CN111239227A - Erythrocyte volume correction method and biosensor testing device - Google Patents

Abstract

The invention discloses a method for correcting hematocrit, which comprises the following steps: s1, detecting blood sample parameters of the blood sample; s2, measuring hematocrit: detecting hematocrit (HCT%) in the blood sample based on a correlation curve of a blood sample parameter to hematocrit; s3, measuring initial analyte concentration value C_{First stage}(ii) a S4, analyte concentration correction: using the measured hematocrit of blood (HCT%) and the measured initial analyte concentration value C_{First stage}Calculating the final corrected analyte concentration value C_{Final (a Chinese character of 'gan')}. The biosensor testing device with the hematocrit correction is further disclosed, and a correlation curve of the hematocrit (HCT%) and the blood sample parameter in the hematocrit correction method is programmed and input into the biosensor testing device. The invention can effectively eliminate blood red blood cellsThe influence of the packed volume on the analyte concentration measurement improves the accuracy of the detection.

Description

A kind of hematocrit correction method and biosensor testing device

technical field

The invention belongs to the field of biosensing, and relates to a hematocrit correction method and a biosensor testing device applying the hematocrit correction method.

Background technique

Biosensors have been widely used in the fields of medical testing, environmental analysis and food testing. Electrochemical biosensors chemically react with the analyte to be measured in a certain way, and convert the reaction signal into an electrical signal that can be analyzed and measured. A technique for qualitative or quantitative analysis of analytes. This type of sensor has the characteristics of simple operation, small sample volume, high accuracy, low manufacturing cost, and can be used for real-time detection. , thereby interfering with the test analyte concentration results. Most of the existing hematocrit testing methods utilize blood flow rate method, conductometric method or impedance method, and correct the analyte concentration. These methods are greatly affected by the stability of the sensor printed electrodes and the material properties of the hydrophilic layer film. Therefore, developing new detection methods and improving the sensitivity and accuracy of the detection methods are the main problems that need to be solved urgently.

SUMMARY OF THE INVENTION

In view of the above technical problems, the present invention provides a hematocrit calibration method and a biosensor testing device using the calibration method, which can eliminate the influence of blood hematocrit on the measurement of analyte concentration and improve the detection accuracy.

To achieve the above object, the technical scheme adopted in the present invention is:

A hematocrit correction method, comprising the following steps:

S1, detect blood sample parameters of the blood sample;

S2, measuring hematocrit: according to the correlation curve between the parameters of the blood sample and the hematocrit, detect the hematocrit (HCT%) in the blood sample;

S3, measure the _initial analyte concentration value C;

S4, analyte concentration correction: using the measured blood hematocrit (HCT%) and the measured initial analyte concentration value C _initial , calculate the final corrected analyte concentration value C _end of the analyte.

As a preferred way, using the measured response current (I) of the blood sample, and using the correlation curve between the hematocrit (HCT%) and the response current (I) of the blood sample, convert the current hematocrit (HCT%) in the blood. ), corrected for the measured analyte content.

Further, the method for determining the correlation curve between the blood sample response current (I) and the hematocrit includes the following steps:

S2.1, obtain the standard hematocrit of blood samples with different hematocrits;

S2.2, convert the standard hematocrit value blood samples into blood samples with different hemoglobin concentrations;

S2.3, obtain the response current (I) of blood samples with different heme concentrations;

S2.4, establish the correlation curve between the heme concentration and the response current (I) of the blood sample;

S2.5, convert the correlation curve between the heme concentration and the response current (I) of the blood sample into a correlation curve between the hematocrit and the response current (I) of the blood sample.

Preferably, the correlation equation between hematocrit (HCT%) and blood current (I) is HCT%=a*X(I)+b; wherein a ranges from 0 to +0.2, and b ranges from 0 to +0.2 .

More preferably, the correlation equation between hematocrit (HCT%) and blood current (I) is HCT%=c*In(I)+d; where c ranges from 0 to +1, and d ranges from 0 to + 1.

As a preferred way, using the measured red blood cell impedance phase angle (tanφ) in the blood sample, and using the correlation curve between the hematocrit (HCT%) and the red blood cell impedance phase angle, convert the current hematocrit (HCT%) in the blood. , to correct for the measured analyte content.

