PATIENT SERUM/PLASMA SAMPLE RESISTIVITY FOR ELECTROLYTE RESULT VERIFICATION

• US 20150008122A1
• Filed: 08/24/2012
• Published: 01/08/2015
• Est. Priority Date: 09/13/2011
• Status: Active Grant

• Current Assignee: Siemens Healthcare Diagnostics Incorporated (Siemens AG)
• Original Assignee: Siemens Healthcare Diagnostics Incorporated (Siemens AG)
• Inventors: Thompson, David R.
• Granted Patent: US 9,228,975 B2
• Time in Patent Office: Days
• US Class Current: 204/403.01
• CPC Class Codes: G01N 27/06 of a liquid involving electrolysis G01N27/26
• CPC Class Codes: G01N 27/416 Systems G01N27/27 takes precedence
• CPC Class Codes: G01N 27/4166 measuring a particular property of an electrolyte
• 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

Abstract

Verification of patient sample electrolyte results using a separate quantitative measurement of sample resistivity. Sample resistivity may be used to measure small differences in resistivity of one sample to the next, and in comparison to a standard solution, in order to verify the results of sample electrolyte measurements being measured at the same time by, for example, individual ion selective electrodes (ISE) in a clinical analyzer. Providing a separate or secondary quantitative means for verification of the measured results of sample electrolytes using sample resistivity solves the problem of electrolyte result variability in sample electrolyte measurements. The process may compare a measured sample resistivity to an expected resistivity value as a verification of the accuracy of individual electrolyte results. Suspect samples—e.g., where the electrolyte resistivity results do not fit the expected resistivity—may be flagged. This separate verification step provides added confidence in the measured electrolyte results and can identify when problems occur or interferences are present in real time.

Claims

1. A sample resistivity measurement system for sample electrolyte result verification comprising:

a sample cartridge for performing sample electrolyte measurements, said sample cartridge comprising;

one or more ion selective electrodes;

a common reference electrode to provide a constant reference potential;

a circuit connecting each of said one or more ion selective electrodes with said reference electrode;

an electrometer connected to said circuit to measure a potential of said one or more ion selective electrodes against said reference electrode;

wherein concentrations of desired ions are calculated from an electrode voltage difference between a sample having unknown ion concentration and unknown resistivity and a standard solution having known ion concentration and known resistivity to obtain a measured sample electrolyte result, wherein said sample and said standard solution are run alternately in series through said sample cartridge;

a measured sample resistivity of said sample;

a measured sample resistivity of said standard solution used to establish a response slope for said one or more ion-selective electrodes and to provide a reference point against which said sample is compared;

a resistivity ratio calculated from said measured sample resistivity of said sample and said measured sample resistivity of said standard solution;

historical data comprising one or more of;

measured sample electrolyte concentrations, and measured sample resistivities;

an expected sample resistivity response developed from said historical data; and

a tolerance about said expected sample resistivity response, wherein said measured sample electrolyte result is verified to be an acceptable result if said measured sample resistivity falls within said tolerance about said expected sample resistivity response.

2. The system of claim 1, further comprising a flag triggered when said measured sample resistivity falls outside said tolerance.

3. The system of claim 1, wherein said system provides a separate and quantitative means for verification of measured sample electrolyte results of an electrolyte measuring module on a clinical chemistry analyzer.

4. The system of claim 1, wherein said system performs said sample resistivity measurement on each sample run through said sample cartridge to detect errors in individual electrolyte result calculations.

5. The system of claim 1, further comprising:

an integrated multi-sensor technology (IMT) comprising said ion selective electrodes (ISE), wherein said sample cartridge is inserted in said IMT for receipt and measurement of said sample and said standard solution;

a database storing said historical data of measured sample electrolyte concentrations; and

a processor connected to said IMT to perform said calculation of ion concentration and connected to said database to determine whether said measured sample resistivity falls within said tolerance.

6. The system of claim 1, wherein a relationship between electrolyte concentration and resistivity ratio is represented by a ratio of said measured sample resistivity over said measured standard solution resistivity, which provides a power relationship between electrolyte concentration and resistivity.

7. The system of claim 1, wherein a relationship between electrolyte concentration and resistivity ratio is represented by a ratio of said measured standard solution resistivity over said measured sample resistivity, which provides a linear relationship between electrolyte concentration and resistivity.

8. The system of claim 7, wherein the relationship is compared against a first constant, wherein if the relationship is greater than the first constant, the measured sample resistivity comprises a measurement error, and wherein if the relationship is greater than or equal to the first constant, the measured sample resistivity comprises a good result.

9. The system of claim 8, wherein the relationship is compared against a second constant, wherein if the relationship is greater than the second constant, the measured sample resistivity comprises a measurement error, and wherein if the relationship is greater than or equal to the second constant, the measured sample resistivity comprises a good result.

10. The system of claim 9, wherein the relationship further comprises a function of a concentration of one or more of sodium (Na), potassium (K), and chlorine (Cl).

11. The system of claim 1, wherein said tolerance further comprises an upper limit and a lower limit determined from said historical data.

