Detection device capable of correcting hematocrit

Abstract

The utility model relates to a detection device capable of correcting hematocrit. The detection device comprises a dry chemical test paper clamping shell upper cover, hematocrit detection test paper, dry chemical test paper and a dry chemical test paper clamping shell lower cover, the hematocrit detection test paper comprises a double faced adhesive tape, a hydrophilic film, a double faced adhesive tape, a hematocrit detection electrode and a double faced adhesive tape from top to bottom; the dry chemical test paper clamping shell upper cover comprises a sample adding hole; and the lower cover of the dry chemical test paper clamping shell comprises a detection hole.

Description

Technical Field

[0001] This utility model relates to the field of detection technology, and in particular to a detection device capable of performing hematocrit correction. Background Technology

[0002] Dry chemistry test strips typically detect hematocrit in blood samples within the range of 30-55%. However, many clinical samples have hematocrits below 30% or above 55%. Dry chemistry test strips will produce inaccurate results when testing these samples, but the instrument cannot detect this. Furthermore, when testing quality control samples, the test mode must be manually selected as quality control sample testing before sample addition, making automatic identification of quality control samples impossible.

[0003] When the hematocrit is too low, the reactants react with the enzyme membrane more quickly, resulting in a higher measurement current and thus a higher test result. In blood samples with very low hematocrit limits, the measurement result can be more than 200% higher. Conversely, when the hematocrit is too high, the reactants react with the enzyme membrane more slowly, resulting in a lower measurement current and thus a lower test result. The deviation can be as large as 50% or more.

[0004] Therefore, how to simultaneously detect dry chemical test strips and hematocrit, and how to correct the dry chemical test strip results using the hematocrit results, has become an urgent problem to be solved. Utility Model Content

[0005] To solve the above-mentioned technical problems, this utility model provides a detection device capable of correcting hematocrit. In this utility model, an impedance method test strip for detecting hematocrit is attached to the top cover of the dry chemical test strip casing, thereby achieving simultaneous detection of the dry chemical test strip and hematocrit, and correcting the detection results of the dry chemical test strip using the hematocrit detection results.

[0006] To achieve this objective, the present invention adopts the following technical solution:

[0007] In a first aspect, this utility model provides a detection device capable of performing hematocrit correction, the detection device comprising a dry chemical test paper cover, a hematocrit test paper, a dry chemical test paper, and a dry chemical test paper cover.

[0008] The hematocrit test strip comprises, from top to bottom, double-sided adhesive, a hydrophilic membrane, double-sided adhesive, a hematocrit detection electrode, and double-sided adhesive;

[0009] The dry chemical test strip cartridge cover includes a sample application hole, a hematocrit test strip interface end, and a bottom end;

[0010] The interface end of the hematocrit test strip is 2-8mm higher than the bottom end, for example, it can be 2mm, 3mm, 4mm, 5mm, 6mm, 7mm or 8mm, etc.

[0011] The bottom cover of the dry chemical test paper cartridge includes a detection hole.

[0012] In this invention, an impedance method test strip for detecting hematocrit is attached to the top cover of the dry chemical test strip casing and bonded to the dry chemical test strip. This allows for both dry chemical test strip detection and hematocrit detection, and the results of the dry chemical test strip test are corrected based on the hematocrit detection results. This enables the dry chemical test strip to detect different blood samples within the hematocrit range (0-70%) and improves the accuracy of test results for different HCT blood samples.

[0013] Without calibration, when a low HCT blood sample is added to the sample well, the plasma in the blood will quickly permeate to the reaction membrane and react, resulting in a higher signal value and a higher test result compared to the target value. When a high HCT blood sample with the same analyte concentration is added to the sample well, the plasma in the blood permeates to the reaction membrane and reacts more slowly, resulting in a lower signal value and a lower test result compared to the target value.

[0014] The double-sided adhesive tape has a groove 1, which is 0-5mm wide and 0-5mm long. The 0-5mm can be, for example, 0mm, 1mm, 2mm, 3mm, 4mm, or 5mm.

[0015] The hydrophilic membrane has a groove 2 at a position corresponding to the groove 1 of the double-sided adhesive. The groove 2 has a width of 0-5mm and a length of 0-2mm. The 0-5mm can be, for example, 0mm, 1mm, 2mm, 3mm, 4mm, or 5mm. The 0-2mm can be, for example, 0mm, 0.5mm, 1mm, 1.5mm, or 2mm.