Further, the method for determining the correlation curve between the red blood cell impedance phase angle (tanφ) and the hematocrit (HCT%) includes the following steps:

S200, test the red blood cell impedance phase angle (tanφ) in blood samples with different hematocrits of the test standard;

S210, establishing a correlation curve between different hematocrit and erythrocyte impedance phase angle (tanφ).

Preferably, the correlation equation between hematocrit (HCT%) and red blood cell impedance phase angle (tanφ) is HCT%=e*tanφ^2+f*tanφ+g; where e ranges from -0.01 to 0, and f ranges is -0.01 to +0.01, and the g range is 0 to 0.1.

Preferably, the equation for calculating the _final corrected analyte concentration value C of the analyte is:

C _end = C _beginning (k3+k1*HCT%)/(1+k2*HCT%); where k1 ranges from -1 to +1, k2 ranges from -1 to +1, and k3 ranges from -2 to +2 .

More preferably, the equation for calculating the _final corrected analyte concentration value C of the analyte is:

_Cend =k5* _Cend /(1+k4*HCT%) where k4 ranges from -1 to +1 and k5 ranges from 0 to +2.

The invention also discloses a biosensor testing device with hematocrit correction. The correlation curve between hematocrit (HCT%) and blood sample parameters in the hematocrit correction method described above is programmed into the biosensor testing device.

The present invention has the following beneficial effects:

The invention provides a hematocrit correction method and an electrochemical biosensor testing device with hematocrit correction. The electrochemical biosensor determines the blood hematocrit through the current value corresponding to the heme concentration of the blood, or determines the blood hematocrit through the erythrocyte impedance phase angle tanφ of the blood. Then, it is corrected by the measured analyte concentration correction equation, and the final analyte corrected concentration value is calculated. The method is simple and easy to implement, has few interference factors, and is accurate in testing, can effectively eliminate the influence of blood hematocrit on the determination of analyte concentration, and improve the accuracy and sensitivity of results.

Description of drawings

FIG. 1 is a schematic structural diagram of a biosensor with hematocrit correction according to an embodiment of the present invention.

FIG. 2 is a schematic flowchart of a method for measuring hematocrit in a biosensor according to an embodiment of the present invention.

FIG. 3 is a diagram showing the relationship between hematocrit and hemoglobin conversion in a biosensor according to an embodiment of the present invention.

FIG. 4 is a linear correlation curve diagram of the blood hematocrit calculated in Example 1 of the present invention and the measured standard blood hematocrit.

5 is a comparison diagram of the results before and after the hematocrit correction of the analyte concentration in Example 2-1 of the present invention.

6 is a comparison diagram of the results before and after the hematocrit correction of the analyte concentration in Example 2-2 of the present invention.

7 is a comparison diagram of the results before and after the hematocrit correction of the analyte concentration in Example 2-3 of the present invention.

FIG. 8 is a schematic structural diagram of a biosensor with hematocrit correction according to another embodiment of the present invention.

9 is a graph showing the correlation between different hematocrits and the red blood cell impedance phase angle tanφ in Example 3 of the present invention;

10 is a linear correlation curve diagram of the calculated blood hematocrit and the measured standard blood hematocrit in Example 3 of the present invention;

11 is a comparison diagram of the results before and after the blood sugar concentration was corrected by hematocrit in Example 4 of the present invention.

1. Electrode output terminal; 2. Electrode output terminal; 3. Electrode output terminal; 4. Electrode output terminal; 5. Electrode output terminal; 6. Reaction electrode; 7. Reaction electrode; 8. Counter electrode; 9. Section A channel (the first reagent layer); 10, the second channel (the second reagent layer); 11, the insulating layer; 12, the hydrophilic layer; 13, the base layer; 14, the inlet of the liquid to be tested; 15, the air hole; line. 31, electrode output end; 32, electrode output end; 33, electrode output end; 34, electrode output end; 35, electrode output end; 36, conductive line; 37, reaction electrode; 38, first auxiliary electrode; 39, working electrode 310, the second auxiliary electrode; 311, the insulating layer; 312, the base layer; 313, the reagent layer; 314, the hydrophilic film layer, 315, the inlet of the liquid to be measured;

