Test card for prothrombin time of blood sample, blood detection device and blood detection system

Abstract

The utility model provides a blood sample prothrombin time test card, a blood detection device and a blood detection system, and relates to the technical field of in vitro diagnosis. The test card comprises an electrode layer printed with electrodes, wherein a prothrombin time detection loop, an impedance detection loop, a sample injection detection loop and a startup detection loop are arranged on the electrode layer. According to the test card, prothrombin time determination, hematocrit determination and hemoglobin content determination are combined in the same test card, so that the blood coagulation capability of a sample can be quickly and accurately evaluated.

Description

Technical Field

[0001] The utility model relates to the technical field of in vitro diagnosis, in particular to a test card, a device and a system for prothrombin time of a blood sample. Background Art

[0002] The following statements merely provide background information related to the present invention and do not necessarily constitute prior art.

[0003] Prothrombin time (PT) is an important indicator for evaluating exogenous coagulation function in clinical practice, and is widely used in preoperative coagulation function screening and evaluation of the therapeutic effect of anticoagulants. At present, the main method for measuring blood prothrombin time (PT) in hospitals is to use a large coagulation analyzer. This method uses optical principles to measure and has the characteristics of high accuracy and reliability, but the equipment has certain requirements for operators, and the measurement method has the disadvantages of complex operation and time-consuming. In recent years, POCT (point-of-care testing) technology has developed rapidly, and the market demand is to detect the target quickly and easily, and traditional detection methods have been difficult to meet the demand. Electrochemical biochemical sensor technology is particularly suitable for POCT because of its high sensitivity, short detection time and simple operation. However, current POCT detection products usually only target one target, and in actual applications, it is often necessary to detect multiple targets in blood samples. In addition, the prothrombin time test cards on the market have the following problems: 1) Lack of sample sufficiency detection function, resulting in incorrect test results that cannot be discovered in time when the sample volume is insufficient, resulting in misjudgment of the test results; 2) Lack of hematocrit detection function, unable to reduce the impact of hematocrit on the test results, thus affecting the accuracy of the test results. Especially for infants and the elderly with abnormal hematocrit. Therefore, POCT products that can detect multiple targets including prothrombin time are currently needed in the market.

[0004] In view of this, the present utility model is proposed. Utility Model Content

[0005] The utility model aims to provide a test card for prothrombin time of a blood sample, so as to quickly and accurately evaluate the blood coagulation ability of the sample.

[0006] In order to solve the above technical problems, the utility model adopts the following technical solutions:

[0007] In a first aspect, a test card for prothrombin time of a blood sample is provided, the test card comprising an electrode layer printed with electrodes, the electrodes comprising a working electrode for detecting a sample and a counter electrode for forming a circuit; the two ends of each electrode are respectively a first electrode end and a second electrode end;

[0008] The electrode layer is provided with a reaction area, the reaction area is filled with dry attached reaction reagents, and the reaction area covers the first electrode ends of all working electrodes; the working electrodes, reaction reagents and counter electrodes are connected to form a circuit;

[0009] The working electrodes include a PT detection working electrode, a sample injection detection electrode and an impedance working electrode;

[0010] The counter electrodes include PT detection counter electrodes and impedance counter electrodes;

[0011] The PT detection working electrode and the PT detection counter electrode are used to form a prothrombin time detection circuit;

[0012] The sample injection detection electrode and the PT detection working electrode are used to form a sample injection detection circuit;

[0013] The impedance working electrode and the impedance counter electrode are used to form an impedance detection loop;

[0014] The second electrode ends of the PT detection working electrode, the PT detection counter electrode and the injection detection electrode are used to connect to the current detection device; the second electrode ends of the impedance working electrode and the impedance counter electrode are used to connect to the resistance detection device.

[0015] In a second aspect, a blood testing device is provided, which includes the test card described in the first aspect and a detection device for detecting changes in circuit electrical signals in the test card; the circuit electrical signals include current signals and resistance signals.

