Quality assurance system and method for point-of-care testing

• US 9,772,302 B2
• Filed: 06/28/2013
• Issued: 09/26/2017
• Est. Priority Date: 09/13/2007
• Status: Active Grant

• Current Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Zelin, Michael P., Brouwer, Eric, Breeze, Steven
• Primary Examiner(s): Le, Toan
• Assistant Examiner(s): SUN, XIUQIN
• Application Number:
  US13/930,299
• Publication Number:
  US 20130292246A1
• Time in Patent Office: 1,551 Days
• Field of Search: 702 84
• CPC Class Codes: G01K 3/04 in respect of time
• CPC Class Codes: G01N 2035/00089 Magazines
• 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 27/4163 checking the operation of, or calibrating, the measuring apparatus G01N27/3274, G01N27/4175 and G01N33/0006 take precedence
• CPC Class Codes: G01N 31/229 for investigating time/temperature history

Abstract

An improved quality assurance system and method for point-of-care testing are disclosed. The present invention provides quality assurance for laboratory quality tests performed by a blood analysis system or the like at the point of patient care without the need for running liquid-based quality control materials on the analysis system. Quality assurance of a quantitative physiological sample test system is performed without using a quality control sample by monitoring the thermal and temporal stress of a component used with the test system. Alert information is generated that indicates that the component has failed quality assurance when the thermal and temporal stress exceeds a predetermined thermal-temporal stress threshold. Alternatively, the present invention provides quality assurance for laboratory quality tests performed by a blood analysis system or the like at the point of patient care by minimizing the need for running liquid-based quality control materials on the analysis system.

Claims

1. A system for thermal and temporal stress quality assurance of a quantitative electrochemical physiological sample test system, comprising:

a plurality of electrochemical sensors,

wherein the plurality of electrochemical sensors comprises a subset of the plurality of electrochemical sensors contacted with a calibrant fluid having known concentrations of analytes, to which each sensor of the subset of electrochemical sensors is specific,

and wherein the subset of electrochemical sensors generates transient electrical signals upon being contacted, wetting up and equilibrating with the calibrant fluid; and

a calibration circuit in communication with the subset of electrochemical sensors,

wherein the calibration circuit is configured, upon obtaining the transient electrical signals from the subset of electrochemical sensors, to determine a calibration parameter associated with a concentration of an analyte in the calibrant fluid for each electrochemical sensor of the subset of electrochemical sensors, to compare the calibration parameter to a predetermined check threshold stored in the system and to determine whether the calibration parameter exceeds the predetermined check threshold using a computer algorithm embedded within software used to operate the system, wherein a determination that the calibration parameter exceeds the predetermined check threshold is indicative that an electrochemical sensor was exposed temporally to thermal stress,

wherein the calibration circuit is configured to generate alert information disqualifying the entire test system from performing a physiological sample test when the predetermined check threshold is exceeded for each electrochemical sensor of the subset of the electrochemical sensors, which is indicative of incorrect storage conditions of the quantitative electrochemical physiological sample test system;

and wherein the calibration parameter comprises;

a calibration voltage that is a difference between a voltage generated by each electrochemical sensor of the subset of electrochemical sensors and a corresponding reference electrode;

a calibration voltage drift rate associated with the wetting-up of each electrochemical sensor of the subset of electrochemical sensors;

or,

a combination of said calibration voltage and said calibration voltage drift rate.

2. The system of claim 1, wherein the subset of electrochemical sensors comprises a calcium ion-selective electrode and a BUN electrode.

3. The system of claim 1, wherein the subset of electrochemical sensors comprises a sodium ion-selective electrode, a calcium ion-selective electrode, and a BUN electrode.

4. The system of claim 1, wherein the plurality of electrochemical sensors comprises one of a sodium sensor, a potassium sensor, a chloride sensor, a pH sensor, a pO₂-sensor, a pCO₂ sensor, a lactate sensor, a glucose sensor, a creatinine sensor, a BUN electrode, a calcium sensor, a magnesium sensor, and a hematocrit sensor.