Detailed ways

In order for those skilled in the art to understand the solutions of the present invention, the technical solutions in the embodiments of the present invention are completely and clearly described with reference to the drawings in the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention. , not all examples. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

Curve equations for hematocrit (HCT%) versus blood sample parameters are programmed into the test instrument used with electrochemical biosensors. 1 is a schematic structural diagram of a dual-channel electrochemical biosensor with hematocrit correction according to this embodiment, which includes a base layer 13 , a conductive layer disposed on the base layer 13 , and an insulating layer 11 above the conductive layer. The upper end of the conductive layer includes electrode output ends 1 to 5 , the lower end of the conductive layer includes a first working electrode 6 and a second working electrode 7 , and a counter electrode 8 shared by the first working electrode 6 and the second working electrode 7 . Conductive lines 16 are connected between the first working electrode 6 , the second working electrode 7 , the counter electrode 8 and the electrode output ends 1 to 5 . The first working electrode 6 and the counter electrode 8 constitute a first electrode group, and the second working electrode 7 and the counter electrode 8 constitute a second electrode group. The insulating layer 11 covers the part above the pins of the detection electrode group, and two inverted Y-shaped reaction channels are set according to the electrode arrangement of the conductive layer, which are the first channel 9 (the first reagent layer) and the second channel 10 (the second channel). reagent layer). A hydrophilic layer 12 is provided in the reaction channel. The front end of the hydrophilic layer 12 is provided with a liquid inlet 14 to be tested; the hydrophilic layer 12 at the rear end of the reaction channel is provided with air holes 15 respectively. The method for measuring heme concentration using the electrochemical biosensor of this embodiment, the test conditions are as follows: the first reaction channel and the second reaction channel are respectively applied under constant potential conditions between 0.2 and 1 volt to carry out the reaction; the first reagent layer The buffer solution in 9 is used to maintain the pH value in the range of 6 to 8, and the buffer solution in the second reagent layer 10 is used to maintain the pH value in the range of 5 to 8. The first reagent layer 9 includes a hemolytic agent, a first electron mediator, and a first stabilizer; the second reagent layer 10 includes a surfactant, a second electron mediator, an enzyme, and a second stabilizer.

The first electron mediator includes one of potassium ferricyanide, ferrocene, dimethyl ferrocene, and ferrocene diformate. The second electron mediator includes one of potassium ferricyanide, ruthenium trichlorohexaammonium, tetrathiafulvalene, ferrocene, dimethylferrocene, and ferrocene diformate. The hemolytic agent in the first reagent layer includes one or a combination of saponin, dodecyl sulfate, cetyltrimethylammonium bromide, and triton. The surfactant in the second reagent layer includes one or a combination of saponin, dodecyl sulfate, cetyltrimethylammonium bromide, and triton.

FIG. 2 is a schematic flowchart of the method for measuring hematocrit in the electrochemical biosensor of the present embodiment.

The method includes:

S2.1, use the capillary method or the hemocytometer method to obtain the standard hematocrit value of blood samples with different hematocrits;

S2.2, convert the standard hematocrit value blood samples into blood samples with different hemoglobin concentrations;

S2.3, obtain the response current (I) of blood samples with different heme concentrations;

S2.4, establish the correlation curve between the heme concentration and the response current (I) of the blood sample;

S2.5, convert the correlation curve between the heme concentration and the response current (I) of the blood sample into a correlation curve between the hematocrit and the response current (I) of the blood sample.

The correlation equation for hematocrit (HCT%) and blood sample response current (I) may be HCT%=a*In(I)+b; where a ranges from about 0 to about +1 and b ranges from about 0 to About +1. A curve equation for hematocrit (HCT%) versus heme test current value (I) is programmed into the test instrument used with electrochemical biosensors.

S2.6, according to the determined correlation curve between the current and the hematocrit, determine the hematocrit value (HCT%) of the detected blood sample.

Using the measured blood hematocrit value (HCT%) and the measured analyte concentration value C _initial , the final analyte concentration value C _final is calculated.

The equation for calculating the _final analyte concentration value Cend might be: _Cend =k2* _Cend /(1+k1*HCT%), where k1 ranges from about -1 to about +1 and k2 ranges from about 0 to about + 2.