[0016] In a third aspect, a blood testing system is provided, the blood testing system comprising the blood testing device of the second aspect and an analysis module; the analysis module records a first standard curve, the first standard curve is a standard curve of current and sample prothrombin time, and the analysis module converts the current value into the prothrombin time when executing the processing;

[0017] The analysis module also records the following (i) to (iii):

[0018] (i) a second standard curve, wherein the second standard curve is a standard curve of impedance and hematocrit; the analysis module converts the impedance value into hematocrit during execution;

[0019] (ii) the second standard curve and the third standard curve, wherein the third standard curve is a standard curve between hematocrit and hemoglobin content, and the analysis module converts the impedance value into hematocrit and then converts the hematocrit into hemoglobin content when executing the processing;

[0020] (iii) a fourth standard curve, wherein the fourth standard curve is a standard curve between impedance and hemoglobin content, and the analysis module converts the impedance value into the hemoglobin content when executing the processing.

[0021] Compared with the prior art, the utility model has the following beneficial effects:

[0022] The test card for detecting blood samples by electrochemical method provided by the utility model can combine the prothrombin time determination, hematocrit determination and hemoglobin content determination in the same test card, and has the following advantages: 1. The test card is also provided with a sampling detection circuit, which can quickly determine the inaccurate test results caused by insufficient sampling, avoid the wrong results caused by insufficient sampling, and then affect the result determination. At the same time, the hematocrit determination function is added to the test card, and the test results can be calibrated by measuring the hematocrit, reducing the influence of different hematocrits on the prothrombin time test, making the prothrombin test results more accurate. While measuring the hematocrit of the sample, the hemoglobin content of the sample is synchronously determined by using the proportional relationship between the hematocrit and the hemoglobin content, enriching the test function of the test card. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to more clearly illustrate the specific implementation methods of the utility model or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the utility model. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0024] Figure 1 A schematic diagram of a test card provided in an embodiment;

[0025] Figure 2 A schematic diagram of an electrode layer of a test card provided in an embodiment;

[0026] Figure 3 A schematic diagram of the double-sided adhesive layer of a test card provided in an embodiment;

[0027] Figure 4 A schematic diagram of a hydrophilic membrane layer of a test card provided in an embodiment;

[0028] Figure 5 The linear fitting results of prothrombin time of the test card in the embodiment and the commercially available test card for testing the same batch of samples;

[0029] Figure 6 1 is a correlation curve between the impedance of a blood sample detected by the test card of the embodiment and its hematocrit (HCT).

[0030] Icons: 1-electrode layer; 2-double-sided adhesive layer; 3-hydrophilic film layer; 4-electrode working area; 5-hollow area; 6-second sample loading hole; 7-air outlet hole; 8-first sample loading hole; 9-impedance working electrode; 10-PT detection working electrode; 11-injection detection electrode; 12-power-on electrode; 13-PT detection counter electrode; 14-impedance counter electrode. DETAILED DESCRIPTION

[0031] The technical solution of the utility model will be clearly and completely described below in conjunction with the embodiments. Obviously, the described embodiments are part of the embodiments of the utility model, not all of the embodiments. Based on the embodiments of the utility model, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the utility model.

[0032] In a first aspect, a test card for prothrombin time of a blood sample is provided, which is used to detect prothrombin time and hematocrit (HCT), and can further obtain hemoglobin content according to the hematocrit test result. The structure of the test card is as follows:

[0033] The test card comprises an electrode layer on which electrodes are printed, wherein the electrodes comprise a working electrode for detecting a sample and a counter electrode for forming a circuit.

[0034] The two ends of each electrode are respectively a first electrode end and a second electrode end; the first electrode end is used to contact the reaction reagent to connect the circuit; the second electrode end is used to connect the detection equipment, and the detection equipment is used to detect the changes in electrical signals of the circuit in the test card.

