Reagent card for combined test of comprehensive blood lipid indexes

Abstract

The utility model discloses a combined test reagent card for comprehensive blood lipid indexes. The combined test reagent card comprises a shell, and a quantitative sample adding module and a test strip which are arranged in the shell, the test strip comprises a bottom plate, and a sample pad, a detection pad and a sample absorption pad which are sequentially overlapped on the bottom plate; the blood fat indexes comprise four indexes of total cholesterol, triglyceride, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol; a detection line and a quality control line are arranged on the detection pad, the detection line is coated with specific capture antibodies aiming at the four indexes, and the quality control line is coated with haptens or antibodies capable of being combined with quality control detection antibodies aiming at the four indexes; the quantitative sample adding module is arranged corresponding to the sample pad and comprises a quantitative bin and a waste liquid bin which are communicated with each other, and flow guide fibers are arranged between the quantitative bin and the waste liquid bin. According to the utility model, the joint detection of four blood fat indexes can be realized, the cost consumption is reduced, and accurate sample adding can be realized under the condition that verified sample adding equipment and professional technicians are not needed.

Description

TECHNICAL FIELD

[0001] The utility model relates to the field of biotechnology diagnosis technology, especially to a comprehensive blood lipid index combined test reagent card. BACKGROUND

[0002] Blood lipids, as important metabolic substances of the human body, are mainly composed of cholesterol (20-30%), triglycerides (10-15%), phospholipids (45-50%), and free fatty acids (5-10%). Their physiological functions include: ① forming the core component of biological membranes; ② synthesizing steroid hormone precursors; ③ participating in bile acid metabolism; ④ storing and providing energy. According to the China Cardiovascular Health and Disease Report, the prevalence of dyslipidemia among people aged 18 and above in China is 40.4%, directly leading to 2.6 million deaths from cardiovascular and cerebrovascular diseases each year.

[0003] Pathological mechanisms of dyslipidemia:

[0004] Atherosclerosis: oxidized LDL-C is phagocytosed by macrophages to form foam cells, which are deposited in the intima of blood vessels to form lipid stripes. When HDL-C is <1.0 mmol / L, the reverse transport efficiency of cholesterol decreases by more than 50%, accelerating plaque formation;

[0005] Acute pancreatitis: when TG is >11.3 mmol / L, chylomicron accumulation in pancreatic capillaries triggers abnormal activation of pancreatic enzymes, and the incidence of severe pancreatitis increases by 12 times;

[0006] Fatty liver disease: TG deposition in liver cells >5% constitutes non-alcoholic fatty liver, accompanied by elevated ALT levels, and 25% of patients will progress to cirrhosis;

[0007] Thrombosis: hyperlipidemia upregulates PAI-1 expression by up to 300%, inhibits fibrinolytic system activity, and promotes abnormal platelet aggregation.

[0008] Currently, clinical detection of blood lipids usually involves at least the following four items:

[0009] TC (total cholesterol): as a core indicator of lipid metabolism, the normal value is 3.1-5.2 mmol / L. Its clinical value lies in: ① Atherosclerosis is an independent predictor, and for every 1 mmol / L increase, the risk of coronary heart disease increases by 35%; ② It is significantly positively correlated with apoB lipoprotein; ③ The China Adult Dyslipidemia Prevention and Control Guidelines list it as a basic detection item. Pathological elevation is seen in familial hypercholesterolemia, and reduction indicates malnutrition or liver dysfunction;

[0010] TG (triglyceride): energy metabolism marker, normal range 0.5-1.7 mmol / L. Clinical significance includes: ① acute pancreatitis early warning indicator; ② insulin resistance biomarker ③ major component of residual particles causing arteriosclerosis. Its diurnal fluctuation amplitude can reach 30%, and fasting detection has important diagnostic value.

[0011] LDL-C (low-density lipoprotein cholesterol): core risk factor for arteriosclerosis, ideal level <2.6 mmol / L. Clinical relevance is reflected in: ① dose-dependent positive correlation with coronary artery calcification score; ② each 1 mmol / L reduction can reduce the risk of major vascular events by 22%; ③ current lipid management guidelines prioritize intervention targets. Oxidatively modified sdLDL subtypes have a stronger effect on arteriosclerosis.