The implementation process of the present invention will be specifically described below by taking the blood glucose test in the blood sample as an example.

Example 1: Determination of the blood hematocrit measurement equation.

The test items are mainly glucose concentration in whole blood or venous blood, and the calibration method test items are mainly analytes in whole blood, such as glucose, total cholesterol, creatinine, blood ketones, urea nitrogen, etc. The first electrode group and the second electrode group use: gold electrodes, carbon electrodes, silver electrodes or any combination thereof.

The test conditions were that the reaction was carried out under constant potential conditions between 0.2 and 1 volts applied to the first electrode group and the second electrode group, respectively. The buffer solution in the first reagent layer is used to maintain the pH value in the range of 6 to 8, and the buffer solution in the second reagent layer is used to maintain the pH value in the range of 5 to 8. Measurement methods include capillary method and blood cell counter method.

The first reagent layer includes a hemolytic agent, an electron mediator, a stabilizer, and the like; the second reagent layer includes a surfactant, an electron mediator, an enzyme, a stabilizer, and the like. The electron mediator in the first reagent layer includes one of potassium ferricyanide, ferrocene, dimethyl ferrocene, ferrocene diformate, etc., and the electron mediator in the second reagent layer includes potassium ferricyanide, ruthenium , one of tetrathiafulvalene, ferrocene, dimethyl ferrocene, ferrocene diformate, etc. The hemolytic agent in the first reagent layer includes one or any combination of saponin, dodecyl sulfate, cetyltrimethylammonium bromide, triton, etc.; the surfactant in the second reagent layer includes soap One or any combination of them, such as oxalic acid, dodecyl sulfuric acid, cetyl trimethyl ammonium bromide, triton, etc.

A1. Prepare multiple blood samples with the same blood glucose concentration, wherein the blood glucose concentration is 300 mg/dL, and the hematocrit is adjusted to 10%, 20%, 30%, 40%, 50%, 60%, and 70%, respectively.

A2. Convert the standard hematocrit value blood samples into blood samples with different heme concentrations, as shown in Figure 3. And the blood glucose sensor was used to test the response current value of blood samples with different heme concentrations. As shown in Table 1:

HCT% Heme Concentration (g/L) Current (uA) 10% 33.3 1.04 20% 66.7 1.48 30% 100 2.00 40% 133.2 2.92 50% 167 3.66 60% 199 5.30 70% 233 7.01

Table 1

A3. Using the data in Table 1, take the current value as the X-axis and the blood hematocrit as the Y-axis, perform linear fitting to obtain the relationship equation between blood (HCT%) and current value (I), namely

HCT%=0.315ln(x)+0.0828 (F-1)

Substitute the measured current value (I) into the above F-1 equation to obtain the calculated hematocrit, and the correlation with the measured standard hematocrit is shown in FIG. 4 .

As shown in Figure 4, the slope of the correlation curve is 0.9564, the intercept is 0.0235, and the linear correlation coefficient R2 is 0.9978, indicating that the correlation is good.

The correlation equation (F-1) of hematocrit (HCT%) and current (I) in A3 was programmed into the instrument's internal calibration chip for use with electrochemical biosensors.

Example 2: Determination of the calibration function equation of blood glucose concentration in the final blood sample

B1-1: Prepare multiple blood samples, adjust the hematocrit to 10%, 20%, 30%, 40%, 50%, 60%, 70%, and the blood glucose concentration is 110mg/dL, using YSI 2300STAT PLUS glucose The lactate analyzer was calibrated, ie C _YSI = 110 mg/dL. The blood glucose concentration C _was measured with a blood glucose electrochemical sensor without hematocrit correction equation. As shown in table 2.

Table 2

B1-2: Prepare multiple blood samples, adjust the hematocrit to 10%, 20%, 30%, 40%, 50%, 60%, 70%, and the blood glucose concentration is 300mg/dL, using YSI 2300STAT PLUS glucose The lactate analyzer was calibrated, ie C _YSI = 300 mg/dL. Blood glucose concentration C _was measured with a blood glucose electrochemical sensor without hematocrit correction equation. as shown in Table 3.