[0016] After the hydrophilic membrane is bonded to the double-sided adhesive, grooves 1 and 2 combine to form an air vent.

[0017] Groove 1 and Groove 2 partially overlap, and the hydrophilic membrane has a thickness, so a Z-shaped channel is formed between the double-sided tape, the hydrophilic membrane, and the double-sided tape. When a blood sample enters, the blood will enter Groove 1 from the bottom of the Z-shape and stop flowing after reaching the air vent.

[0018] The hematocrit test strip has a hollow structure.

[0019] The dry chemical test strip cover forms a gap after it is attached to the hematocrit test strip.

[0020] In this invention, the hematocrit test strip can form a closed cavity between the top cover of the dry chemical test strip and the dry chemical test strip, which can ensure the uniform flow of blood sample during dry chemical testing and prevent blood sample leakage.

[0021] The sample application port is located above the void.

[0022] In this invention, the blood sample is added to the detection device through the sample inlet. Since the sample inlet is above the gap, it ensures that the sample flows smoothly into the dry chemical test strip and the hematocrit test strip.

[0023] The hematocrit detection electrode includes an electrode end and a detection end.

[0024] In this invention, after the electrode is inserted into the instrument and connected to the power supply, the power supply device is connected, and the detection of hematocrit is achieved by applying current to the detection end.

[0025] The location corresponding to the vent is the detection end;

[0026] A hollow blood groove is formed between the detection end and the hydrophilic membrane.

[0027] The upper and lower covers are connected by corresponding support columns. The shell part of the upper cover is lower than the height of the support columns. Therefore, when the hematocrit test strip is inserted, the electrode part connecting the instrument can extend out from the height difference between the support columns and the shell.

[0028] In this invention, grooves are designed in both the double-sided adhesive and the hydrophilic membrane. The air vent formed after the two are attached ensures that the blood sample flows into the motor unit of the hematocrit test strip for hematocrit detection.

[0029] In this invention, the hydrophilic membrane has a hydrophilic layer. When blood comes into contact with the hydrophilic membrane, the blood will automatically flow into the blood groove along the hydrophilic layer.

[0030] The number of detection holes is 1 to 5. For example, the number of 1 to 5 holes can be 1, 2, 3, 4 or 5.

[0031] In this invention, a detection hole is provided in the lower cover of the dry chemical test strip casing, and a detection device is connected to the detection hole to realize the detection of the dry chemical test strip. The number of detection holes is determined according to the actual dry chemical test strip detection.

[0032] The dry chemical test paper card cover has a groove 3 in the lower cover.

[0033] The dry chemical test paper is fixed in the groove 3.

[0034] In this invention, the dry chemical test strip is fixed in the groove of the lower cover of the dry chemical test strip holder to ensure the stability of the test strip. After use, the dry chemical test strip can be replaced with other dry chemical test strips and placed in the groove for retesting.

[0035] The bottom cover (4) of the dry chemical test paper cartridge is equipped with a handle.

[0036] Compared with the prior art, the present invention has at least the following beneficial effects:

[0037] 1. It can detect hematocrit of blood samples simultaneously with dry chemical test strips, and use the hematocrit test value to correct the test results of dry chemical test strips, thereby improving the test accuracy of different HCT blood samples.

[0038] 2. It can form a completely sealed cavity between the dry chemical test paper and the top cover, ensuring uniform flow of the test blood sample and preventing spillage of the test blood sample. Attached Figure Description

[0039] Figure 1 This is a structural diagram of a detection device capable of performing hematocrit correction.

[0040] Figure 2 This is a front cross-sectional view of a detection device capable of performing hematocrit correction.

[0041] Figure 3 This is a side cross-sectional view of a detection device capable of performing hematocrit correction.

[0042] Figure 4 This is a diagram showing the structural composition of hematocrit test strips.

[0043] Figure 5 This is a diagram of the composition of a hematocrit test strip.

[0044] Figure 6 This is a structural diagram of the hydrophilic membrane and double-sided adhesive.

