CN114935599B - Method for determining whether an amount of sample added is sufficient and method for detecting an analyte concentration in a sample - Google Patents
Method for determining whether an amount of sample added is sufficient and method for detecting an analyte concentration in a sample Download PDFInfo
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- CN114935599B CN114935599B CN202210368004.XA CN202210368004A CN114935599B CN 114935599 B CN114935599 B CN 114935599B CN 202210368004 A CN202210368004 A CN 202210368004A CN 114935599 B CN114935599 B CN 114935599B
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- 238000000034 method Methods 0.000 title claims abstract description 45
- 239000012491 analyte Substances 0.000 title claims abstract description 22
- 238000001514 detection method Methods 0.000 claims abstract description 49
- 238000000840 electrochemical analysis Methods 0.000 claims abstract description 29
- 238000006243 chemical reaction Methods 0.000 claims description 10
- 230000007547 defect Effects 0.000 abstract description 142
- 238000012360 testing method Methods 0.000 abstract description 34
- 239000008280 blood Substances 0.000 description 85
- 210000004369 blood Anatomy 0.000 description 85
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 49
- 239000008103 glucose Substances 0.000 description 49
- 239000000376 reactant Substances 0.000 description 6
- 239000000243 solution Substances 0.000 description 6
- 108090000790 Enzymes Proteins 0.000 description 4
- 102000004190 Enzymes Human genes 0.000 description 4
- 229940088598 enzyme Drugs 0.000 description 4
- 230000009471 action Effects 0.000 description 3
- 239000003153 chemical reaction reagent Substances 0.000 description 3
- 230000008569 process Effects 0.000 description 3
- BQCADISMDOOEFD-UHFFFAOYSA-N Silver Chemical compound [Ag] BQCADISMDOOEFD-UHFFFAOYSA-N 0.000 description 2
- 239000002390 adhesive tape Substances 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 125000002791 glucosyl group Chemical group C1([C@H](O)[C@@H](O)[C@H](O)[C@H](O1)CO)* 0.000 description 2
- 238000002847 impedance measurement Methods 0.000 description 2
- 229910052709 silver Inorganic materials 0.000 description 2
- 239000004332 silver Substances 0.000 description 2
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 1
- 108010015776 Glucose oxidase Proteins 0.000 description 1
- 239000004366 Glucose oxidase Substances 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 229910052799 carbon Inorganic materials 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- KTWOOEGAPBSYNW-UHFFFAOYSA-N ferrocene Chemical compound [Fe+2].C=1C=C[CH-]C=1.C=1C=C[CH-]C=1 KTWOOEGAPBSYNW-UHFFFAOYSA-N 0.000 description 1
- 229940116332 glucose oxidase Drugs 0.000 description 1
- 235000019420 glucose oxidase Nutrition 0.000 description 1
- 229920003063 hydroxymethyl cellulose Polymers 0.000 description 1
- 229940031574 hydroxymethyl cellulose Drugs 0.000 description 1
- -1 i.e. Substances 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- VNWKTOKETHGBQD-UHFFFAOYSA-N methane Chemical compound C VNWKTOKETHGBQD-UHFFFAOYSA-N 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 239000008055 phosphate buffer solution Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
- G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
- G01N27/416—Systems
Abstract
The invention relates to the technical field of electrochemical analysis, and provides a method for judging whether the added sample amount is sufficient or not and a method for detecting the concentration of an analyte in a sample. The method for judging whether the added sample amount is sufficient comprises the following steps: s1: connecting electrochemical test paper with an electronic detection system, and adding a sample; s2: applying alternating current between the working electrode and the counter electrode to obtain impedance Z 1 The method comprises the steps of carrying out a first treatment on the surface of the S3: applying alternating current between the fourth electrode and the third electrode to obtain impedance Z 2 The method comprises the steps of carrying out a first treatment on the surface of the S4: when the absolute value of the impedance deviation or the absolute value of the impedance deviation rate is larger than a preset value, judging that the added sample quantity does not meet the sample quantity required by detection; and when the absolute value of the impedance deviation or the absolute value of the impedance deviation rate is smaller than or equal to a preset value, judging that the added sample quantity meets the sample quantity required by detection. The invention overcomes the defects of the prior art, and solves the problem that the test result is inaccurate because timely judgment cannot be carried out when the situation of insufficient sample addition occurs.
Description
Technical Field
The invention relates to the technical field of electrochemical analysis, in particular to a method for judging whether the added sample amount is sufficient or not and a method for detecting the concentration of an analyte in a sample.
Background
The current blood feeding method of electrochemical test paper adopts a siphon method, and a sample is introduced into an internal reaction area by using an exhaust capillary channel. As the sample flows through the capillary into the capillary channel, the sample contacts the enzyme membrane and the electrode, and the analyte in the sample is then detected.
Current electrochemical test strips as shown in fig. 1, the electrochemical test strip includes an insulating base plate, an electrode system, and an insulating layer. The electrodes of the electrode system, the electrode leads, are printed on an insulating base plate. The three electrodes are all carbon electrodes, and are a third electrode 3, a working electrode 2 and a counter electrode 1 which are sequentially arranged. The electrode wire 4 is a silver electrode and is connected with each electrode. The insulating layer covers the electrode system, openings are formed above the electrodes at the front ends of the insulating layer, the reactant layer is positioned in the openings of the insulating layer and covers all the electrodes to form a reaction chamber 5, and the oval part in fig. 1 is the reactant layer. The end of the reaction chamber 5 penetrates the upper edge of the insulating layer and forms a sample inlet 5a, and the third electrode 3 for judging whether the detected sample amount is sufficient among the electrodes is closer to the sample inlet than the counter electrode 1.
The current method for judging insufficient sample addition by the electrochemical test paper comprises the following steps:
s1' applying a preset voltage between the working electrode and the counter electrode, and measuring the current value I between the working electrode and the counter electrode 1 ；
S2', applying a preset voltage between the third electrode and the working electrode, and measuring the current value I between the third electrode and the working electrode 2 ；
S3', when I 1 When the sample quantity is 0, judging that the added sample quantity does not meet the actual detection requirement; when I 1 When it is not 0, calculate I 1 And I 2 If the absolute value of the deviation or deviation rate is larger than the preset value, the added sample amount is judged to not meet the actual detection requirement, if the absolute value of the deviation or deviation rate is larger than the preset value, the added sample amount is judged to not meet the actual detection requirementWhen the absolute value is smaller than the preset value, I is calculated 1 Converted into the content of the detected substance in the detection sample.
Due to the different amounts of sample applied, the movement of the sample within the strip can occur in several situations: 1. if the amount of the added sample does not meet the requirement of the detection amount, the sample does not reach the counter electrode or only covers a part of the counter electrode within a preset detection time, in which case, the added sample does not reach the requirement of the working electrode for detection, so that the detection result of the analyte is inaccurate. 2. If a sufficient amount of sample is added, the sample will completely cover the counter electrode furthest from the sample inlet, where the sample must cover the area required for detection by the working electrode.
