Method for Measuring Target Component in Erythrocyte-Containing Specimen

• US 20110074450A1
• Filed: 09/29/2010
• Published: 03/31/2011
• Est. Priority Date: 09/30/2009
• Status: Active Grant

• Current Assignee: ARKRAY, Inc
• Original Assignee: ARKRAY, Inc
• Inventors: Rippeth, John James
• Granted Patent: US 8,760,178 B2
• Time in Patent Office: Days
• US Class Current: 324/692
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

[Object] To provide a method for measuring a target component in an erythrocyte-containing specimen with high reliability while suppressing the influence of the Ht value of the specimen.

[Solution to Problem] In the measurement method of the present invention, first, prior to measurement, a relationship between amounts of the target component and a plurality of signals corresponding thereto is provided. Then, a plurality of signals derived from the target component in the erythrocyte-containing specimen are acquired with a biosensor. With reference to the relationship, the amount of the target component in the specimen is determined based on the thus-acquired plurality of signals.

Claims

1. A method for measuring a target component in an erythrocyte-containing specimen with a biosensor, comprising the steps of:

(A) providing a relationship between amounts of the target component and a plurality of signals corresponding thereto prior to measurement;

(B) acquiring a plurality of signals derived from the target component in the erythrocyte-containing specimen with the biosensor; and

(C) determining an amount of the target component in the specimen based on the plurality of signals in the step (B) with reference to the relationship in the step (A).

2. The measurement method according to claim 1, wherein, in the step (A), the relationship between amounts of the target component and a plurality of signals corresponding thereto is provided with regard to different Ht values prior to measurement.

3. The measurement method according to claim 1, wherein the plurality of signals are signals acquired at a plurality of time points.

4. The measurement method according to claim 1, wherein the plurality of signals are signals acquired at two time points.

5. The measurement method according to claim 1, wherein the plurality of signals are signals acquired at a time interval of 1 to 20 seconds.

6. The measurement method according to claim 1, wherein the plurality of signals are signals acquired at the same detecting portion.

7. The measurement method according to claim 1, wherein the plurality of signals are signals acquired at a plurality of detecting portions.

8. The measurement method according to claim 1, wherein the plurality of signals are signals acquired at two detecting portions.

9. The measurement method according to claim 1, wherein the plurality of signals are signals acquired simultaneously at a plurality of detecting portions.

10. The measurement method according to claim 1, wherein the signals are signals that can be detected by electrochemical measurement.

11. The measurement method according to claim 1, wherein the signals are signals that can be detected by a working electrode as a detecting portion of the biosensor.

12. The measurement method according to claim 1, wherein the signals are signals that can be detected by optical measurement.

13. The measurement method according to claim 1, wherein the plurality of signals are signals acquired up until second 20, assuming that a time point at which signal generation becomes possible is second 0.

14. The measurement method according to claim 1, wherein the signals are signals based on a redox reaction with the target component.

15. The measurement method according to claim 14, wherein the redox reaction is a reaction using an oxidoreductase and a mediator.

16. The measurement method according to claim 1, wherein, in the step (A), the relationship between amounts of the target component and a plurality of signals corresponding thereto with regard to different Ht values is a regression equation determined by the step of:

(X) acquiring a plurality of signals with regard to a target component concentration series of each of standard specimens having different Ht values,

determining a correlation equation between the plurality of signals with regard to each of the standard specimens,

selecting any one of the standard specimens as a reference specimen showing a reference Ht value,

setting the correlation equation of the selected reference specimen as a reference correlation equation, and

determining a regression equation for converging the correlation equations of the respective standard specimens to the reference correlation equation.

17. The measurement method according to claim 16, wherein

in the step (C),

a plurality of corrected signals are determined from the plurality of signals in the step (B) with reference to the relationship in the step (A), and

the amount of the target component in the specimen is determined from the plurality of corrected signals with reference to a calibration equation determined by the step of:

(Y) acquiring a plurality of signals with regard to the target component concentration series of the reference specimen showing the reference Ht value, and

determining, as the calibration equation, a correlation equation between the plurality of signals and amounts of the target component in the reference specimen.