HCT% C_Beginning(mg/dL) 10% 440 20% 402 30% 347 40% 294 50% 252 60% 196 70% 172

table 3

B1-3: Prepare multiple blood samples, adjust the hematocrit to 10%, 20%, 30%, 40%, 50%, 60%, 70%, and the blood glucose concentration is 500mg/dL, using YSI 2300STAT PLUS glucose The lactate analyzer was calibrated, ie C _YSI = 500 mg/dL. The blood glucose concentration C _was measured with a blood glucose electrochemical sensor without hematocrit correction equation. As shown in Table 4.

HCT% C_Beginning(mg/dL) 10% 699 20% 670 30% 570 40% 498 50% 423 60% 337 70% 261

Table 4

Using the initial data in Table 2, Table 3, and Table 4 for statistical analysis, the correction function to obtain the final analyte concentration is:

C _end =0.61*C _beginning /(1-0.97*HCT%) (F-2)

The blood glucose concentration correction equation (F-2) obtained in Example 2 was programmed and entered on the instrument internal chip for use with electrochemical biosensors.

Figure 5, Figure 6, Figure 7 are the comparison charts of three different blood glucose concentrations before and after hematocrit correction, as shown in Figure 5, Figure 6, Figure 7, before the hematocrit correction, the measured blood glucose concentration and the YSI measurement value deviation Larger, the blood glucose concentration after hematocrit correction is in good agreement with the YSI test results.

The electrochemical biosensor using the method for measuring and correcting the hematocrit of the present invention will not be affected by the hematocrit when testing the concentration of the blood analyte, and the test result is more accurate and reliable.

The following examples use the measured red blood cell impedance phase angle (tanφ) in the blood sample, and use the correlation curve between the hematocrit (HCT%) and the red blood cell impedance phase angle to convert the current hematocrit (HCT%) in the blood. The analyte content was corrected for.

As shown in FIG. 8 , a schematic structural diagram of an electrochemical biosensor for measuring blood impedance phase angle of the present embodiment includes a base layer 312 , a conductive layer on the base layer 312 , and an insulating layer 311 disposed above the conductive layer. . One end of the conductive layer includes five electrode output ends 31-35, and the other end of the conductive layer is sequentially provided with a first auxiliary electrode 39, a working electrode 38, a reaction electrode 37, a second auxiliary electrode 310, a reaction electrode 37, a first auxiliary electrode 39, Conductive lines 36 are connected between the working electrode 38, the second auxiliary electrode 310 and the electrode output ends 31-35, the reaction channel at the lower end of the base layer is provided with a hydrophilic thin film layer 314, and the lower end of the hydrophilic thin film layer 314 is provided with a to-be-measured layer The liquid inlet 315 ; the upper end of the hydrophilic thin film layer 314 is provided with an air hole 316 , and the reaction electrode 37 and the second auxiliary electrode 310 are provided with a reagent layer 313 .

The buffer solution in the reagent layer 313 maintains the pH value in the range of 6 to 8.

The reagent layer 313 includes surfactants, electron mediators, enzymes, and stabilizers. The electron mediator includes one of potassium ferricyanide, ruthenium, tetrathiafulvalene, and ferrocene. The surfactant includes one or a combination of saponin, dodecyl sulfate, cetyltrimethylammonium bromide, and triton. The reaction electrode and the auxiliary electrode are silver electrodes.

The electrochemical biosensor of this embodiment measures the blood impedance phase angle, and the measurement conditions are as follows: the reaction electrode 7 and the second auxiliary electrode 10 are reacted under the constant potential condition of 0.2-1.0V; The AC impedance amplitude of the AC voltage signal with the second auxiliary electrode 10 is 0.1-0.4V, and the frequency is 100-20000Hz.

The method for determining the correlation curve between the red blood cell impedance phase angle (tanφ) and the hematocrit (HCT%) includes the following steps:

S200, test the red blood cell impedance phase angle (tanφ) in standard blood samples with different hematocrits by capillary method or blood cell counter method ;

S210, establishing a correlation curve between different hematocrit and erythrocyte impedance phase angle (tanφ);

S220: Determine the hematocrit value (HCT%) of the detected blood sample according to the predetermined correlation curve between the impedance phase angle and the hematocrit.