This technique has the following disadvantages:
1. the current electrochemical test paper technology adopts the comparison of the deviation of the current value or the absolute value of the deviation rate with the preset value to judge whether the added sample amount is sufficient. This is affected by the state of the enzyme film of the reagent layer, and when the enzyme film is uneven, the test current value is affected, and thus the insufficient sample addition is erroneously judged.
2. When the concentration of the sample is 0, the current is also 0, and the sample is judged to be insufficiently loaded even if the sample is sufficiently loaded.
To this end, we provide a method of determining whether the amount of sample added is sufficient, and on that basis we also provide a method for detecting the concentration of an analyte in a sample.
Disclosure of Invention
(one) solving the technical problems
Aiming at the defects of the prior art, the invention provides a method for judging whether the added sample amount is sufficient or not and a method for detecting the concentration of an analyte in a sample, and solves the problems that the test result is inaccurate because the current electrochemical test paper is adopted for testing and the timely judgment cannot be carried out when the situation of insufficient sample addition occurs.
(II) technical scheme
In order to achieve the above purpose, the invention is realized by the following technical scheme:
a method of determining whether an amount of a sample to be added is sufficient, the method comprising the steps of:
s1: connecting electrochemical test paper with an electronic detection system, and adding a sample;
the electrode system of the electrochemical test paper comprises a fourth electrode, a third electrode, a working electrode and a counter electrode which are sequentially arranged;
s2: applying alternating current between the working electrode and the counter electrode to obtain impedance Z 1 ；
S3: applying alternating current between the fourth electrode and the third electrode to obtain impedance Z 2 ；
S4: when the absolute value of the impedance deviation or the absolute value of the impedance deviation rate is larger than a preset value, judging that the added sample quantity does not meet the sample quantity required by detection; when the absolute value of the impedance deviation or the absolute value of the impedance deviation rate is smaller than or equal to a preset value, judging that the added sample quantity meets the sample quantity required by detection;
impedance deviation = Z 2- Z 1 Impedance deviation ratio= (Z 2 -Z 1 )/Z 2 。
Furthermore, the method is suitable for electrochemical analyte detection, and in step S4, the impedance deviation rate is adopted for judgment, and the preset value is 5%.
Further, in both step S2 and step S3, the ac impedance measurement is applied after a set time, and the set time is 1S.
A method for detecting the concentration of an analyte in a sample using an electrochemical test strip, characterized in that,
the detection method comprises the following steps:
s1: connecting electrochemical test paper with an electronic detection system, and adding a sample;
the electrode system of the electrochemical test paper comprises a fourth electrode, a third electrode, a working electrode and a counter electrode which are sequentially arranged;
s2: applying alternating current between the working electrode and the counter electrode to obtain impedance Z 1 ；
S3: applying alternating current between the fourth electrode and the third electrode to obtain impedance Z 2 ；
S4: when the absolute value of the impedance deviation or the absolute value of the impedance deviation rate is larger than a preset value, judging that the added sample quantity does not meet the sample quantity required by detection; when the absolute value of the impedance deviation or the absolute value of the impedance deviation rate is smaller than or equal to a preset value, judging that the added sample quantity meets the sample quantity required by detection;
impedance deviation = Z 2- Z 1 Impedance deviation ratio= (Z 2 -Z 1 )/Z 2 ；
S5: and after judging that the added sample quantity meets the sample quantity required by detection, applying direct current between the working electrode and the counter electrode, and obtaining an analyte concentration value C through conversion according to the measured current value.
Furthermore, the method is suitable for electrochemical analyte detection, and in step S4, the impedance deviation rate is adopted for judgment, and the preset value is 5%.
Further, in both step S2 and step S3, the ac impedance measurement is applied after a set time, and the set time is 1S.
(III) beneficial effects
After the detection by the method of the invention is carried out for a preset time, when the added sample quantity is insufficient, the detected sample can not reach the counter electrode or the sample only covers a very small part of the counter electrode, and the impedance Z can be changed due to the change of impedance caused by insufficient blood quantity 1 And impedance Z 2 The electronic detection system can feed back and display information of insufficient sample quantity to report errors; when the amount of sample added is sufficient, the sample covers a sufficient area of the counter electrode within a predetermined time, at which time the sample must cover a sufficient area of the working electrode because the area of all electrodes covered by the sample is sufficient, impedance Z 1 And impedance Z 2 The difference is small, and the sample is judged to be sufficient.
The method of the invention has the following beneficial effects:
(1) It can be judged whether the added sample amount is sufficient;
(2) Can not be influenced by the state of the enzyme film of the reaction reagent;
(3) It can be ensured that insufficient sample addition can be judged even when the concentration of the sample is 0.
Drawings
FIG. 1 is a schematic diagram of a conventional electrochemical test strip;
fig. 2 is a schematic structural diagram of the electrochemical test strip of the present invention.
Detailed Description
For the purpose of making the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention, and it is apparent that the described embodiments are some embodiments of the present invention, but not all embodiments of the present invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
Reagent, test paper description:
blood samples of different blood glucose concentrations: the sample venous blood is donated to staff; venous blood with blood glucose concentrations of 60mg/dL,120mg/dL,280mg/dL,420mg/dL and 580mg/dL respectively is prepared, and each blood glucose concentration is prepared by respectively preparing Hct into venous blood with concentration of 20%,30%,42%,55% and 65%.
Electrochemical test paper: as shown in fig. 2, the electrochemical test strip includes an insulating base plate, an electrode system, and an insulating layer. The electrodes of the electrode system, the electrode leads, are printed on an insulating base plate. The electrode is a carbon electrode and comprises a fourth electrode 6, a third electrode 3, a working electrode 2 and a counter electrode 1, and the electrode wire 4 is a silver electrode and is connected with each electrode. The insulating layer is composed of double faced adhesive tape and hydrophilic film, and the double faced adhesive tape sticks and covers the hydrophilic film on the electrode system. The front end of the insulating layer is provided with an opening above each electrode, the reactant layer is positioned in the opening of the insulating layer and covers all the electrodes to form a reaction chamber 5, and the oval part in the figure is the reactant layer. The end of the reaction chamber 5 penetrates through the upper edge of the insulating layer and forms a sample loading port.
Among the electrodes, the fourth electrode 6 is consistent with the working electrode 2, the third electrode 3 is consistent with the counter electrode 1, the distance between the fourth electrode 6 and the third electrode 3 is consistent with the distance between the working electrode 2 and the counter electrode 1, the distance between the counter electrode 1 and the sample inlet is farthest, and the distance between the fourth electrode 6 and the sample inlet is nearest.
Reactant layer (target analyte is glucose in blood): the solution was prepared by adding 2% glucose oxidase, 0.5% ferrocene (electron acceptor), 50% hydroxymethyl cellulose, 10% phosphate buffer solution (pH 8.0) and the balance water in mass percent. And 5 mu L of the prepared solution is dripped into a reaction chamber and dried to form a reactant layer, namely an area shown by an ellipse in FIG. 2.
