IP Library Granted Patent US 9,274,078
Granted Patent B2
US 9,274,078 · App. 13/924,031 · Granted Mar 1, 2016

Systems and methods of discriminating control solution from a physiological sample

Inventors: Ronald C. Chatelier (Bayswater, AU); Alastair M. Hodges (Blackburn South, AU); Maria Teodorczyk (San Jose, CA); Remedios Dato (Pleasanton, CA)
Assignee: LifeScan, Inc.
G01N27/3271C12Q1/001C12Q1/006G01N27/3274
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Quick Facts
Patent No.
US 9,274,078
App. No.
13/924,031
Granted
Mar 1, 2016
Kind
B2
Abstract

Described herein are systems and methods for distinguishing between a control solution and a blood sample. In one aspect, the methods include 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 a control solution based on at least two characteristics. Further described herein are methods for calculating a discrimination criteria based upon at least two characteristics. Still further described herein are system for distinguishing between blood samples and control solutions.

Claims (20)

1. A method for calculating a discrimination criteria for programming into a test meter for distinguishing between a blood sample and a control solution sample, the method comprising the steps of:

(a) calculating an interferent index and a residual reaction index for a plurality of control solution samples in which the interferent index is based upon summing of at least two current values measured during a first test potential and the residual reaction index is based upon a ratio of at least two current values measured during a second test potential and third test potential, respectively; and

(b) calculating a discrimination criteria based on a regression of the interferent index and the residual reaction index for the plurality of control solution samples.

2. The method of claim 1 , wherein the discrimination criteria is a discrimination line.

3. The method of claim 2 , wherein the method further comprises the step of:

plotting an interferent index and a residual reaction index for a plurality of blood samples and shifting the discrimination line towards the plurality of blood samples.

4. A method for distinguishing between a blood sample and a control solution sample, the method comprising the steps of:

(a) introducing a sample into an electrochemical cell, the electrochemical cell comprising:

(i) two electrodes in a spaced apart relationship; and

(ii) a reagent;

(b) applying a first test potential, having a first polarity, between the electrodes, and measuring cell current;

(c) summing at least two current values measured during the first test potential to generate an interferent index;

(d) using the interferent index to distinguish between a blood sample and a control solution sample.

5. The method according to claim 4 , wherein the first potential is in the range of about 1 mV and 100 mV.

6. The method according to claim 1 , further comprising the steps of:

(e) applying a second test potential, having the first polarity, between the electrodes and measuring cell current;

(f) applying a third test potential, having a second polarity opposite of the first polarity between the electrodes and measuring cell current;

(g) determining a residual reaction index based on at least one current value measured during the second and third test potentials;

(h) using the residual reaction index to distinguish between a control sample and a blood sample.

7. The method according to claim 6 , in which residual reaction index is based on a ratio of at least one current value measured during the second test potential and at least one current value measured during the third test potential.

Assignments (13)
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 →
SECURITY AGREEMENT Recorded Dec 8, 2025
From: LIFESCAN ENTERPRISES LLC
To: WELLS FARGO BANK, NATIONAL ASSOCIATION
Reel/Frame 073893/0622 →
CORRECTIVE ASSIGNMENT TO CORRECT THE PROPERTY LIST BY ADDING PATENTS 6990849;7169116; 7351770;7462265;7468125; 7572356;8093903; 8486245;8066866;AND DELETE 10881560. PREVIOUSLY RECORDED ON REEL 050836 FRAME 0737. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Aug 28, 2023
From: LIFESCAN INC.
To: CILAG GMBH INTERNATIONAL
Reel/Frame 064782/0443 →
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 Oct 28, 2019
From: CILAG GMBH INTERNATIONAL
To: LIFESCAN IP HOLDINGS, LLC
Reel/Frame 050837/0001 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 28, 2019
From: LIFESCAN INC.
To: CILAG GMBH INTERNATIONAL
Reel/Frame 050836/0737 →
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.; TEODORCZYK, MARIA; DATO, REMEDIOS
To: LIFESCAN, INC.
Reel/Frame 044639/0822 →
Continuity (2)
Division 11278333 · Mar 31, 2006
Related Publication 20140005949A1 · Jan 2, 2014