[0035] The electrode layer is provided with a reaction area, in which a dry and attached reaction reagent is filled. The reaction area covers the first electrode ends of all working electrodes, so that the working electrodes, the reaction reagents and the counter electrodes are connected to form a circuit.

[0036] The working electrode includes a PT detection working electrode, a sample injection detection electrode and an impedance working electrode. The counter electrode includes a PT detection counter electrode and an impedance counter electrode. The PT detection working electrode and the PT detection counter electrode are used to form a prothrombin time detection circuit. The sample injection detection electrode and the PT detection working electrode are used to form a sample injection detection circuit. The impedance working electrode and the impedance counter electrode are used to form an impedance detection circuit.

[0037] Among the above electrodes, the second electrode end of the PT detection working electrode, the second electrode end of the PT detection counter electrode and the second electrode end of the injection detection electrode are used to connect the current detection device. The test card tests the prothrombin time and the injection of the sample through the change of the current during the reaction.

[0038] In the above electrodes, the second electrode end of the impedance working electrode and the second electrode end of the impedance counter electrode are used to connect the resistance detection device. The test card tests the hematocrit through the impedance change during the reaction process, and further obtains the hemoglobin content according to the hematocrit test result.

[0039] In an optional embodiment, the electrode layer is further provided with a power-on electrode, which is directly connected to the PT detection electrode to form a loop, and the second electrode end of the power-on electrode is used to connect to a current detection device to detect the power-on state of the detection device through current changes.

[0040] The test card for prothrombin time of a blood sample is based on the electrochemical principle for detection. The detection principle is: the sample flows into the reaction area to restore the dry reaction reagent in the reaction area to liquid, so that the working electrode and the counter electrode are connected. Then the prothrombin time is detected by detecting the change of the current in the loop formed by the PT detection working electrode and the PT detection counter electrode; the change of the current in the loop formed by the injection detection electrode and the PT detection working electrode is detected to determine whether the injection amount is sufficient; the hematocrit and / or hemoglobin content are detected by the change of the impedance in the loop formed by the impedance working electrode and the impedance counter electrode. When the power-on electrode is also set, the power-on electrode and the PT detection counter electrode are connected, and the instrument is turned on. The test card combines the prothrombin time determination, hematocrit determination and hemoglobin content determination in the same test card, enriching the function of the test card. At the same time, since different hematocrits have an impact on the test results, the test results can be calibrated by measuring the hematocrit, so that the prothrombin test results are more accurate.

[0041] In an optional embodiment, in the direction away from the sample loading position, the first electrode end of each electrode in the reaction area is arranged in the following order: impedance working electrode, impedance counter electrode, PT detection working electrode, PT detection counter electrode and injection detection electrode, and the sample flows to the first electrode end in a vertical direction. The injection detection electrode is set at the position that contacts the sample last. If its circuit is connected during detection, it means that the sample volume is sufficient to contact the first electrode ends of all electrodes arranged at its front end, proving that the injection is sufficient. If no current passes, it means that the injection is insufficient. Adding an injection detection function can avoid the influence of inaccurate test results caused by insufficient injection. In an optional embodiment, the first electrode ends of each electrode are arranged in parallel, and the first electrode end of each electrode is perpendicular to the remaining part of the electrode.

[0042] In an optional embodiment, the electrodes are arranged in parallel with each other.

[0043] In an optional embodiment, the test card further comprises a hydrophilic film layer attached to the side of the electrode layer printed with electrodes, and the hydrophilic film layer is provided with a first sample loading hole. The blood sample dripped into the first sample loading hole flows to the reaction area under the guidance of the hydrophilic film.