Example 1
A method of determining whether an amount of a sample to be added is sufficient, the method comprising the steps of:
s1: connecting electrochemical test paper with an electronic detection system, and adding a sample;
the electrode system of the electrochemical test paper comprises a fourth electrode, a third electrode, a working electrode and a counter electrode which are sequentially arranged;
s2: after a set time, alternating current is applied between the working electrode and the counter electrode for a time t 1 To obtain the impedance Z 1 ；
S3: after a set time, alternating current is applied between the fourth electrode and the third electrode for a time t 2 To obtain the impedance Z 2 ；
S4: when the absolute value of the impedance deviation or the absolute value of the impedance deviation rate is larger than a preset value, judging that the added sample quantity does not meet the sample quantity required by detection; when the absolute value of the impedance deviation or the absolute value of the impedance deviation rate is smaller than or equal to a preset value, judging that the added sample quantity meets the sample quantity required by detection;
impedance deviation = Z 2- Z 1 Impedance deviation ratio= (Z 2 -Z 1 )/Z 2 。
When the method is applicable to blood glucose testing, step S2 and stepS3, t 1 、t 2 All are 1s; in the step S4, the impedance deviation rate is adopted for judgment, and the preset value is 5%.
Example 2
A method for detecting the concentration of an analyte in a sample using an electrochemical test strip, characterized in that,
the electrode system of the electrochemical test paper comprises a fourth electrode, a third electrode, a working electrode and a counter electrode which are distributed along the length direction of the test paper;
the detection method comprises the following steps:
s1: connecting electrochemical test paper with an electronic detection system, and adding a sample;
the electrode system of the electrochemical test paper comprises a fourth electrode, a third electrode, a working electrode and a counter electrode which are sequentially arranged;
s2: after a set time, alternating current is applied between the working electrode and the counter electrode for a time t 1 To obtain the impedance Z 1 ；
S3: after a set time, alternating current is applied between the fourth electrode and the third electrode for a time t 2 To obtain the impedance Z 2 ；
S4: when the absolute value of the impedance deviation or the absolute value of the impedance deviation rate is larger than a preset value, judging that the added sample quantity does not meet the sample quantity required by detection; when the absolute value of the impedance deviation or the absolute value of the impedance deviation rate is smaller than or equal to a preset value, judging that the added sample quantity meets the sample quantity required by detection;
impedance deviation = Z 2- Z 1 Impedance deviation ratio= (Z 2 -Z 1 )/Z 2 ；
S5: and after judging that the added sample quantity meets the sample quantity required by detection, applying direct current between the working electrode and the counter electrode, and obtaining an analyte concentration value C through conversion according to the measured current value.
When the method is suitable for blood glucose detection, t is calculated in step S2 and step S3 1 、t 2 All are 1s; in the step S4, the impedance deviation rate is adopted for judgment, and the preset value is 5%.
Analysis experiment of preset value
The target analyte is glucose in blood, i.e., blood glucose.
Blood glucose concentrations of 60mg/dL,120mg/dL,280mg/dL,420mg/dL,580mg/dL, respectively,
hct is 20%,30%,42%,55%,65% of blood is added into the test paper for detection. Wherein 10 groups of blood amounts satisfying the detection requirements and blood amounts not satisfying the detection requirements are added. The results are shown in tables 1 to 25.
TABLE 1 blood glucose concentration of 60mg/dL, hct of 20% blood sample was added to test paper and then whether the amount of the added sample was sufficient was judged
| Blood glucose concentration | Hct | Addition amount of | Z 1 | Z 2 | Deviation of | Deviation rate |
| 60 | 20％ | The defects are | 1032 | 3621 | 2589 | 71.50％ |
| 60 | 20％ | The defects are | 2165 | 3654 | 1489 | 40.70％ |
| 60 | 20％ | The defects are | 1565 | 3625 | 2060 | 56.80％ |
| 60 | 20％ | The defects are | 1021 | 1751 | 730 | 41.70％ |
| 60 | 20％ | The defects are | 2614 | 3684 | 1070 | 29.00％ |
| 60 | 20％ | The defects are | 1033 | 2561 | 1528 | 59.70％ |
| 60 | 20％ | The defects are | 1045 | 1862 | 817 | 43.90％ |
| 60 | 20％ | The defects are | 2561 | 3654 | 1093 | 29.90％ |
| 60 | 20％ | The defects are | 1089 | 1620 | 531 | 32.80％ |
| 60 | 20％ | The defects are | 2698 | 3641 | 943 | 25.90％ |
| 60 | 20％ | Sufficient enough to | 3562 | 3612 | 50 | 1.40％ |
| 60 | 20％ | Sufficient enough to | 3587 | 3651 | 64 | 1.80％ |
| 60 | 20％ | Sufficient enough to | 3578 | 3626 | 48 | 1.30％ |
| 60 | 20％ | Sufficient enough to | 3570 | 3642 | 72 | 2.00％ |
| 60 | 20％ | Sufficient enough to | 3582 | 3630 | 48 | 1.30％ |
| 60 | 20％ | Sufficient enough to | 3581 | 3654 | 73 | 2.00％ |
| 60 | 20％ | Sufficient enough to | 3593 | 3623 | 30 | 0.80％ |
| 60 | 20％ | Sufficient enough to | 3544 | 3612 | 68 | 1.90％ |
| 60 | 20％ | Sufficient enough to | 3566 | 3622 | 56 | 1.50％ |
| 60 | 20％ | Sufficient enough to | 3578 | 3645 | 67 | 1.84％ |
TABLE 2 blood glucose concentration of 120mg/dL, hct of 20% blood sample was added to test paper and then whether the amount of the added sample was sufficient was judged