18. The measurement method according to claim 1, wherein the erythrocyte-containing specimen is whole blood.

19. The measurement method according to claim 1, wherein the target component is at least one selected from the group consisting of glucose, C-reactive protein (CRP), HbAlc, thyroid-stimulating hormone (TSH), FT3, FT4, hCG, HBs antigen, HBc antibody, HCV antibody, TY antigen, antistreptolysin O (ASO), type IV collagen, matrix metalloproteinase (MMP-3), PIVAK-II, α

1 microglobulin, β

1 microglobulin, amyloid A (SAA), elastase 1, basic fetoprotein (BFP), candida antigen, granulocyte elastase in cervical mucus, digoxin, cystatin C, factor XIII, urinary transferring, syphilis, hyaluronic acid, fibrin monomer complex (SFMC), von Willbrand factor (factor VIII antigen), protein S, rheumatoid factor (RF), IgD, al acid glycoprotein (α

1AG), al antitrypsin (α

1AT), α

2 macroglobulin, albumin (Alb), ceruloplasmin (Cp), haptoglobin (Hp), prealbumin, retinol-binding protein (RBP), β

1C/β

1A globulin (C3), PIE globulin (C4), IgA, IgG, IgM, β

lipoprotein (β

-LP), apoprotein A-I, apoprotein A-II, apoprotein B, apoprotein C-II, apoprotein apoprotein E, transferring (TO, urinary albumin, plasminogen (PLG), lipoprotein (a) (LP (a)), lactate, low density lipid, high density lipid and triglyceride.

20. A measurement device used in a method for measuring a target component in an erythrocyte-containing specimen with a biosensor, the measurement device comprising:

an acquisition unit that acquires a plurality of signals derived from the target component in the erythrocyte-containing specimen from the biosensor; and

a calculation unit that calculates an amount of the target component based on the plurality of signals acquired by the acquisition unit with reference to the relationship between amounts of the target component and a plurality of signals corresponding thereto.

21. The measurement device according to claim 20, wherein the relationship is a relationship between amounts of the target component and a plurality of signals corresponding thereto with regard to different Ht values.

22. The measurement device according to claim 20, wherein the plurality of signals are signals acquired at a plurality of time points.

23. The measurement device according to claim 20, wherein the plurality of signals are signals acquired at two time points.

24. The measurement device according to claim 20, wherein the plurality of signals are signals acquired at a time interval of 1 to 20 seconds.

25. The measurement device according to claim 20, wherein the plurality of signals are signals acquired at the same detecting portion.

26. The measurement device according to claim 20, wherein the plurality of signals are signals acquired at a plurality of detecting portions.

27. The measurement device according to claim 20, wherein the plurality of signals are signals acquired at two detecting portions.

28. The measurement device according to claim 20, wherein the plurality of signals are signals acquired simultaneously at a plurality of detecting portions.

29. The measurement device according to claim 20, wherein the signals are signals that can be detected by electrochemical measurement.

30. The measurement device according to claim 20, wherein the signals are signals that can be detected by a working electrode as a detecting portion of the biosensor.

31. The measurement device according to claim 20, wherein the signals are signals that can be detected by optical measurement.

32. The measurement device according to claim 20, wherein the plurality of signals are signals acquired up until second 20, assuming that a time point at which signal generation becomes possible is second 0.

33. The measurement device according to claim 20, wherein the signals are signals based on a redox reaction with the target component.

34. The measurement device according to claim 33, wherein the redox reaction is a reaction using an oxidoreductase and a mediator.

35. The measurement device according to claim 20, wherein the relationship is a regression equation determined by the step of:

(X) acquiring a plurality of signals with regard to a target component concentration series of each of standard specimens having different Ht values,

determining a correlation equation between the plurality of signals with regard to each of the standard specimens,

selecting any one of the standard specimens as a reference specimen showing a reference Ht value,

setting the correlation equation of the selected reference specimen as a reference correlation equation, and

determining a regression equation for converging the correlation equations of the respective standard specimens to the reference correlation equation.

36. The measurement device according to claim 35, wherein the calculation unit comprises:

a correction section that calculates a plurality of corrected signals based on the plurality of signals acquired by the acquisition unit with reference to the relationship; and

a calculation section that calculates the amount of the target component in the specimen with reference to, as a calibration equation, a correlation equation between the plurality of signals acquired with regard to the target component concentration series of the reference specimen showing the reference Ht value and amounts of the target component in the reference specimen.