12. The system of claim 1, further comprising a plot comprising:

an x-axis comprising a summation of ions;

a y-axis comprising said resistivity ratio of said resistivity measurements;

an expected sample resistivity response curve plotted using said expected sample resistivity response;

a tolerance curve plotted using said tolerance, said tolerance curve plotted about said expected sample resistivity response curve; and

measured sample resistivity points, said measured sample resistivity points plotted on said plot relative to said expected sample resistivity response curve and said tolerance curve.

13. The system of claim 1, wherein said one or more ion-selective electrodes further comprise one or more of:

a sodium (Na) electrode, a potassium (K) electrode, and a chlorine (Cl) electrode;

for measuring said one or more desired ions comprising;

sodium (Na), potassium (K), and chlorine (Cl), respectively.

14. The system of claim 1, wherein said sample comprises patient serum and plasma samples and includes a measurement of:

sodium (Na) ions and potassium (K) ions;

to verify an electrolyte measurement of sodium (Na) and potassium (K).

15. The system of claim 1, wherein said sample comprises patient serum and plasma samples and includes a measurement of:

sodium (Na) ions, potassium (K) ions, and chlorine (Cl) ions;

to verify an electrolyte measurement of sodium (Na), potassium (K), and chlorine (Cl).

16. The system of claim 1, wherein said sample comprises patient serum and plasma samples and includes a measurement of:

sodium (Na) ions and potassium (K) ions; and

sodium (Na) ions, potassium (K) ions, chlorine (Cl) ions;

to isolate and verify an electrolyte measurement of chlorine (Cl).

17. A method for using patient sample resistivity for patient sample electrolyte result verification, said method comprising:

running a patient sample having an unknown resistivity and measuring a resistivity of said patient sample;

running a standard solution having a known resistivity and measuring a resistivity of said standard solution to provide a reference point against which said patient sample may be compared;

calculating a resistivity ratio comprising said measured patient sample resistivity over said measured standard solution resistivity;

comparing said measured patient sample resistivity to an expected resistivity derived from historical data of previously measured patient sample resistivity; and

flagging said unknown patient sample if said measured unknown patient sample resistivity does not fall within a predefined tolerance about said expected resistivity.

18. A method for verifying patient sample electrolyte results using patient sample resistivity measurements, said method comprising:

providing a sensor cartridge comprising;

one or more ion-selective electrodes;

a common reference electrode to provide a constant reference potential;

a circuit connecting each of said one or more ion-selective electrodes with said reference electrode;

an electrometer connected to said circuit to measure a potential of said one or more ion-selective electrodes against said reference electrode;

running a patient sample through said sensor cartridge;

measuring a concentration of a desired ion in said patient sample using one or more ion-selective electrodes;

measuring a resistivity of said patient sample using an electrometer connected to said circuit connecting said one or more ion-selective electrodes and said reference electrode, wherein said electrometer measures a potential of said one or more ion-selective electrodes against said reference electrode;

running a standard solution through said sensor cartridge;

measuring a concentration of said desired ion in said standard solution using said one or more ion-selective electrodes;

measuring a resistivity of said standard solution to calibrate a slope response of said one or more ion-selective electrodes and to provide a reference point against which said patient sample is compared;

calculating a concentration of said desired ion from said comparison said measured concentration of said desired ion in said patient sample and said measured concentration of said desired ion in said standard solution;

calculating a resistivity ratio comprising said measured patient sample resistivity divided by said measured standard solution resistivity;

comparing said measured patient sample resistivity to an expected resistivity developed from historical resistivity measurements of other patient samples; and

flagging said measured patient sample if said measured patient sample resistivity does not fall within a predefined tolerance about said expected resistivity.

19. The method of claim 18, further comprising:

plotting a summation of ions along an x-axis and said resistivity ratio along a y-axis;

plotting an expected sample resistivity response curve comprising said historical resistivity measurements;

plotting a tolerance curve using said predefined tolerance, said tolerance curve plotted about said expected sample resistivity response curve; and

plotting said measured sample resistivity relative to said expected sample resistivity response curve and said tolerance curve.

20. The method of claim 18, wherein said patient sample comprises patient serum and plasma samples, and wherein said desired ion comprises one or more of:

sodium (Na), potassium (K), and chlorine (Cl);

to verify an electrolyte measurement of sodium (Na), potassium (K), and chlorine (Cl).

21. The method of claim 18, wherein said patient sample comprises patient serum and plasma samples, and wherein said desired ion comprises one or more of:

sodium (Na) ions and potassium (K) ions;

to verify an electrolyte measurement of sodium (Na) and potassium (K).

22. The method of claim 18, wherein said patient sample comprises patient serum and plasma samples, and wherein said desired ion comprises one or more of:

sodium (Na) ions, potassium (K) ions, and chlorine (Cl) ions;

to verify an electrolyte measurement of sodium (Na), potassium (K), and chlorine (Cl).

23. The method of claim 18, wherein said patient sample comprises patient serum and plasma samples, and wherein said desired ion comprises one or more of:

sodium (Na) ions and potassium (K) ions; and

sodium (Na) ions, potassium (K) ions, chlorine (Cl) ions;

to isolate and verify an electrolyte measurement of chlorine (Cl).