TABLE 3 blood glucose concentration of 280mg/dL, hct of 20% blood sample was added to test paper and then whether the amount of the added sample was sufficient was judged
| Blood glucose concentration | Hct | Addition amount of | Z 1 | Z 2 | Deviation of | Deviation rate |
| 280 | 20％ | The defects are | 2563 | 3621 | 1058 | 29.22％ |
| 280 | 20％ | The defects are | 1033 | 3684 | 2651 | 71.96％ |
| 280 | 20％ | The defects are | 1039 | 2512 | 1473 | 58.64％ |
| 280 | 20％ | The defects are | 1015 | 1401 | 386 | 27.55％ |
| 280 | 20％ | The defects are | 1023 | 2321 | 1298 | 55.92％ |
| 280 | 20％ | The defects are | 1043 | 1356 | 313 | 23.08％ |
| 280 | 20％ | The defects are | 2511 | 3652 | 1141 | 31.24％ |
| 280 | 20％ | The defects are | 1022 | 1384 | 362 | 26.16％ |
| 280 | 20％ | The defects are | 2612 | 3653 | 1041 | 28.50％ |
| 280 | 20％ | The defects are | 1623 | 3677 | 2054 | 55.86％ |
| 280 | 20％ | Sufficient enough to | 3514 | 3638 | 124 | 3.41％ |
| 280 | 20％ | Sufficient enough to | 3564 | 3644 | 80 | 2.20％ |
| 280 | 20％ | Sufficient enough to | 3517 | 3638 | 121 | 3.33％ |
| 280 | 20％ | Sufficient enough to | 3546 | 3619 | 73 | 2.02％ |
| 280 | 20％ | Sufficient enough to | 3525 | 3656 | 131 | 3.58％ |
| 280 | 20％ | Sufficient enough to | 3578 | 3639 | 61 | 1.68％ |
| 280 | 20％ | Sufficient enough to | 3522 | 3627 | 105 | 2.89％ |
| 280 | 20％ | Sufficient enough to | 3546 | 3658 | 112 | 3.06％ |
| 280 | 20％ | Sufficient enough to | 3551 | 3648 | 97 | 2.66％ |
| 280 | 20％ | Sufficient enough to | 3567 | 3649 | 82 | 2.25％ |
TABLE 4 blood glucose concentration of 420mg/dL, hct of 20% blood sample and test paper were added to determine whether the sample was added
Adequate condition judgment
| Blood glucose concentration | Hct | Addition amount of | Z 1 | Z 2 | Deviation of | Deviation rate |
| 420 | 20％ | The defects are | 2145 | 3645 | 1500 | 41.15％ |
| 420 | 20％ | The defects are | 1025 | 3687 | 2662 | 72.20％ |
| 420 | 20％ | The defects are | 2174 | 3641 | 1467 | 40.29％ |
| 420 | 20％ | The defects are | 1063 | 2874 | 1811 | 63.01％ |
| 420 | 20％ | The defects are | 1046 | 2105 | 1059 | 50.31％ |
| 420 | 20％ | The defects are | 1024 | 1756 | 732 | 41.69％ |
| 420 | 20％ | The defects are | 2545 | 3681 | 1136 | 30.86％ |
| 420 | 20％ | The defects are | 2641 | 3615 | 974 | 26.94％ |
| 420 | 20％ | The defects are | 1037 | 3642 | 2605 | 71.53％ |
| 420 | 20％ | The defects are | 1085 | 2514 | 1429 | 56.84％ |
| 420 | 20％ | Sufficient enough to | 3519 | 3638 | 119 | 3.27％ |
| 420 | 20％ | Sufficient enough to | 3585 | 3644 | 59 | 1.62％ |
| 420 | 20％ | Sufficient enough to | 3504 | 3618 | 114 | 3.15％ |
| 420 | 20％ | Sufficient enough to | 3530 | 3621 | 91 | 2.51％ |
| 420 | 20％ | Sufficient enough to | 3538 | 3690 | 152 | 4.12％ |
| 420 | 20％ | Sufficient enough to | 3546 | 3693 | 147 | 3.98％ |
| 420 | 20％ | Sufficient enough to | 3555 | 3608 | 53 | 1.47％ |
| 420 | 20％ | Sufficient enough to | 3523 | 3624 | 101 | 2.79％ |
| 420 | 20％ | Sufficient enough to | 3543 | 3688 | 145 | 3.93％ |
| 420 | 20％ | Sufficient enough to | 3533 | 3611 | 78 | 2.16％ |
TABLE 5 blood glucose concentration of 580mg/dL, hct of 20% blood sample was added to test paper and then whether the amount of the added sample was sufficient was judged
TABLE 6 blood glucose concentration of 60mg/dL, hct of 30% blood sample was added to test paper and then whether the amount of the added sample was sufficient was judged
| Blood glucose concentration | Hct | Addition amount of | Z 1 | Z 2 | Deviation of | Deviation rate |
| 60 | 30％ | The defects are | 2544 | 3821 | 1277 | 71.50％ |
| 60 | 30％ | The defects are | 1035 | 2659 | 1624 | 40.70％ |
| 60 | 30％ | The defects are | 2744 | 3833 | 1089 | 56.80％ |
| 60 | 30％ | The defects are | 1044 | 1628 | 584 | 41.70％ |
| 60 | 30％ | The defects are | 1677 | 2699 | 1022 | 29.00％ |
| 60 | 30％ | The defects are | 2655 | 3864 | 1209 | 59.70％ |
| 60 | 30％ | The defects are | 1033 | 2088 | 1055 | 43.90％ |
| 60 | 30％ | The defects are | 2456 | 3814 | 1358 | 29.90％ |
| 60 | 30％ | The defects are | 1023 | 3827 | 2804 | 32.80％ |
| 60 | 30％ | The defects are | 2561 | 3835 | 1274 | 25.90％ |
| 60 | 30％ | Sufficient enough to | 3757 | 3859 | 102 | 2.64％ |
| 60 | 30％ | Sufficient enough to | 3707 | 3865 | 158 | 4.09％ |
| 60 | 30％ | Sufficient enough to | 3754 | 3842 | 88 | 2.29％ |
| 60 | 30％ | Sufficient enough to | 3703 | 3847 | 144 | 3.74％ |
| 60 | 30％ | Sufficient enough to | 3735 | 3848 | 113 | 2.94％ |
| 60 | 30％ | Sufficient enough to | 3703 | 3845 | 142 | 3.69％ |
| 60 | 30％ | Sufficient enough to | 3711 | 3871 | 160 | 4.13％ |
| 60 | 30％ | Sufficient enough to | 3719 | 3876 | 157 | 4.05％ |
| 60 | 30％ | Sufficient enough to | 3706 | 3825 | 119 | 3.11％ |
| 60 | 30％ | Sufficient enough to | 3724 | 3816 | 92 | 2.41％ |
TABLE 7 blood glucose concentration of 120mg/dL, hct of 30% blood sample was added to test paper and then whether the amount of the added sample was sufficient was judged
TABLE 8 blood glucose concentration of 280mg/dL, hct of 30% blood sample was added to test paper and then whether the amount of the added sample was sufficient was judged
| Blood glucose concentration | Hct | Addition amount of | Z 1 | Z 2 | Deviation of | Deviation rate |
| 280 | 30％ | The defects are | 2654 | 3812 | 1158 | 30.38％ |
| 280 | 30％ | The defects are | 1069 | 3853 | 2784 | 72.26％ |
| 280 | 30％ | The defects are | 1077 | 2563 | 1486 | 57.98％ |
| 280 | 30％ | The defects are | 1036 | 1584 | 548 | 34.60％ |