[0044] In an optional embodiment, the test card is further wrapped with a double-sided adhesive layer, and the electrode layer and the hydrophilic film layer are bonded by the double-sided adhesive layer. The double-sided adhesive layer is provided with a second loading hole connected to the first loading hole, and the double-sided adhesive layer is provided with a hollow area for framing the reaction area, and the hollow area is connected to the second loading hole, so that the blood sample can only flow to the reaction area framed by the hollow area. It is understandable that the area framed by the hollow area can be larger than the reaction area, as long as the reaction reagent contained therein can be connected to the working electrode and the counter electrode after it is restored to liquid. It is understandable that the areas on the electrode layer that are not framed by the hollow area can also be attached by dry reaction reagents, but the blood sample cannot flow through these areas, so these dry reaction reagents cannot participate in the reaction.

[0045] In an optional embodiment, the hydrophilic membrane layer is further provided with an air outlet, and the hollow area extends to below the air outlet, so that the first sample addition hole, the second sample addition hole, the hollow area and the air outlet are connected.

[0046] In a second aspect, a blood testing device is provided, which includes the test card described in the first aspect and a detection device for detecting changes in electrical signals in the circuit of the test card, wherein the detection device can detect changes in current and resistance in the test card. The blood testing device may include multiple detection devices, each of which can independently detect current or resistance; the blood testing device may also be a detection device that has both current and resistance detection functions.

[0047] In a third aspect, a blood testing system is provided, the blood testing system comprising the blood testing device of the first aspect and an analysis module; the analysis module records a first standard curve, the first standard curve is a standard curve of current and sample prothrombin time, and the analysis module converts the current value into prothrombin time when executing the processing;

[0048] The analysis module also records the following (i) to (iii):

[0049] (i) a second standard curve, wherein the second standard curve is a standard curve of impedance and hematocrit; when the analysis module is executed, the impedance value is converted into the hematocrit.

[0050] (ii) the second standard curve and the third standard curve, wherein the second standard curve is the second standard curve in (i), and the third standard curve is a standard curve between hematocrit and hemoglobin content, and when the analysis module is executed, the impedance value is converted into hematocrit, and then the hematocrit is converted into hemoglobin content.

[0051] (iii) a fourth standard curve, wherein the fourth standard curve is a standard curve between impedance and hemoglobin content, and the analysis module converts the impedance value into the hemoglobin content when executing the processing.

[0052] In an optional embodiment, the blood testing system also includes a blood collection device.

[0053] The present invention is further described below by means of specific examples. However, it should be understood that these examples are only used for more detailed description and should not be understood as limiting the present invention in any form.

[0054] Example

[0055] This embodiment provides a blood sample test card, as shown in the schematic diagram Figure 1 , Figure 2 , Figure 3 and Figure 4 shown.

[0056] The test card of this embodiment is composed of three parts: an electrode layer 1 , a double-sided adhesive layer 2 and a hydrophilic film layer 3 .

[0057] Schematic diagram of electrode layer 1 Figure 2 As shown: the electrode working area 4 of the electrode layer 1 is printed with electrodes, and the reaction reagent is dried and attached to the electrode layer 1 and contacts one end of the electrode. The reaction reagents of this embodiment are as follows, and the reaction occurs in the reaction area of ​​the electrode layer 1, resulting in changes in current and impedance.

[0058] The reaction reagents include 90 wt% of buffer, 6 wt% of high molecular weight polymer, 2 wt% of electron transfer agent, 0.8 wt% of p-phenylenediamine-modified thrombin substrate, 0.5 wt% of tissue factor and 0.7 wt% of reductase;

[0059] The buffer is hepes buffer (0.1M, pH 7.4); the high molecular weight polymer is carboxymethyl cellulose (MW=90000); the electron transfer agent is potassium ferrocyanide; the tissue factor is recombinant lipidated human tissue factor; the reductase is alcohol dehydrogenase. The p-phenylenediamine-modified thrombin substrate is Tos-Gly-Pro-Arg-p-Phenylenediamine (Gly is glycine, Pro is proline, Arg is arginine, Tos is toluenesulfonamide, and Phenylenediamine is p-phenylenediamine), as shown in formula (I):