The correlation equation between hematocrit (HCT%) and red blood cell impedance phase angle (tanφ) is HCT%=e*tanφ^2+f*tanφ+g; where e ranges from -0.01 to 0, and f ranges from -0.01 to +0.01, g range is 0 to 0.1.

Example 3: Determination of the blood hematocrit measurement equation.

The test items are mainly glucose concentration in whole blood or venous blood, and the calibration method test items are mainly analytes in whole blood, such as glucose, total cholesterol, creatinine, blood ketones, uric acid, etc. The first electrode group and the second electrode group use: gold electrodes, carbon electrodes, silver electrodes or any combination thereof.

The test condition is that the reaction is carried out under the constant potential condition of 0.2-1.0V applied to the second electrode group. The AC impedance amplitude of the AC voltage signal applied to the first electrode group is 0.1-0.4V, and the frequency is 100-20000Hz. The buffer solution in the second reagent layer is used to maintain the pH in the range of 6 to 8. Measurement methods include capillary method, blood cell counter method, and the like. The second reagent layer includes surfactants, electron mediators, enzymes, stabilizers, etc.; wherein, the electron mediators include one of potassium ferricyanide, ruthenium trichlorohexaammonium, tetrathiafulvalene, ferrocene, etc. ; Surfactant includes saponin, dodecyl sulfuric acid, cetyl trimethyl ammonium bromide, triton, etc., or any combination thereof.

A1. Prepare multiple blood samples with the same blood glucose concentration, wherein the blood glucose concentration is 110 mg/dL, and the hematocrit is adjusted to 10%, 20%, 30%, 40%, 50%, 60%, and 70%, respectively.

A2. Test the impedance phase angle value φ of blood samples with different hematocrit values (HCT%) with a blood glucose sensor. As shown in Table 5:

HCT% Impedance phase angle value φ(°) tanφ 10% 74.5 3.16 20% 72.6 3.19 30% 71.4 2.98 42% 68.7 2.56 50% 63.4 2.00 60% 56.7 1.52 70% 45.9 1.03

table 5

A3. Using the data in Table 5, take the red blood cell impedance phase angle tangent value tanφ as the X-axis and the blood hematocrit as the Y-axis, perform linear fitting, as shown in Figure 9, to obtain the blood (HCT%) and the impedance phase angle tanφ The relational equation of , namely:

HCT%=-0.0334*tanφ^2-0.0724*tanφ+0.8019 (F-3)

Substituting the measured impedance phase angle tanφ into the above F-3 equation, the calculated hematocrit is obtained, and the correlation with the measured standard hematocrit is shown in FIG. 10 .

As shown in Figure 10, the slope of the correlation curve is 0.9924, the intercept is 0.0028, and the linear correlation coefficient R2 is 0.9916, indicating that the correlation is good.

The correlation equation (F-1) of hematocrit (HCT%) and impedance phase angle tanφ in A3 was programmed into the instrument internal calibration chip for use with electrochemical biosensors.

Example 4: Determination of the calibration function equation of the blood glucose concentration in the final blood sample.

B1-1: Prepare multiple blood samples, adjust the hematocrit to 10%, 20%, 30%, 40%, 50%, 60%, 70%, and the blood glucose concentration is 110mg/dL, using YSI 2300STAT PLUS glucose The lactate analyzer was calibrated, ie C _YSI = 110 mg/dL. Blood glucose concentration C _was measured with a blood glucose electrochemical sensor without hematocrit correction equation. As shown in Table 6:

HCT% C_Beginning(mg/dL) 10% 159 20% 143 30% 133 40% 111 50% 95 60% 75 70% 60

Table 6

Using the initial data in Table 6 for statistical analysis, the correction function to obtain the final analyte concentration is:

C _end =0.59*C _beginning /(1-0.99*HCT%) (F-4)

The blood glucose concentration correction equation (F-4) obtained in Example 4 was programmed and entered on the instrument internal chip for use with electrochemical biosensors.

Figure 11 is a comparison chart of blood glucose concentration before and after hematocrit correction. As shown in Figure 11, before hematocrit correction, the measured blood glucose concentration has a large deviation from the measured value of YSI, and the blood glucose concentration after hematocrit correction is compared with the YSI test. The results were consistent.