| 280 | 30％ | The defects are | 1965 | 3821 | 1856 | 48.57％ |
| 280 | 30％ | The defects are | 2587 | 3796 | 1209 | 31.85％ |
| 280 | 30％ | The defects are | 1069 | 2496 | 1427 | 57.17％ |
| 280 | 30％ | The defects are | 1037 | 1799 | 762 | 42.36％ |
| 280 | 30％ | The defects are | 2412 | 3857 | 1445 | 37.46％ |
| 280 | 30％ | The defects are | 2741 | 3847 | 1106 | 28.75％ |
| 280 | 30％ | Sufficient enough to | 3737 | 3808 | 71 | 1.86％ |
| 280 | 30％ | Sufficient enough to | 3726 | 3842 | 116 | 3.02％ |
| 280 | 30％ | Sufficient enough to | 3753 | 3842 | 89 | 2.32％ |
| 280 | 30％ | Sufficient enough to | 3741 | 3862 | 121 | 3.13％ |
| 280 | 30％ | Sufficient enough to | 3753 | 3818 | 65 | 1.70％ |
| 280 | 30％ | Sufficient enough to | 3732 | 3876 | 144 | 3.72％ |
| 280 | 30％ | Sufficient enough to | 3750 | 3839 | 89 | 2.32％ |
| 280 | 30％ | Sufficient enough to | 3705 | 3824 | 119 | 3.11％ |
| 280 | 30％ | Sufficient enough to | 3733 | 3854 | 121 | 3.14％ |
| 280 | 30％ | Sufficient enough to | 3729 | 3857 | 128 | 3.32％ |
TABLE 9 blood glucose concentration of 420mg/dL, hct of 30% blood sample was added to test paper and then whether the amount of the added sample was sufficient was judged
| Blood glucose concentration | Hct | Addition amount of | Z 1 | Z 2 | Deviation of | Deviation rate |
| 420 | 30％ | The defects are | 1036 | 3825 | 2789 | 72.92％ |
| 420 | 30％ | The defects are | 2568 | 3865 | 1297 | 33.56％ |
| 420 | 30％ | The defects are | 1063 | 2614 | 1551 | 59.33％ |
| 420 | 30％ | The defects are | 1101 | 1547 | 446 | 28.83％ |
| 420 | 30％ | The defects are | 2698 | 3835 | 1137 | 29.65％ |
| 420 | 30％ | The defects are | 2061 | 3799 | 1738 | 45.75％ |
| 420 | 30％ | The defects are | 1027 | 2432 | 1405 | 57.77％ |
| 420 | 30％ | The defects are | 1084 | 1821 | 737 | 40.47％ |
| 420 | 30％ | The defects are | 1063 | 3857 | 2794 | 72.44％ |
| 420 | 30％ | The defects are | 2614 | 3826 | 1212 | 31.68％ |
| 420 | 30％ | Sufficient enough to | 3727 | 3814 | 87 | 2.28％ |
| 420 | 30％ | Sufficient enough to | 3715 | 3816 | 101 | 2.65％ |
| 420 | 30％ | Sufficient enough to | 3728 | 3802 | 74 | 1.95％ |
| 420 | 30％ | Sufficient enough to | 3709 | 3827 | 118 | 3.08％ |
| 420 | 30％ | Sufficient enough to | 3747 | 3828 | 81 | 2.12％ |
| 420 | 30％ | Sufficient enough to | 3721 | 3828 | 107 | 2.80％ |
| 420 | 30％ | Sufficient enough to | 3705 | 3852 | 147 | 3.82％ |
| 420 | 30％ | Sufficient enough to | 3731 | 3866 | 135 | 3.49％ |
| 420 | 30％ | Sufficient enough to | 3758 | 3828 | 70 | 1.83％ |
| 420 | 30％ | Sufficient enough to | 3724 | 3856 | 132 | 3.42％ |
TABLE 10 blood glucose concentration of 580mg/dL, hct of 30% blood sample was added to test paper and then whether the amount of the added sample was sufficient was judged
/>
TABLE 11 blood glucose concentration of 60mg/dL, hct 42% blood sample was added to test paper and then whether the amount of the added sample was sufficient was judged
| Blood glucose concentration | Hct | Addition amount of | Z 1 | Z 2 | Deviation of | Deviation rate |
| 60 | 42％ | The defects are | 2003 | 4261 | 2258 | 52.99％ |
| 60 | 42％ | The defects are | 1231 | 4235 | 3004 | 70.93％ |
| 60 | 42％ | The defects are | 1053 | 2612 | 1559 | 59.69％ |
| 60 | 42％ | The defects are | 1032 | 1588 | 556 | 35.01％ |
| 60 | 42％ | The defects are | 3210 | 4294 | 1084 | 25.24％ |
| 60 | 42％ | The defects are | 1065 | 3001 | 1936 | 64.51％ |
| 60 | 42％ | The defects are | 1033 | 2413 | 1380 | 57.19％ |
| 60 | 42％ | The defects are | 2251 | 4284 | 2033 | 47.46％ |
| 60 | 42％ | The defects are | 1047 | 1825 | 778 | 42.63％ |
| 60 | 42％ | The defects are | 2103 | 4274 | 2171 | 50.80％ |
| 60 | 42％ | Sufficient enough to | 4120 | 4298 | 178 | 4.14％ |
| 60 | 42％ | Sufficient enough to | 4136 | 4229 | 93 | 2.20％ |
| 60 | 42％ | Sufficient enough to | 4126 | 4287 | 161 | 3.76％ |
| 60 | 42％ | Sufficient enough to | 4187 | 4202 | 15 | 0.36％ |
| 60 | 42％ | Sufficient enough to | 4178 | 4296 | 118 | 2.75％ |
| 60 | 42％ | Sufficient enough to | 4129 | 4283 | 154 | 3.60％ |
| 60 | 42％ | Sufficient enough to | 4132 | 4236 | 104 | 2.46％ |
| 60 | 42％ | Sufficient enough to | 4116 | 4252 | 136 | 3.20％ |
| 60 | 42％ | Sufficient enough to | 4109 | 4295 | 186 | 4.33％ |
| 60 | 42％ | Sufficient enough to | 4191 | 4213 | 22 | 0.52％ |
TABLE 12 blood glucose concentration 120mg/dL, hct 42% blood sample was added to test paper and then whether the amount of the added sample was sufficient was judged
/>
TABLE 13 blood glucose concentration of 280mg/dL, hct 42% blood sample was added to test paper and then whether the amount of the added sample was sufficient was judged
| Blood glucose concentration | Hct | Addition amount of | Z 1 | Z 2 | Deviation of | Deviation rate |
| 280 | 42％ | The defects are | 1033 | 2654 | 1621 | 61.08％ |
| 280 | 42％ | The defects are | 1062 | 1825 | 763 | 41.81％ |
| 280 | 42％ | The defects are | 3106 | 4263 | 1157 | 27.14％ |
| 280 | 42％ | The defects are | 1523 | 4251 | 2728 | 64.17％ |
| 280 | 42％ | The defects are | 1478 | 3002 | 1524 | 50.77％ |
| 280 | 42％ | The defects are | 3096 | 4287 | 1191 | 27.78％ |
| 280 | 42％ | The defects are | 1055 | 4231 | 3176 | 75.06％ |
| 280 | 42％ | The defects are | 1014 | 1742 | 728 | 41.79％ |
| 280 | 42％ | The defects are | 1048 | 2036 | 988 | 48.53％ |
| 280 | 42％ | The defects are | 2561 | 4263 | 1702 | 39.92％ |
| 280 | 42％ | Sufficient enough to | 4114 | 4266 | 152 | 3.56％ |
| 280 | 42％ | Sufficient enough to | 4126 | 4207 | 81 | 1.93％ |
| 280 | 42％ | Sufficient enough to | 4155 | 4220 | 65 | 1.54％ |
| 280 | 42％ | Sufficient enough to | 4146 | 4213 | 67 | 1.59％ |