[0012] HDL-C (high-density lipoprotein cholesterol): cardiovascular protective factor, normal value for men 1.0-1.8 mmol / L, for women 1.2-1.9 mmol / L. Clinical value is manifested in: ① cholesterol reverse transport carrier; ② endothelial function regulator; ③ anti-inflammatory and antioxidant mediator. Epidemiology shows that for every 0.1 mmol / L increase in HDL-C, the risk of coronary heart disease decreases by 7-15%. Functional abnormalities are more pathologically significant than absolute value changes.

[0013] Necessity of four-marker joint detection: ① NCEP-ATP III guidelines emphasize that this four-marker combination is the core of seven-marker detection; ② joint analysis can calculate arteriosclerosis index (LDL-C / HDL-C) and non-HDL-C value; ③ the China Cholesterol Education Program states that simultaneous monitoring of multiple markers can increase the detection rate of metabolic syndrome by 38%; ④ provides multi-dimensional parameters for evaluating the efficacy of statins.

[0014] Currently, biochemical analyzers are commonly used for blood lipid detection, which has problems such as expensive equipment, long detection period, and the need for professional operation. Test strip detection can solve the above technical problems and is becoming an excellent replacement for biochemical analyzer detection, but still has the following technical problems:

[0015] ① Existing test strips are mostly single-factor detection, and multiple-factor detection uses multiple test strips, causing reagent and sample waste, consuming more materials and labor costs;

[0016] ② The test results of test strips are the test values of the added sample, and blood lipid items are sensitive to sample addition, so inaccurate sample addition can easily cause detection results to deviate, and accurate sample addition requires calibrated sample addition equipment and professional technical personnel.

[0017] Therefore, it is necessary to provide a comprehensive blood lipid index combined test reagent card to realize joint detection of blood lipid indexes and accurate sample adding without a certified sample adding device and professional technicians. Utility model content

[0018] To solve the above technical problems, the utility model discloses a comprehensive blood lipid index combined test reagent card, which can realize joint detection of four blood lipid indexes, reduce cost consumption and realize accurate sample adding without a certified sample adding device and professional technicians.

[0019] To achieve the above technical purposes and effects, the utility model realizes the following technical scheme:

[0020] A comprehensive blood lipid index combined test reagent card, comprising a shell, a quantitative sample adding module and a test strip, wherein the test strip comprises a bottom plate and a sample pad, a detection pad and a sample suction pad sequentially arranged on the bottom plate from front to back; the blood lipid indexes include four indexes of total cholesterol, triglyceride, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol; the detection pad is provided with a detection line and a quality control line, the detection line is coated with specific capture antibodies for the four indexes, and the quality control line is coated with a hapten or an antibody capable of being combined with a quality control detection antibody for the four indexes; the quantitative sample adding module is arranged corresponding to the sample pad and comprises a quantitative bin and a waste liquid bin, the quantitative bin and the waste liquid bin are communicated, and a flow guide fiber is arranged between the quantitative bin and the waste liquid bin.

[0021] Further, the shell comprises an upper clamping shell and a lower clamping shell, and the test strip is arranged in a space formed by the upper clamping shell and the lower clamping shell.

[0022] Further, the shell is provided with a viewing window corresponding to the position of the detection pad.

[0023] Further, the shell is provided with a sample adding port corresponding to the position of the sample pad.

[0024] Further, the position of the quantitative bin corresponds to the sample adding port.

[0025] Further, the bottom of the quantitative bin is a plastic film bottom, and after the plastic film bottom is pierced, the sample added in the quantitative bin can contact the sample pad.

[0026] Further, the inner wall of the quantitative bin is provided with a hydrophobic coating.

[0027] Further, the flow guide fiber is a glass fiber.

[0028] Further, the test strip is fixed on the lower clamping shell through a front fixing block and a rear fixing block arranged on the lower clamping shell.