The electrochemical blood glucose test strip using the hematocrit measurement and correction method of the present invention will not be affected by the hematocrit when testing blood glucose concentration, and the test results are more accurate and reliable.

The above descriptions are only the embodiments of the present invention, and are not intended to limit the scope of the patent of the present invention. Any equivalent structure or equivalent process changes made by using the contents of the description and drawings of the present invention, or directly or indirectly applied to other related technologies Fields are similarly included in the scope of patent protection of the present invention.

Claims (10)

1. A hematocrit correction method, comprising the steps of:

s1, detecting blood sample parameters of the blood sample;

s2, measuring hematocrit: detecting hematocrit (HCT%) in the blood sample based on a correlation curve of a blood sample parameter to hematocrit;

s3, measuring initial analyte concentration value C_{First stage}；

S4, analyte concentration correction: using the measured hematocrit of blood (HCT%) and the measured initial analyte concentration value C_{First stage}Calculating the final corrected analyte concentration value C_{Final (a Chinese character of 'gan')}。

2. The hematocrit correction method according to claim 1, wherein:

the measured response current (I) of the blood sample is used, and the current hematocrit (HCT%) in the blood is converted by using a correlation curve of the hematocrit (HCT%) and the response current (I) of the blood sample, so that the measured content of the analyte is corrected.

3. The hematocrit correction method according to claim 2, wherein the correlation curve determining method of the blood sample response current (I) with the hematocrit includes the steps of:

s2.1, obtaining standard hematocrit of different hematocrit blood samples;

s2.2, converting the blood sample with the standard hematocrit value into blood samples with different heme concentrations;

s2.3, obtaining response currents (I) of blood samples with different heme concentrations;

s2.4, establishing a correlation curve of the heme concentration and the response current (I) of the blood sample;

and S2.5, converting the correlation curve of the heme concentration and the response current (I) of the blood sample into the correlation curve of the hematocrit and the response current (I) of the blood sample.

4. The hematocrit correction method according to claim 2, wherein a correlation equation of hematocrit (HCT%) with blood current (I) is:

HCT% ═ a × x (i) + b; wherein a ranges from 0 to +0.2 and b ranges from 0 to + 0.2.

5. The hematocrit correction method according to claim 2, wherein a correlation equation of hematocrit (HCT%) with blood current (I) is:

HCT% ═ c × in (i) + d; wherein c ranges from 0 to +1 and d ranges from 0 to + 1.

6. The hematocrit correction method according to claim 1, wherein:

testing the impedance phase angle (tan phi) of the red blood cells in the standard blood samples with different hematocrit values, and establishing a correlation curve of the different hematocrit values and the impedance phase angle (tan phi) of the red blood cells; the measured analyte content is corrected by converting the current hematocrit (HCT%) in the blood using the measured red blood cell impedance phase angle (tan phi) in the blood sample and using the correlation curve of the hematocrit (HCT%) and the red blood cell impedance phase angle.

7. The hematocrit correction method according to claim 6,

the correlation equation for hematocrit (HCT%) and red blood cell impedance phase angle (tan φ) is:

HCT% ═ e + tan φ ^2+ f + tan φ + g; wherein e ranges from-0.01 to 0, f ranges from-0.01 to +0.01, and g ranges from 0 to 0.1.

8. The hematocrit correction method according to any one of claims 2 to 17,

calculating the analyte Final corrected analyte concentration value C_{Final (a Chinese character of 'gan')}The equation of (a) is:

C_{final (a Chinese character of 'gan')}＝C_{First stage}(k3+ k 1% HCT%)/(1 + k 2% HCT%); wherein k1 ranges from-1 to +1, k2 rangesThe circumference is-1 to +1 and k3 ranges from-2 to + 2.

9. The hematocrit correction method according to any one of claims 2 to 7,

calculating the analyte Final corrected analyte concentration value C_{Final (a Chinese character of 'gan')}The equation of (a) is:

C_{final (a Chinese character of 'gan')}＝k5*C_{First stage}V (1+ k4 HCT%) where k4 ranges from-1 to +1 and k5 ranges from 0 to + 2.

10. A biosensor test device for performing the method of claim 1, wherein: the biosensor test device is programmed with an input hematocrit (HCT%) versus blood sample parameter correlation curve.

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