interval, a second test voltage for a second time interval and a third test voltage for a third time interval for each of a plurality of aqueous non-blood samples applied to representative test strips, each test strip having an electrochemical cell;

(b) using the test meter, calculating a first reference value and a second reference (Y) value for the plurality of aqueous non-blood samples, in which the first reference value is determined by a summation of current values measured by the test meter during the first time interval and the second reference value is determined by a ratio of current values obtained during the second and third time intervals;

(c) using the test meter, calculating a third reference (i capsum ) value based on the first reference value, the third reference value being proportional to a capacitance index, the capacitance index (C av /C m ) comprising a ratio of a pre-determined average capacitance of electrochemical cells measured when blood samples are loaded into test strips of the same type and an estimated capacitance of the electrochemical cell when the sample is introduced (C m );

(d) using the test meter, repeating steps (a)-(c) for a plurality of blood samples applied to representative test strips, each test strip having an electrochemical cell;

(e) plotting the third reference value obtained from each of the aqueous non-blood samples and each of the blood samples on a first axis and plotting the second reference value obtained from each of the aqueous non-blood samples and each of the blood samples on a second axis and generating a discrimination line segregating the aqueous non-blood samples from the blood samples;

(f) using the test meter, storing a discrimination relation based on the plotted discrimination line as a discrimination criteria;

(g) applying an unknown sample to a test strip;

(h) loading the sample into the test meter;

(i) using the test meter, applying the first test voltage for the first time interval, the second test voltage for the second time interval and the third test voltage for the third time interval;

(j) measuring the capacitance of the unknown sample during the second time interval;

(k) determining the capacitance index of the unknown sample; and

(l) calculating the first reference value, the second reference value and the third reference value for the unknown sample and using the stored discrimination criteria to distinguish whether the unknown sample is a blood sample or an aqueous non-blood sample.

2. The method of claim 1 , wherein the first reference value is representative of antioxidant concentration and the second reference value is representative of reaction kinetics.

3. The method of claim 1 , wherein the plurality of aqueous non-blood samples comprise a plurality of control solutions.

4. The method of claim 1 , wherein the discrimination criteria is applied as follows:

If

i

capsum

12

and

Y

<

Z

icapsum

-

12

icapsum

,

 then sample is blood, else the applied sample is an aqueous non-blood sample, in which Z is a constant of about 0.2.

5. The method of claim 1 , in which the first, second and third test voltages are DC voltages and in which the capacitance of the electrochemical cell is estimated by applying an alternating AC wave during the second time interval with the second test voltage, and either summing the test current over one quarter of the alternating AC wave on either side of the zero crossing point or summing the test currents on either side of the maximum AC component of the current.

Assignments (16)
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 →
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: 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, FSB
To: LIFESCAN IP HOLDINGS, LLC
Reel/Frame 073929/0316 →
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 →
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 →
RELEASE OF SECOND LIEN PATENT SECURITY AGREEMENT RECORDED OCT. 3, 2018, REEL/FRAME 047186/0836 Recorded Jun 28, 2023
From: BANK OF AMERICA, N.A.
To: LIFESCAN IP HOLDINGS, LLC; JANSSEN BIOTECH, INC.; JOHNSON & JOHNSON CONSUMER INC.
Reel/Frame 064206/0176 →
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 Nov 19, 2019
From: CILAG GMBH INTERNATIONAL
To: LIFESCAN IP HOLDINGS, LLC
Reel/Frame 051050/0413 →
SECURITY AGREEMENT Recorded Oct 3, 2018
From: LIFESCAN IP HOLDINGS, LLC
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 047186/0836 →
SECURITY AGREEMENT Recorded Oct 2, 2018
From: LIFESCAN IP HOLDINGS, LLC
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 047179/0150 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 17, 2018
From: CHATELIER, RONALD C.; HODGES, ALASTAIR M.
To: CILAG GMBH INTERNATIONAL
Reel/Frame 044640/0021 →
Continuity (2)
Division 12895067 · Sep 30, 2010
Related Publication 20140151244A1 · Jun 5, 2014