[0029] Further, the reagent card further comprises a sample adding device for pricking the plastic film bottom of the quantitative bin, and the sample adding device is clamped on the sample adding port of the shell.

[0030] The present application has the following beneficial effects:

[0031] The present application realizes the combined detection of blood lipid indexes by one reagent card, and can quantitatively detect four indexes within 15 minutes, which is simple in operation, high in sensitivity, strong in specificity and accurate in result.

[0032] The present application is provided with a quantitative sample adding module, and the excess sample liquid in the quantitative bin can be guided to the waste liquid bin through the flow guide fiber, so that accurate sample adding can be realized without the need of a sample adding device and professional technicians, and the deviation of the detection result caused by inaccurate sample adding in the detection process is avoided. BRIEF DESCRIPTION OF DRAWINGS

[0033] Figure 1 It is a top view of the comprehensive blood lipid index combined detection reagent card.

[0034] Figure 2 It is a sectional structure schematic view of the comprehensive blood lipid index combined detection reagent card.

[0035] Figure 3 It is an exploded structure view of the shell in the comprehensive blood lipid index combined detection reagent card.

[0036] Figure 4 It is a structure schematic view of the quantitative sample adding module in the comprehensive blood lipid index combined detection reagent card.

[0037] Figure 5 It is a structure schematic view of the test paper strip in the comprehensive blood lipid index combined detection reagent card.

[0038] In the figure, 1: shell, 11: upper clamping shell, 111: sample adding port, 112: viewing window, 12: lower clamping shell, 13: front fixed block, 14: rear fixed block; 2: quantitative sample adding module, 21: quantitative bin, 22: waste liquid bin, 23: communication port, 24: flow guide fiber; 3: test paper strip, 31: sample pad, 32: detection pad, 321: detection line, 322: quality control line, 33: sample absorbing pad; 4: sample adding device. DETAILED DESCRIPTION

[0039] The preferred embodiments of the present application are described in detail below with reference to the accompanying drawings, so that the advantages and features of the present application can be more easily understood by those skilled in the art, and the protection scope of the present application is more clearly defined.

[0040] In the description of this utility model, it should be understood that the terms "front", "rear", "left", "right", "up", "down", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this utility model and simplifying the description, 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.

[0041] like Figures 1 to 5 The present invention relates to a preferred embodiment of a combined blood lipid index test kit, wherein the test object is a sample processing solution to be tested; the kit includes a housing 1, a quantitative sample addition module 2 installed in the housing 1, and a test strip 3.

[0042] like Figure 5 As shown, the test strip 3 includes a base plate and a sample pad 31, a detection pad 32, and an absorbent pad 33, which are sequentially overlapped on the base plate from front to back. The sample pad 31 is a glass fiber pad or a non-woven fabric pad, the detection pad 32 is made of nitrocellulose membrane, the absorbent pad 33 is made of absorbent filter paper, and the base plate is a PVC board.

[0043] The blood lipid indicators to be detected include four indicators: total cholesterol, triglycerides, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. The sample processing solution contains fluorescently labeled (in this embodiment, time-resolved fluorescent microspheres) specific detection antibodies and quality control antibodies targeting the four indicators. The detection pad 32 has four detection lines 321 and one quality control line 322, with the quality control line 322 close to the sample absorption pad 33. The four detection lines 321 are respectively coated with specific capture antibodies targeting the four indicators, and the quality control line 322 is coated with haptens or antibodies capable of binding to the quality control antibodies targeting the four indicators.

[0044] It should be noted that the specific capture antibodies for TC (total cholesterol), TG (triglycerides), LDL-C (low-density lipoprotein cholesterol), and HDL-C (high-density lipoprotein cholesterol) used to coat detection line 321 can be either polyclonal or monoclonal antibodies. The antibody used to coat control line 322 can be a hapten, or goat anti-mouse IgG, goat anti-chicken IgY, or goat anti-rabbit IgG.