| 280 | 42％ | Sufficient enough to | 4183 | 4279 | 96 | 2.24％ |
| 280 | 42％ | Sufficient enough to | 4120 | 4286 | 166 | 3.87％ |
| 280 | 42％ | Sufficient enough to | 4134 | 4282 | 148 | 3.46％ |
| 280 | 42％ | Sufficient enough to | 4139 | 4285 | 146 | 3.41％ |
| 280 | 42％ | Sufficient enough to | 4113 | 4250 | 137 | 3.22％ |
| 280 | 42％ | Sufficient enough to | 4173 | 4231 | 58 | 1.37％ |
TABLE 14 blood glucose concentration of 420mg/dL, hct 42% blood sample was added to test paper and then whether the amount of the added sample was sufficient was judged
/>
TABLE 15 blood glucose concentration of 580mg/dL, hct 42% blood sample was added to test paper and then whether the amount of the added sample was sufficient was judged
TABLE 16 blood glucose concentration of 60mg/dL, hct of 55% blood sample was added to test paper and then whether the amount of the added sample was sufficient was judged
| Blood glucose concentration | Hct | Addition amount of | Z 1 | Z 2 | Deviation of | Deviation rate |
| 60 | 55％ | The defects are | 1056 | 5269 | 4213 | 79.96％ |
| 60 | 55％ | The defects are | 1074 | 3562 | 2488 | 69.85％ |
| 60 | 55％ | The defects are | 3514 | 5236 | 1722 | 32.89％ |
| 60 | 55％ | The defects are | 2789 | 5287 | 2498 | 47.25％ |
| 60 | 55％ | The defects are | 1037 | 2651 | 1614 | 60.88％ |
| 60 | 55％ | The defects are | 3105 | 5245 | 2140 | 40.80％ |
| 60 | 55％ | The defects are | 2546 | 5284 | 2738 | 51.82％ |
| 60 | 55％ | The defects are | 1063 | 3017 | 1954 | 64.77％ |
| 60 | 55％ | The defects are | 1077 | 3639 | 2562 | 70.40％ |
| 60 | 55％ | The defects are | 3856 | 5234 | 1378 | 26.33％ |
| 60 | 55％ | Sufficient enough to | 5139 | 5221 | 82 | 1.57％ |
| 60 | 55％ | Sufficient enough to | 5162 | 5240 | 78 | 1.49％ |
| 60 | 55％ | Sufficient enough to | 5120 | 5205 | 85 | 1.63％ |
| 60 | 55％ | Sufficient enough to | 5176 | 5228 | 52 | 0.99％ |
| 60 | 55％ | Sufficient enough to | 5109 | 5282 | 173 | 3.28％ |
| 60 | 55％ | Sufficient enough to | 5185 | 5230 | 45 | 0.86％ |
| 60 | 55％ | Sufficient enough to | 5155 | 5238 | 83 | 1.58％ |
| 60 | 55％ | Sufficient enough to | 5149 | 5288 | 139 | 2.63％ |
| 60 | 55％ | Sufficient enough to | 5117 | 5287 | 170 | 3.22％ |
| 60 | 55％ | Sufficient enough to | 5149 | 5258 | 109 | 2.07％ |
TABLE 17 blood glucose concentration of 120mg/dL, hct of 55% blood sample was added to test paper and then whether the amount of the added sample was sufficient was judged
/>
TABLE 18 blood glucose concentration of 280mg/dL, hct of 55% blood sample was added to test paper and then whether the amount of the added sample was sufficient was judged
| Blood glucose concentration | Hct | Addition amount of | Z 1 | Z 2 | Deviation of | Deviation rate |
| 280 | 55％ | The defects are | 3514 | 5236 | 1722 | 32.89％ |
| 280 | 55％ | The defects are | 2147 | 5268 | 3121 | 59.24％ |
| 280 | 55％ | The defects are | 1087 | 3456 | 2369 | 68.55％ |
| 280 | 55％ | The defects are | 1077 | 2568 | 1491 | 58.06％ |
| 280 | 55％ | The defects are | 1034 | 5215 | 4181 | 80.17％ |
| 280 | 55％ | The defects are | 1043 | 2578 | 1535 | 59.54％ |
| 280 | 55％ | The defects are | 3594 | 5269 | 1675 | 31.79％ |
| 280 | 55％ | The defects are | 2618 | 5284 | 2666 | 50.45％ |
| 280 | 55％ | The defects are | 1125 | 5237 | 4112 | 78.52％ |
| 280 | 55％ | The defects are | 1062 | 3691 | 2629 | 71.23％ |
| 280 | 55％ | Sufficient enough to | 5193 | 5262 | 69 | 1.31％ |
| 280 | 55％ | Sufficient enough to | 5152 | 5201 | 49 | 0.94％ |
| 280 | 55％ | Sufficient enough to | 5155 | 5218 | 63 | 1.21％ |
| 280 | 55％ | Sufficient enough to | 5109 | 5260 | 151 | 2.87％ |
| 280 | 55％ | Sufficient enough to | 5116 | 5224 | 108 | 2.07％ |
| 280 | 55％ | Sufficient enough to | 5116 | 5292 | 176 | 3.33％ |
| 280 | 55％ | Sufficient enough to | 5181 | 5231 | 50 | 0.96％ |
| 280 | 55％ | Sufficient enough to | 5114 | 5220 | 106 | 2.03％ |
| 280 | 55％ | Sufficient enough to | 5167 | 5244 | 77 | 1.47％ |
| 280 | 55％ | Sufficient enough to | 5176 | 5266 | 90 | 1.71％ |
TABLE 19 blood glucose concentration of 420mg/dL, hct of 55% blood sample was added to test paper and then judged if the amount of the added sample was sufficient
/>
TABLE 20 blood glucose concentration of 580mg/dL, hct of 55% blood sample was added to test paper and then whether the amount of the added sample was sufficient was judged
| Blood glucose concentration | Hct | Addition amount of | Z 1 | Z 2 | Deviation of | Deviation rate |
| 580 | 55％ | The defects are | 3588 | 5236 | 1648 | 31.47％ |
| 580 | 55％ | The defects are | 1069 | 5214 | 4145 | 79.50％ |
| 580 | 55％ | The defects are | 1037 | 3654 | 2617 | 71.62％ |
| 580 | 55％ | The defects are | 1083 | 2589 | 1506 | 58.17％ |
| 580 | 55％ | The defects are | 4102 | 5233 | 1131 | 21.61％ |
| 580 | 55％ | The defects are | 2789 | 5298 | 2509 | 47.36％ |
| 580 | 55％ | The defects are | 1102 | 3541 | 2439 | 68.88％ |
| 580 | 55％ | The defects are | 1231 | 2654 | 1423 | 53.62％ |
| 580 | 55％ | The defects are | 2896 | 5274 | 2378 | 45.09％ |
| 580 | 55％ | The defects are | 3741 | 5288 | 1547 | 29.25％ |
| 580 | 55％ | Sufficient enough to | 5127 | 5202 | 75 | 1.44％ |
| 580 | 55％ | Sufficient enough to | 5134 | 5227 | 93 | 1.78％ |
| 580 | 55％ | Sufficient enough to | 5168 | 5225 | 57 | 1.09％ |
| 580 | 55％ | Sufficient enough to | 5115 | 5268 | 153 | 2.90％ |
| 580 | 55％ | Sufficient enough to | 5100 | 5259 | 159 | 3.02％ |
| 580 | 55％ | Sufficient enough to | 5164 | 5219 | 55 | 1.05％ |
| 580 | 55％ | Sufficient enough to | 5148 | 5224 | 76 | 1.45％ |
| 580 | 55％ | Sufficient enough to | 5123 | 5259 | 136 | 2.59％ |