[0060]

[0061] The detection principle of the reaction reagent is as follows: the prothrombin time is calculated by detecting the current generated during the blood coagulation process based on the current value. Under the stimulation of tissue factor, the prothrombin in the blood is converted into thrombin. When the coagulation reaction occurs, the generated thrombin cuts the thrombin substrate, and the electron transfer agent p-phenylenediamine is cut off. At this time, an excitation voltage is applied to both ends of the electrode, and p-phenylenediamine is oxidized to quinone diimine to generate electron transfer, thereby generating current. As p-phenylenediamine is oxidized, the concentration on the electrode surface decreases. At this time, the oxidation product of p-phenylenediamine reacts with alcohol dehydrogenase, and quinone diimine can be reduced to p-phenylenediamine. The reduction reaction undergoes another electron transfer, so that the current generated by the reaction is amplified.

[0062] The electrodes include an impedance working electrode 9, a PT detection working electrode 10, an injection detection electrode 11, a power-on electrode 12, a PT detection counter electrode 13 and an impedance counter electrode 14, and the material of the electrodes is carbon slurry; the PT detection working electrode 10 and the PT detection counter electrode 13 constitute a prothrombin time detection circuit; the impedance working electrode 9 and the impedance counter electrode 14 constitute a detection circuit for detecting hematocrit; the injection detection electrode 11 and the PT detection working electrode 10 constitute a injection detection circuit; the power-on electrode 12 and the PT detection counter electrode 13 are connected.

[0063] The reaction reagent is dried and covered on the first electrode ends of the impedance working electrode 9, the PT detection working electrode 10, the injection detection electrode 11, the PT detection counter electrode 13 and the impedance counter electrode 14, and the reaction area is limited by the hollow area 5 of the double-sided adhesive layer 2. In the reaction area, the first electrode ends of each electrode are arranged in the following order in the direction away from the sample addition position: the impedance working electrode 9, the impedance counter electrode 14, the PT detection working electrode 10, the PT detection counter electrode 13 and the injection detection electrode 11, and the sample flows to the first electrode end in a vertical direction. The first electrode end is perpendicular to the rest of the electrode. The first electrode ends are arranged in parallel with each other, and the rest of the electrodes are also arranged in parallel with each other, such as Figure 2 shown.

[0064] When the sample flows through the first electrode end attached with dry reaction reagent, the sample restores the dry reaction reagent in the reaction area to liquid, and sequentially connects the impedance working electrode 9 and the impedance counter electrode 14 circuits, connects the PT detection working electrode 10 and the PT detection counter electrode 13 circuits, and connects the injection detection electrode 11 and the PT detection working electrode 10 circuits.

[0065] The schematic diagram of the double-sided adhesive layer 2 is as follows Figure 3 As shown, the schematic diagram of the hydrophilic membrane layer 3 is as follows Figure 4 As shown, the hydrophilic film layer 3 uses a 3M film. The side of the electrode layer 1 printed with electrodes and the hydrophilic film layer 3 are attached via a double-sided adhesive layer 2.

[0066] The double-sided adhesive layer 2 is used to frame the area and region of the reaction by setting a hollow area 5. The electrode layer 1 in the hollow area 5 is not covered by the double-sided adhesive layer 2, and the electrode layer in the area is dry and adhered to the reaction reagent.

[0067] The hydrophilic film layer 3 is provided with a first sample loading hole 8, the double-sided adhesive layer 2 is provided with a second sample loading hole 6 connected to the first sample loading hole 8, and the hollow area 5 is connected to the second sample loading hole 6. The first sample loading hole 8 and the second sample loading hole 6 connected thereto are used to drip the test sample, and then the hydrophilicity of the hydrophilic film layer 3 is used to guide the test sample into the reaction area so that the reaction occurs on the electrode. The hydrophilic film layer 3 is also provided with an air outlet 7 connected to the hollow area 5, and the air outlet 7 is located on the other side of the reaction area relative to the first sample loading hole 8.