[0045] Among them, 1-dry chemical test strip cover, 2-hematocrit test strip, 3-dry chemical test strip, 4-dry chemical test strip cover, 5-double-sided adhesive, 6-hydrophilic membrane, 7-double-sided adhesive, 8-hematocrit detection electrode, 9-double-sided adhesive, 10-sample application hole, 11-detection hole, 12-gap, 13-groove 1, 14-groove 2, 15-electric electrode, 16-detection end, 17-groove 3, 18-handle, 19-vent hole, 20-hollowed-out blood groove, 21-hematocrit test strip interface end, 22-bottom end. Detailed Implementation

[0046] The technical solution of this utility model will be further described below with reference to the accompanying drawings and specific embodiments. However, the following examples are merely simplified examples of this utility model and do not represent or limit the scope of protection of this utility model. The scope of protection of this utility model is determined by the claims.

[0047] Where specific techniques or conditions are not specified in the examples, they shall be performed in accordance with the techniques or conditions described in the literature in this field, or in accordance with the product instructions. Reagents or instruments whose manufacturers are not specified are all conventional products that can be purchased through legitimate channels.

[0048] In the description of this embodiment, the terms "upper," "lower," "left," and "right," etc., refer to the orientation or positional relationship shown in the accompanying drawings. They are used only for ease of description and simplification of operation, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model. In addition, the terms "first" and "second" are only used for distinction in description and have no special meaning.

[0049] Example 1

[0050] like Figure 1 The diagram shows the structural components of a detection device capable of performing hematocrit correction. The device includes a dry chemical test strip cover 1, a hematocrit test strip 2, a dry chemical test strip 3, and a dry chemical test strip cover 4.

[0051] The hematocrit test strip 2 is attached between the dry chemistry test strip cover 1 and the dry chemistry test strip 3, enabling simultaneous dry chemistry detection and hematocrit detection. The dry chemistry detection results can be calibrated using the hematocrit readings. The dry chemistry test strip cover 1 includes a sample application hole 10, a hematocrit test strip interface 21, and a bottom end 22. The hematocrit test strip interface 21 is 3 mm higher than the bottom end 22.

[0052] The dry chemical test paper holder cover 4 includes a 17-groove 3 and a handle 18. The dry chemical test paper 3 is placed in the 17-groove 3, which can serve to fix it in place.

[0053] Example 2

[0054] like Figure 2A front cross-sectional view of the detection device capable of hematocrit correction shows that the hematocrit test strip 2 forms a closed cavity 12 between the dry chemical test strip cover 1 and the dry chemical test strip 3, ensuring uniform flow of blood sample during dry chemical testing and preventing blood sample leakage. Simultaneously, the dry chemical test strip cover 1 is provided with a sample application port 10, through which the blood sample is added to the detection device. Since the sample application port 10 is above the gap 12, it ensures that the sample flows smoothly into the dry chemical test strip 3 and the hematocrit test strip 2.

[0055] from Figure 3 A side cross-sectional view of the detection device capable of hematocrit correction shows that the electrode of the hematocrit test strip 2 extends outside the outer casing. When the power supply is connected to the electrode, the hematocrit test strip 2 can perform hematocrit detection on the blood sample to be tested. The lower cover 4 of the dry chemical test strip casing includes detection holes 11. A detection device is connected to the detection holes 11 to realize the detection of the dry chemical test strip. The number of detection holes 11 depends on the actual dry chemical test strip detection.

[0056] Example 3

[0057] like Figure 4 The diagram shows the structural composition of the hematocrit test strip. The hematocrit test strip 2 includes, from top to bottom, double-sided adhesive 5, a hydrophilic membrane 6, double-sided adhesive 7, a hematocrit detection electrode 8, and double-sided adhesive 9. Specifically, the hydrophilic membrane 6 is bonded to the hematocrit detection electrode 8 using double-sided adhesive 7, and the hematocrit test strip 2 is bonded to the upper cover 1 and lower cover 4 of the dry chemical test strip casing using double-sided adhesive 5 and double-sided adhesive 9.