| 580 | 55％ | Sufficient enough to | 5116 | 5233 | 117 | 2.24％ |
| 580 | 55％ | Sufficient enough to | 5108 | 5215 | 107 | 2.05％ |
TABLE 21 blood glucose concentration of 60mg/dL, hct of 65% blood sample was added to test paper and then whether the amount of the added sample was sufficient was judged
| Blood glucose concentration | Hct | Addition amount of | Z 1 | Z 2 | Deviation of | Deviation rate |
| 60 | 65％ | The defects are | 2156 | 5763 | 3607 | 62.59％ |
| 60 | 65％ | The defects are | 4236 | 5725 | 1489 | 26.01％ |
| 60 | 65％ | The defects are | 1065 | 3563 | 2498 | 70.11％ |
| 60 | 65％ | The defects are | 3728 | 5782 | 2054 | 35.52％ |
| 60 | 65％ | The defects are | 1084 | 2521 | 1437 | 57.00％ |
| 60 | 65％ | The defects are | 1067 | 5764 | 4697 | 81.49％ |
| 60 | 65％ | The defects are | 1055 | 3687 | 2632 | 71.39％ |
| 60 | 65％ | The defects are | 3645 | 5764 | 2119 | 36.76％ |
| 60 | 65％ | The defects are | 1063 | 3004 | 1941 | 64.61％ |
| 60 | 65％ | The defects are | 3695 | 5719 | 2024 | 35.39％ |
| 60 | 65％ | Sufficient enough to | 5693 | 5738 | 45 | 0.78％ |
| 60 | 65％ | Sufficient enough to | 5658 | 5775 | 117 | 2.03％ |
| 60 | 65％ | Sufficient enough to | 5661 | 5766 | 105 | 1.82％ |
| 60 | 65％ | Sufficient enough to | 5634 | 5707 | 73 | 1.28％ |
| 60 | 65％ | Sufficient enough to | 5618 | 5752 | 134 | 2.33％ |
| 60 | 65％ | Sufficient enough to | 5667 | 5763 | 96 | 1.67％ |
| 60 | 65％ | Sufficient enough to | 5637 | 5773 | 136 | 2.36％ |
| 60 | 65％ | Sufficient enough to | 5605 | 5740 | 135 | 2.35％ |
| 60 | 65％ | Sufficient enough to | 5698 | 5759 | 61 | 1.06％ |
| 60 | 65％ | Sufficient enough to | 5693 | 5709 | 16 | 0.28％ |
TABLE 22 blood glucose concentration 120mg/dL, hct 65% blood sample was added to test paper and then whether the amount of the added sample was sufficient was judged
/>
TABLE 23 blood glucose concentration of 280mg/dL, hct of 65% blood sample was added to test paper and then whether the amount of the added sample was sufficient was judged
| Blood glucose concentration | Hct | Addition amount of | Z 1 | Z 2 | Deviation of | Deviation rate |
| 280 | 65％ | The defects are | 3654 | 5741 | 2087 | 36.35％ |
| 280 | 65％ | The defects are | 1026 | 5733 | 4707 | 82.10％ |
| 280 | 65％ | The defects are | 1044 | 2589 | 1545 | 59.68％ |
| 280 | 65％ | The defects are | 1058 | 3612 | 2554 | 70.71％ |
| 280 | 65％ | The defects are | 3691 | 5784 | 2093 | 36.19％ |
| 280 | 65％ | The defects are | 2514 | 5732 | 3218 | 56.14％ |
| 280 | 65％ | The defects are | 1029 | 3698 | 2669 | 72.17％ |
| 280 | 65％ | The defects are | 1031 | 3214 | 2183 | 67.92％ |
| 280 | 65％ | The defects are | 3645 | 5723 | 2078 | 36.31％ |
| 280 | 65％ | The defects are | 1039 | 5795 | 4756 | 82.07％ |
| 280 | 65％ | Sufficient enough to | 5610 | 5764 | 154 | 2.67％ |
| 280 | 65％ | Sufficient enough to | 5667 | 5714 | 47 | 0.82％ |
| 280 | 65％ | Sufficient enough to | 5625 | 5779 | 154 | 2.66％ |
| 280 | 65％ | Sufficient enough to | 5651 | 5737 | 86 | 1.50％ |
| 280 | 65％ | Sufficient enough to | 5683 | 5767 | 84 | 1.46％ |
| 280 | 65％ | Sufficient enough to | 5675 | 5709 | 34 | 0.60％ |
| 280 | 65％ | Sufficient enough to | 5700 | 5707 | 7 | 0.12％ |
| 280 | 65％ | Sufficient enough to | 5602 | 5731 | 129 | 2.25％ |
| 280 | 65％ | Sufficient enough to | 5683 | 5765 | 82 | 1.42％ |
| 280 | 65％ | Sufficient enough to | 5683 | 5734 | 51 | 0.89％ |
TABLE 24 blood glucose concentration of 420mg/dL, hct 65% blood sample was added to test paper and then judged if the amount of the added sample was sufficient
/>
TABLE 25 blood glucose concentration of 580mg/dL, hct of 65% blood sample was added to test paper and then whether the amount of the added sample was sufficient was judged
| Blood glucose concentration | Hct | Addition amount of | Z 1 | Z 2 | Deviation of | Deviation rate |
| 580 | 65％ | The defects are | 3487 | 5736 | 2249 | 39.21％ |
| 580 | 65％ | The defects are | 2965 | 5784 | 2819 | 48.74％ |
| 580 | 65％ | The defects are | 1068 | 3965 | 2897 | 73.06％ |
| 580 | 65％ | The defects are | 1045 | 2856 | 1811 | 63.41％ |
| 580 | 65％ | The defects are | 3894 | 5719 | 1825 | 31.91％ |
| 580 | 65％ | The defects are | 1068 | 3748 | 2680 | 71.50％ |
| 580 | 65％ | The defects are | 2586 | 5729 | 3143 | 54.86％ |
| 580 | 65％ | The defects are | 1057 | 2965 | 1908 | 64.35％ |
| 580 | 65％ | The defects are | 3051 | 5789 | 2738 | 47.30％ |
| 580 | 65％ | The defects are | 3874 | 5728 | 1854 | 32.37％ |
| 580 | 65％ | Sufficient enough to | 5639 | 5718 | 79 | 1.38％ |
| 580 | 65％ | Sufficient enough to | 5630 | 5742 | 112 | 1.95％ |
| 580 | 65％ | Sufficient enough to | 5618 | 5717 | 99 | 1.73％ |
| 580 | 65％ | Sufficient enough to | 5681 | 5720 | 39 | 0.68％ |
| 580 | 65％ | Sufficient enough to | 5621 | 5746 | 125 | 2.18％ |
| 580 | 65％ | Sufficient enough to | 5679 | 5779 | 100 | 1.73％ |
| 580 | 65％ | Sufficient enough to | 5620 | 5775 | 155 | 2.68％ |
| 580 | 65％ | Sufficient enough to | 5627 | 5709 | 82 | 1.44％ |
| 580 | 65％ | Sufficient enough to | 5607 | 5716 | 109 | 1.91％ |
| 580 | 65％ | Sufficient enough to | 5617 | 5716 | 99 | 1.73％ |
Note that:
1. the deviation in the above table is the absolute value of the impedance deviation, and the deviation rate is the absolute value of the impedance deviation rate;
2. blood glucose concentration unit is mg/dL, Z 1 、Z 2 The unit is omega;
3. sufficient, i.e. the blood volume which meets the detection requirement, the addition amounts are all 5 mu L; the "shortage", i.e. the amount of blood which does not meet the detection requirements, is random and is less than 5. Mu.L.