[0068] When in use, the power-on electrode 12 and the PT detection counter electrode 13 are turned on, the instrument is turned on, the sample to be tested is dripped into the first sample addition hole 8, and the hydrophilicity of the hydrophilic membrane layer 3 is used to guide the test sample into the reaction area. The PT detection working electrode 10 and the PT detection counter electrode 13 constitute the current change of the prothrombin time detection circuit to detect the prothrombin time; the detection impedance working electrode 9 and the impedance counter electrode 14 constitute the impedance change of the detection circuit for detecting the hematocrit to detect the hematocrit, and the hemoglobin content is further obtained after conversion.

[0069] The preparation method of the test card of this embodiment includes substrate drying, electrode printing, reaction reagent attachment, double-sided tape lamination, hydrophilic film lamination and cutting in sequence. Electrode printing adopts screen printing process, and the printed substrate is passed through a tunnel furnace, baked at 90-110°C for 10-15min, and the printed substrate is collected as an electrode layer. The reaction reagent adopts a liquid dot process, and the reaction reagent is dotted in the area defined by the reaction area, and then placed in a tunnel furnace at 40-60°C for 10-15min, and then double-sided tape and hydrophilic film are affixed, and cutting can obtain a prothrombin time test card.

[0070] Effect example

[0071] 1. Actual sample testing:

[0072] The test method is as follows: After the test card in the above embodiment is inserted into the instrument and incubated at 37°C, fingertip blood is collected with a blood collection pen and then added to the test card injection port, or anticoagulant venous blood: according to venous blood: Ca 2+ =10:1 ratio, and then add the sample to the test card injection port. Oxidation current will be generated during the coagulation process, and a standard curve of oxidation current and sample prothrombin time is constructed. Then the sample oxidation current is brought into the standard curve to obtain the prothrombin time.

[0073] Some venous blood samples were selected from the hospital, and the prothrombin time of the samples was tested using the test card in Example 2 and a commercially available coagulation instrument. The results are as follows: Figure 5 As shown, the linear fit R 2 =0.963, indicating that the test card of the embodiment can be used for actual sample detection.

[0074] 2. Hematocrit and hemoglobin content determination

[0075] The test card prepared in the embodiment can also detect hematocrit, which indicates the proportion of red blood cells in the blood. Different hematocrits have different impedance values, and the hematocrit of the sample can be measured by measuring the impedance. Figure 6 As shown, the impedance of blood samples has a good correlation with their hematocrit, R 2 =0.984465, so the hematocrit can be calculated from the measured impedance data. Samples with different hematocrits have an impact on the test results. By measuring the hematocrit T and calibrating it, the test results can be made more accurate.

[0076] Hemoglobin is a chromoprotein mainly found in the red blood cells of vertebrates. Its main function is to carry oxygen and carbon dioxide in the human body. Hemoglobin exists in red blood cells, and different hematocrits contain different amounts of hemoglobin.

[0077] According to the literature, Haemoglobin and haematocrit: is the threefold conversion valid for assessing anaemia in malaria-endemic settings, there is a correlation between hematocrit and hemoglobin content, that is, Hb (g / dL) = HCT (%) / 3. In this way, the hemoglobin content of a blood sample can be obtained by measuring the hematocrit of the blood sample.

[0078] Therefore, the test card prepared in the embodiment can measure the hematocrit and hemoglobin content of the blood sample while measuring the prothrombin time, thereby enriching the detection function of the test card.

[0079] Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of the utility model, rather than to limit it. Although the utility model has been described in detail with reference to the aforementioned embodiments, ordinary technicians in this field should understand that they can still modify the technical solutions recorded in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not make the essence of the corresponding technical solution deviate from the scope of the technical solution of the embodiments of the utility model.