5. The system of claim 1, wherein the subset of electrochemical sensors of the plurality of electrochemical sensors is configured to determine the thermal and temporal stress for all of the plurality of electrochemical sensors, and when the predetermined check threshold is exceeded for each electrochemical sensor of the subset of the electrochemical sensors, it is indicative that all of the plurality of the electrochemical sensors was exposed temporally to thermal stress.

6. The system of claim 1, wherein the system is configured to display an alert when the alert information is generated.

7. The system of claim 1, further comprising a display module in communication with the calibration circuit, the display module configured to display an alert when the alert information is generated.

8. The system of claim 1, wherein the system is configured to suppress display of test results, when the alert information is generated.

9. A system for evaluating thermal and temporal stress quality assurance of a quantitative electrochemical physiological sample test system, the system comprising:

a plurality of electrochemical sensors configured to perform a plurality of quantitative electrochemical physiological sample tests, wherein the plurality of electrochemical sensors includes a subset of electrochemical sensors that are further configured to determine the thermal and temporal stress for all of the plurality of electrochemical sensors, the subset of electrochemical sensors including a first electrochemical sensor and a second electrochemical sensor, wherein the subset of electrochemical sensors generates transient electrical signals upon being contacted, wetting up and equilibrating with a calibrant fluid;

a thermal and temporal stress monitor module configured to;

(i) determine a first calibration voltage for the first electrochemical sensor upon obtaining a transient electrical signal from the first electrochemical sensor, wherein the first calibration voltage is a difference between a voltage generated by the first electrochemical sensor and a first reference electrode, is associated with a concentration of a first analyte in the calibrant fluid, and a rate of change in the concentration of the first analyte is a function of temperature, and

(ii) determine a second calibration voltage for the second electrochemical sensor upon obtaining a transient electrical signal from the second electrochemical sensor, wherein the second calibration voltage is a difference between a voltage generated by the second electrochemical sensor and a second reference electrode, same or different as the first reference electrode, is associated with a concentration of a second analyte in the calibrant fluid, and a rate of change in the concentration of the second analyte is a function of temperature,

a quality assurance failure alert module configured to

(i) receive the first calibration voltage from the thermal and temporal stress monitor module and determine whether the first calibration voltage exceeds a first check threshold, using a computer algorithm embedded within software used to operate the system, wherein a determination that the first calibration voltage exceeds the first check threshold is indicative that the first electrochemical sensor was exposed temporally to thermal stress,

(ii) receive the second calibration voltage from the thermal and temporal stress monitor module and determine whether the second calibration voltage exceeds a second check threshold, using the computer algorithm embedded within software used to operate the system, wherein a determination that the second calibration voltage exceeds the second check threshold is indicative that the second electrochemical sensor was exposed temporally to thermal stress, and

(iii) generate alert information disqualifying all of the plurality of electrochemical sensors from performing the plurality of quantitative electrochemical physiological sample tests when the first calibration voltage exceeds the first check threshold and the second calibration voltage exceeds the second check threshold.

10. The system of claim 9, wherein the first electrochemical sensor comprises a sodium ion-selective electrode, and wherein the second electrochemical sensor comprises a calcium ion-selective electrode.

11. The system of claim 9, wherein the first sensor comprises a calcium ion-selective electrode and the second sensor comprise a BUN electrode.

12. The system of claim 9, wherein the subset of the electrochemical sensors comprises a combination of two of a sodium ion-selective electrode, a calcium ion-selective electrode, and a BUN electrode.

13. The system of claim 9, wherein the subset of the electrochemical sensors comprises a combination of two of a sodium sensor, a potassium sensor, a chloride sensor, a pH sensor, a pO₂-sensor, a pCO₂ sensor, a lactate sensor, a glucose sensor, a creatinine sensor, a BUN electrode, a calcium sensor, a magnesium sensor, and a hematocrit sensor.

14. The system of claim 9, wherein the system is configured to display an alert when the alert information is generated.

15. The system of claim 9, further comprising a display module in communication with the quality assurance failure alert module, the display module configured to display an alert when the alert information is generated.

16. The system of claim 9, wherein the system is configured to suppress display of test results, when the alert information is generated.