Method for measuring target component in erythrocyte-containing specimen

• US 8,760,178 B2
• Filed: 09/29/2010
• Issued: 06/24/2014
• Est. Priority Date: 09/30/2009
• Status: Expired due to Fees

• Current Assignee: ARKRAY, Inc
• Original Assignee: ARKRAY, Inc
• Inventors: Rippeth, John James
• Primary Examiner(s): Assouad, Patrick
• Assistant Examiner(s): MCANDREW, CHRISTOPHER P
• Application Number:
  US12/893,615
• Publication Number:
  US 20110074450A1
• Time in Patent Office: 1,364 Days
• Field of Search: 324/692
• 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 that comprises an electrode and a detecting portion, comprising the steps of:

acquiring a plurality of electrical signals derived from the target component in the erythrocyte-containing specimen with the biosensor by continuously applying a constant voltage to the electrode, thereby acquiring the plurality of electrical signals at a plurality of pre-determined time points in a single application of voltage at the detecting portion; and

determining an amount of the target component in the specimen based on the plurality of electrical signals with reference to the relationship between the amounts of the target component and the plurality of signals corresponding thereto.

2. The measurement method according to claim 1, wherein the relationship between the amounts of the target component and the 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 two pre-determined time points.

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

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

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

7. 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.

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

9. The measurement method according to claim 8, wherein the redox reaction is a reaction using an oxidoreductase and a mediator.

10. The measurement method according to claim 1, wherein the relationship between the amounts of the target component and the 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.

11. The measurement method according to claim 10, wherein

a plurality of corrected signals are determined from the plurality of electrical signals, 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.

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

13. 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), HbA1c, 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, α

1 acid glycoprotein (α

1AG), α

1 antitrypsin (α

1AT), α

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

1C/β

1A globulin (C3), β

1E globulin (C4), IgA, IgG, IgM, β

lipoprotein (β

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