Systems, devices, and methods for measuring whole blood hematocrit based on initial fill velocity

• US 9,927,388 B2
• Filed: 10/10/2014
• Issued: 03/27/2018
• Est. Priority Date: 12/30/2009
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Chatelier, Ronald C., Rylatt, Dennis, Raineri, Linda, Hodges, Alastair M.
• Primary Examiner(s): Van, Luan V
• Assistant Examiner(s): Rosenwald, Steven E
• Application Number:
  US14/511,235
• Publication Number:
  US 20150027907A1
• Time in Patent Office: 1,264 Days
• Field of Search: None
• CPC Class Codes: G01N 2333/4737 C-reactive protein
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01N 27/48 using polarography, i.e. measuring changes in current under a slowly-varying voltage
• CPC Class Codes: G01N 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80
• CPC Class Codes: G01N 33/80 involving blood groups or blood types or red blood cells white blood cells G01N33/56972

Abstract

Methods for determining the hematocrit of a blood sample, and devices and systems used in conjunction with the same. The hematocrit value can be determined on its own, and further, it can be further used to determine a concentration of an analyte in a sample. In one exemplary embodiment of a method for determining the hematocrit value in a blood sample, a volume of blood is provided in a sample analyzing device having a working and a counter electrode. An electric potential is applied between the electrodes and an initial fill velocity of the sample into the device is calculated. The hematocrit of the blood, as well as a concentration of an analyte in view of the initial fill velocity can then be determined. Systems and devices that take advantage of the use of an initial fill velocity to determine hematocrit levels and make analyte concentration determinations are also provided.

Claims

1. An electrochemical system, comprising:

an immunosensor having a lower electrode and an upper electrode;

a separator disposed between the lower and upper electrodes;

a detection chamber formed in the separator;

a reaction chamber;

a fill chamber formed at least partially in the separator and one of the lower and upper electrodes, spaced a distance apart from the detection chamber, and overlapping at least a portion of the reaction chamber;

a vent formed at least partially in each of the separator, the lower electrode, and the upper electrode, spaced a distance apart from the reaction chamber, and overlapping at least a portion of the detection chamber;

at least one sealing component having an incorporated anticoagulant coupled to one of the lower and upper electrodes, disposed over the vent, and configured to form a wall of the fill chamber and seal the vent;

a meter configured to apply a potential between the lower electrode and the upper electrode of the immunosensor; and

a control unit connected to the meter so that the control unit measures an initial fill velocity of a sample introduced into the immunosensor and uses the initial fill velocity to calculate at least one of a value of hematocrit of the sample when the sample is blood and a concentration of an analyte in the sample;

wherein the at least one sealing component comprises a hydrophilic adhesive tape.

2. The electrochemical system of claim 1, further comprises a heating element configured to heat at least a portion of the immunosensor.

3. The electrochemical system of claim 2, wherein the immunosensor further comprises:

a first liquid reagent comprising an antibody conjugated to an enzyme in a buffer, the first liquid reagent being striped on the lower electrode and dried;

a second liquid reagent comprising ferricyanide, a substrate for the enzyme, and a mediator in a dilute acid solution, the second liquid reagent being striped on the lower electrode and dried;

magnetic beads conjugated to an antigen, the magnetic beads being striped on the upper electrode and dried thereon;

wherein the reaction chamber is formed in the separator and is at least partially bound by the lower and upper electrodes, wherein the first liquid reagent and the magnetic beads conjugated to the antigen are at least partially disposed therein.

4. The electrochemical system of claim 1, wherein the control unit further comprises an optical signal detector configured to measure a rate of change in an optical signal to measure the initial fill velocity of the sample.

5. The electrochemical system of claim 1, wherein the control unit further comprises a current flow detector configured to measure an initial current flow to measure the initial fill velocity.

6. The electrochemical system of claim 1, wherein the control unit includes a configuration to measure the initial fill velocity of the sample directly after the sample enters a capillary space of the immunosensor.

7. The electrochemical system of claim 1, wherein the control unit includes a configuration to measure an initial fill velocity of the sample after the sample crosses into a region of a capillary space of the immunosensor where a detection signal is generated.

8. The electrochemical system of claim 3, wherein at least one of the immunosensor, the meter, and the control unit are configured to perform at least one of the following functions:

measure a temperature of the sample or infer a temperature of the sample.