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

• US 8,510,067 B2
• Filed: 09/15/2008
• Issued: 08/13/2013
• 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): KUNDU, SUJOY K
• Application Number:
  US12/210,700
• Publication Number:
  US 20090119047A1
• Time in Patent Office: 1,793 Days
• Field of Search: 702/81, 702/83, 702/84, 702/104, 374/104, 374/106, 374/150
• US Class Current: 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 performing quality assurance of a quantitative physiological sample test system without using a quality control sample, comprising:

a sample testing cartridge comprising;

a port configured to receive a physiological sample; and

a sensor configured to detect an analyte in the physiological sample;

a reader comprising;

a port configured to receive the sample testing cartridge; and

a processor configured to;

receive a signal from the sensor when the sample testing cartridge is received by the port of the reader; and

generate test results based on the signal;

a thermal and temporal stress monitor module configured to;

monitor thermal and temporal stress of the sample testing cartridge;

register a shift in baseline calibration potential of at least one sensor based on the monitored thermal and temporal stress; and

communicate information regarding the shift in the baseline calibration potential when the sample testing cartridge is received by the port of the reader; and

a quality assurance failure alert module in communication with the thermal and temporal stress monitor module and configured to;

receive the information regarding the shift in the baseline calibration potential;

compare the information against an anticipated range;

generate alert information indicating that the sample testing cartridge has failed quality assurance when the information is outside of the anticipated range; and

suppress display of the test results on the reader when the sample testing cartridge has failed quality assurance.

2. The system of claim 1, wherein the physiological sample comprises one of blood, plasma, serum, saliva, urine, cerebrospinal fluid, and amended forms thereof.

3. The system of claim 1, wherein the quality control sample comprises a liquid control.

4. The system of claim 1, wherein the sample testing cartridge is used with the test system when the information is not outside of the anticipated range.

5. The system of claim 1, wherein the thermal and temporal stress monitor module is separate from the test system and in a substantially same thermal environment as the test system.

6. The system of claim 1, wherein the thermal and temporal stress monitor module is integrated with the test system.

7. The system of claim 1, wherein the thermal and temporal stress monitor module is further configured to monitor a temperature-time indicator associated with the sample testing cartridge.

8. The system of claim 1, wherein the test system comprises a blood analysis system.

9. The system of claim 8, wherein the blood analysis system comprises the reader.

10. The system of claim 1, wherein the sample testing cartridge comprises a blood testing cartridge.

11. The system of claim 10, wherein the blood testing cartridge comprises a single-use blood testing cartridge.

12. The system of claim 10, wherein the blood testing cartridge includes at least one electrochemical sensor.

13. The system of claim 1, wherein the sample testing cartridge comprises the at least one sensor.

14. The system of claim 1, wherein the sample testing cartridge comprises one of an electrochemical sensor, an optical sensor, a luminescence sensor, a fluorescence sensor, an amperometric sensor, a potentiometric sensor, a conductimetric sensor, a wave guide, an evanescence sensor, a biosensor, a surface plasmon resonance sensor, an acoustic wave sensor, and a reflectance sensor.

15. The system of claim 1, wherein the sample testing cartridge is stored in a refrigerated enclosure below a predetermined temperature.

16. The system of claim 15, wherein the sample testing cartridge is removed from the refrigerated enclosure prior to use with the test system, and

wherein the sample testing cartridge is allowed to attain ambient temperature prior to being used with the test system.

17. The system of claim 1, wherein the test system is configured to perform a test to determine the analyte.

18. The system of claim 17, wherein the analyte comprises one of sodium, potassium, chloride, calcium, glucose, lactate, creatinine, urea, hematocrit, prothrombin time, activated clotting time, activated partial thromboplastin time, troponin I, troponin T, creatine kinase MB, brain natriuretic peptide, NTproBNP, C-reactive protein, pO2, PCO2, and pH.

19. The system of claim 1, wherein the sample testing cartridge is associated with a batch of substantially similar sample testing cartridges, and

wherein the quality assurance failure alert module is configured to generate alert information indicating that the batch has failed quality assurance when the information is outside of the anticipated range.

20. The system of claim 1, wherein the test system is configured to perform at least one failsafe check prior to use of the sample testing cartridge.

21. The system of claim 20, wherein the failsafe check comprises at least one of verification that an ambient temperature is within a predetermined range, verification that the sample testing cartridge is not faulty, and verification that the test system is not faulty.

22. The system of claim 21, wherein the verification that the test system is not faulty comprises at least one of testing electrical integrity of an electrical connector associated with the test system, and testing operational integrity of operational amplifiers associated with the test system.

23. The system of claim 1, wherein the test system comprises:

an electronic simulator, wherein the electronic simulator is configured to simulate signals produced by the sample testing cartridge.

24. The system of claim 23, wherein the electronic simulator is configured to generate simulation signals for testing at least one of electrical integrity of an electrical connector associated with the test system and operational integrity of operational amplifiers associated with the test system.

25. The system of claim 1, wherein the test system comprises:

a display module, wherein the display module is configured to display alerts in accordance with the alert information.

26. The system of claim 1, wherein the system comprises:

a log module in communication with the quality assurance failure alert module, wherein the log module is configured to maintain a log of the thermal and temporal stress of a plurality of sample testing cartridges.

27. The system of claim 1, wherein the predetermined thermal-temporal stress threshold is generated in accordance with a total allowable error of the test system.

28. The system of claim 1, wherein the predetermined thermal-temporal stress threshold comprises a plurality of combinations of thermal stress and temporal stress.

29. The system of claim 1, wherein the predetermined thermal-temporal stress threshold comprises a predetermined temperature-time profile.

30. The system of claim 1, wherein the sample testing cartridge comprises the thermal and temporal stress monitor module, and the at least one sensor is a potentiometric sensor.