The results show that Z when the sample amount is sufficient 1 And Z 2 The deviation between the two is very small, the deviation rate is between 0 and 4 percent, soThe preset deviation rate is 5%. But Z when the sample size does not meet the detection requirement 1 And Z 2 The deviation between the two is large, and the absolute value of the deviation rate is more than 20%. Experimental results show that Z is generated by test paper 1 And Z 2 And compare Z 1 And Z 2 The deviation rate of the sample can well reflect whether the sample adding amount is sufficient.
It should be noted that relational terms such as third and fourth, and the like are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Moreover, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one … …" does not exclude the presence of other like elements in a process, method, article, or apparatus that comprises the element.
The above embodiments are only for illustrating the technical solution of the present invention, and are not limiting; although the invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit and scope of the technical solutions of the embodiments of the present invention.
Claims (6)
1. A method of determining whether an amount of a sample to be added is sufficient, the method comprising the steps of:
s1: connecting electrochemical test paper with an electronic detection system, and adding a sample;
the electrode system of the electrochemical test paper comprises a fourth electrode, a third electrode, a working electrode and a counter electrode which are sequentially arranged;
s2: applying alternating current between the working electrode and the counter electrode to obtain impedance Z 1 ；
S3: applying alternating current between the fourth electrode and the third electrode to obtain impedance Z 2 ；
S4: when the absolute value of the impedance deviation or the absolute value of the impedance deviation rate is larger than a preset value, judging that the added sample quantity does not meet the sample quantity required by detection; when the absolute value of the impedance deviation or the absolute value of the impedance deviation rate is smaller than or equal to a preset value, judging that the added sample quantity meets the sample quantity required by detection;
impedance deviation = Z 2 -Z 1 Impedance deviation ratio= (Z 2 -Z 1 )/Z 2 。
2. A method of determining whether the amount of sample added is sufficient for electrochemical analyte detection as claimed in claim 1, wherein the impedance deviation is used in step S4 to determine that the predetermined value is 5%.
3. The method of claim 2, wherein in step S2 and step S3, the impedance is measured by applying ac power for a predetermined period of time, and the predetermined period of time is 1S.
4. A method for detecting the concentration of an analyte in a sample using an electrochemical test strip, characterized in that,
the detection method comprises the following steps:
s1: connecting electrochemical test paper with an electronic detection system, and adding a sample;
the electrode system of the electrochemical test paper comprises a fourth electrode, a third electrode, a working electrode and a counter electrode which are sequentially arranged;
s2: applying alternating current between the working electrode and the counter electrode to obtain impedance Z 1 ；
S3: applying alternating current between the fourth electrode and the third electrode to obtain impedance Z 2 ；
S4: when the absolute value of the impedance deviation or the absolute value of the impedance deviation rate is larger than a preset value, judging that the added sample quantity does not meet the sample quantity required by detection; when the absolute value of the impedance deviation or the absolute value of the impedance deviation rate is smaller than or equal to a preset value, judging that the added sample quantity meets the sample quantity required by detection;
impedance deviation = Z 2 -Z 1 Impedance deviation ratio= (Z 2 -Z 1 )/Z 2 ；
S5: and after judging that the added sample quantity meets the sample quantity required by detection, applying direct current between the working electrode and the counter electrode, and obtaining an analyte concentration value C through conversion according to the measured current value.
5. A method for detecting an analyte concentration in a sample according to claim 4, wherein the method is adapted for electrochemical analyte detection, and wherein the impedance deviation rate is used to determine in step S4, the predetermined value being 5%.
6. A method for detecting an analyte concentration in a sample according to claim 5, wherein in both step S2 and step S3, the alternating current electrical impedance is applied after a set time of 1S.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101900701A (en) * | 2009-05-25 | 2010-12-01 | 利多(香港)有限公司 | Biosensor |
| CN103487476A (en) * | 2009-05-25 | 2014-01-01 | 利多(香港)有限公司 | Biosensor |
| CN102147390A (en) * | 2009-12-18 | 2011-08-10 | 五鼎生物技术股份有限公司 | Electrochemical test strip, electrochemical test system, and measurement method using the same |
| CN107121478A (en) * | 2017-05-01 | 2017-09-01 | 台州亿联健医疗科技有限公司 | A kind of biology sensor that can detect that sample is not enough, method |
| CN111812180A (en) * | 2020-07-07 | 2020-10-23 | 江苏鱼跃医疗设备股份有限公司 | Method for identifying type of sample or fault type and biosensor device |
| CN111982987A (en) * | 2020-08-27 | 2020-11-24 | 江苏鱼跃医疗设备股份有限公司 | Glucose sensor and measurement correction method |
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