[0058] like Figure 5 As shown in the diagram of the hematocrit test strip, the double-sided adhesive 7 has a groove 1, and the hydrophilic membrane 6 has a groove 2 corresponding to the groove 1 on the double-sided adhesive 7. After the hydrophilic membrane 6 is attached to the double-sided adhesive 7, the grooves 1 and 2 combine to form an air escape hole. The position corresponding to the air escape hole is the motor assembly of the hematocrit test strip 2. This structure ensures that the blood sample flows into the motor assembly of the hematocrit test strip for hematocrit detection. Figure 6As shown, the double-sided tape 7 and the hydrophilic membrane 6 overlap to form a hollow blood groove 20 and an air escape hole 19. After adding the hematocrit test paper 2, when the blood sample to be tested is added to the sample well 10, due to the hydrophilic effect of the hydrophilic membrane 6 on the hematocrit test paper 2, the blood sample will be automatically drawn into the hematocrit test paper 2. After the instrument detects that the groove (13) on the hematocrit test paper 2 is full of blood sample, it will automatically detect the hematocrit of the blood sample. At the same time, the plasma in the blood sample permeates into the dry chemical test paper 3 and reacts. The instrument detects the signal on the reaction membrane. The instrument corrects the signal on the reaction membrane by the hematocrit result obtained by the hematocrit test paper. When the hematocrit of the blood sample is lower or higher than the standard value of 42% ± 2%, the instrument will calculate the corresponding compensation ratio based on the detected hematocrit signal. Then the instrument calculates the blood sample concentration on the reaction membrane based on the signal on the reaction membrane. Multiplying this blood sample concentration by the compensation ratio will give the final sample concentration, resulting in a more accurate test result.

[0059] Example 4

[0060] The detection device capable of performing hematocrit correction is configured according to... Figure 1 The diagram shows the structural composition of the detection device capable of hematocrit correction. After installation, the blood sample to be tested is added to the sample well 10. Part of the blood sample flows into the hematocrit detection electrode 8 through the adsorption of the hydrophilic membrane 6 for hematocrit detection, while the other part of the blood sample flows into the dry chemical test paper 3 through the gap 12. After the test is completed, the hematocrit result is used to calibrate the dry chemical test result, thereby obtaining a more accurate test result.

[0061] In summary, this invention achieves simultaneous detection of both dry chemical test paper and hematocrit by attaching an impedance method test paper to the top cover of the dry chemical test paper casing, and corrects the dry chemical test paper detection results using the hematocrit detection results.

[0062] The applicant declares that the above description is only a specific embodiment of the present utility model, but the protection scope of the present utility model is not limited thereto. Those skilled in the art should understand that any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present utility model fall within the protection and disclosure scope of the present utility model.

Claims

1. A hematocrit-correctable test device, comprising: The detection device comprises a dry chemical test paper card upper cover (1), a hematocrit test paper (2), a dry chemical test paper (3) and a dry chemical test paper card lower cover (4). The hematocrit test paper (2) comprises double-sided adhesive 1 (5), a hydrophilic membrane (6), double-sided adhesive 2 (7), a hematocrit detection electrode (8) and double-sided adhesive (9) from top to bottom. The dry chemical test paper card upper cover (1) comprises a sample addition hole (10), a hematocrit test paper interface end (21) and a bottom end (22). The hematocrit test paper interface end (21) is 2-8 mm higher than the bottom end (22). The dry chemical test paper card lower cover (4) comprises a detection hole (11).

2. The detection device of claim 1, wherein, The double-sided adhesive 2 (7) is provided with a groove 1 (13), and the groove 1 (13) is 0-5 mm wide and 0-5 mm long. The hydrophilic membrane (6) is provided with a groove 2 (14) at a position corresponding to the groove 1 (13) of the double-sided adhesive 2 (7), and the groove 2 (14) is 0-5 mm wide and 0-2 mm long.

3. The detection device of claim 2, wherein, The groove 1 (13) and the groove 2 (14) of the hydrophilic membrane (6) combine to form an escape hole (19) after the double-sided adhesive 2 (7) is attached.

4. The detection device of claim 1, wherein, The hematocrit test paper (2) is a hollow structure.

5. The detection device of claim 1, wherein, The dry chemical test paper card upper cover (1) and the hematocrit test paper (2) are attached to form a gap (12).

6. The detection device of claim 5, wherein, The sample addition hole (10) is located above the gap (12).

7. The detection device of claim 3, wherein The hematocrit detection electrode (8) comprises an electrode end (15) and a detection end (16). The escape hole (19) corresponds to the upper part of the detection end (16). The groove 1 (13) of the double-sided adhesive 2 (7) and the hydrophilic membrane (6) form a hollow blood groove (20).

8. The detection device of claim 1, wherein, The number of detection holes (11) is 1-5.

9. The detection device of claim 1, wherein, The dry chemical test paper card lower cover (4) is provided with a groove 3 (17). The dry chemical test paper (3) is fixed in the groove 3 (17).

10. The detection device of claim 1, wherein, The dry chemical test paper card lower cover (4) is provided with a handle (18).

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