Claims

1. A test card for prothrombin time of a blood sample, characterized in that: It comprises an electrode layer printed with electrodes, wherein the electrodes comprise a working electrode for detecting a sample and a counter electrode for forming a circuit; the two ends of each electrode are respectively a first electrode end and a second electrode end; The electrode layer is provided with a reaction area, the reaction area is filled with dry attached reaction reagents, and the reaction area covers the first electrode ends of all working electrodes; the working electrodes, reaction reagents and counter electrodes are connected to form a circuit; The working electrodes include a PT detection working electrode, a sample injection detection electrode and an impedance working electrode; The counter electrodes include PT detection counter electrodes and impedance counter electrodes; The PT detection working electrode and the PT detection counter electrode are used to form a prothrombin time detection circuit; The sample injection detection electrode and the PT detection working electrode are used to form a sample injection detection circuit; The impedance working electrode and the impedance counter electrode are used to form an impedance detection loop; The second electrode ends of the PT detection working electrode, the PT detection counter electrode and the injection detection electrode are used to connect to the current detection device; the second electrode ends of the impedance working electrode and the impedance counter electrode are used to connect to the resistance detection device.

2. The test card according to claim 1, characterized in that: In the reaction area, the first electrode ends of the electrodes are arranged in sequence in the following order in a direction away from the sample loading position; Impedance working electrode, impedance counter electrode, PT detection working electrode, PT detection counter electrode and injection detection electrode, the sample flows to the first electrode end in a vertical direction.

3. The test card according to claim 1, characterized in that: The electrode layer is also provided with a power-on electrode, which is directly connected with the PT detection electrode to form a loop; the second electrode end of the power-on electrode is used to connect to a current detection device.

4. The test card according to claim 1, characterized in that: The first electrode ends of the electrodes are arranged in parallel, and the first electrode end of each electrode is perpendicular to the remaining portion of the electrode.

5. The test card according to any one of claims 1 to 4, characterized in that: The test card further comprises a hydrophilic film layer attached to a side of the electrode layer on which the electrodes are printed, and the hydrophilic film layer is provided with a first sample addition hole.

6. The test card according to claim 5, characterized in that: The test card is also covered with a double-sided adhesive layer, and the electrode layer and the hydrophilic film layer are bonded together by the double-sided adhesive layer; The double-sided adhesive layer is provided with a second sample loading hole connected to the first sample loading hole. The double-sided adhesive layer is provided to frame a hollow area of ​​the reaction area, and the hollow area is connected to the second sample loading hole.

7. The test card according to claim 6, characterized in that: The hydrophilic film layer is also provided with an air outlet hole, and the hollow area extends to below the air outlet hole.

8. A blood testing device, characterized in that: It comprises the test card according to any one of claims 1 to 7 and a detection device for detecting changes in circuit electrical signals in the test card; the circuit electrical signals include current signals and resistance signals.

9. A blood testing system, characterized in that: The device comprises the blood testing device and the analysis module as claimed in claim 8; the analysis module records a first standard curve, the first standard curve is a standard curve of current and prothrombin time of a sample, and the analysis module converts the current value into prothrombin time when executing the processing; The analysis module also records the following (i) to (iii): (i) a second standard curve, wherein the second standard curve is a standard curve of impedance and hematocrit; the analysis module converts the impedance value into hematocrit during execution; (ii) the second standard curve and the third standard curve, wherein the third standard curve is a standard curve between hematocrit and hemoglobin content, and the analysis module converts the impedance value into hematocrit and then converts the hematocrit into hemoglobin content when executing the processing; (iii) a fourth standard curve, wherein the fourth standard curve is a standard curve between impedance and hemoglobin content, and the analysis module converts the impedance value into the hemoglobin content when executing the processing.

10. The blood testing system according to claim 9, characterized in that: Also included are blood collection devices.

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