[0045] like Figure 3 As shown, the outer shell 1 includes an upper retaining shell 11 and a lower retaining shell 12. The front end of the inner side of the lower retaining shell 12 is provided with a front fixing block 13, and the rear end of the inner side of the lower retaining shell 12 is provided with a rear fixing block 14. The test strip 3 is fixedly installed in the space formed by the upper retaining shell 11 and the lower retaining shell 12 through the front fixing block 13 and the rear fixing block 14.

[0046] The upper clasp 11 and lower clasp 12 are injection molded from medical-grade ABS material. After assembly, the dimensions of the upper clasp 11 and lower clasp 12 can be (60-80mm) × (15-25mm) × (4-6mm), with a preferred embodiment being 80mm × 20mm × 5mm. The upper clasp 11 is provided with a viewing window 112 corresponding to the position of the detection pad. The viewing window 112 is made of plastic film with a light transmittance of 90%. The area of ​​the orthographic projection of the viewing window 112 onto the detection pad 32 should be larger than the area formed by the detection line, the control line, and the interval between them, to facilitate clearer and more direct observation.

[0047] The upper casing 11 is also provided with a sample inlet 111, the position of which corresponds to the position of the sample pad 31.

[0048] like Figure 4 As shown, the quantitative sample loading module 2 is configured corresponding to the sample pad 31, and includes a quantitative chamber 21 and a waste liquid chamber 22. The quantitative chamber 21 is located above the sample pad 31 and corresponds to the position of the sample loading port 111. The quantitative chamber 21 and the waste liquid chamber 22 are connected by a connecting port 23, and the connecting port 23 is provided with a guide fiber 24. The bottom of the quantitative chamber 21 is a plastic film bottom, and the other parts are made of ABS material. The inner wall surface of the quantitative chamber 21 is treated with a hydrophobic coating. In this embodiment, the precise volume of the quantitative chamber 21 is 75 μL, and the volume error does not exceed 10%. The volume of the waste liquid chamber 22 is greater than 200 μL to ensure that excess liquid will not leak out of the waste liquid chamber. When the sample processing liquid in the quantitative chamber 21 exceeds 75 μL, the excess liquid is automatically introduced into the waste liquid chamber 22 through the guide fiber 24. In this embodiment, the guide fiber 24 is glass fiber.

[0049] In addition, the reagent card is equipped with a pipette 4 for piercing the bottom of the plastic film of the quantitative chamber 21. The pipette 4 includes a top cover and a sampling needle disposed on the top cover. The top cover is injection molded from ABS material, and the sampling needle is made of 304 stainless steel. The pipette 4 is snapped into the sampling port 111 of the upper housing 11. By pressing down on the pipette 4, the sampling needle of the pipette 4 can pierce the bottom of the plastic film of the quantitative chamber 21.

[0050] The method of using the reagent card of this utility model is as follows:

[0051] (1) Take out the reagent card stored at room temperature, open the sealed bag, and place it flat on the testing platform;

[0052] (2) Take out the pipette 4 and place it on the table or in another suitable storage location with the needle facing up. Be careful not to contaminate the needle.

[0053] (3) Use a pipette or dropper to take the sample to be tested and drop it into the quantitative chamber 21 through the sample inlet 111, at least 5 drops;

[0054] (4) Wait for 2 minutes for the excess liquid to flow into the waste liquid chamber 22;

[0055] (5) Insert the sample applicator 4 into the sample inlet 111 and press it down, the needle of the sample applicator 4 will pierce the plastic film bottom of the quantitative chamber 21, and the sample to be tested will contact the sample pad 31, and the immunochromatography reaction will start on the reagent strip 3;

[0056] (6) After waiting for 15 minutes, insert the reagent card into the dry fluorescence immunoassay analyzer with the viewing window 112 facing up;

[0057] (7) The dry fluorescence immunoassay analyzer automatically analyzes and calculates TC (total cholesterol), TG (triglyceride), LDL-C (low-density lipoprotein cholesterol), and HDL-C (high-density lipoprotein cholesterol) according to the pre-set standard curve, and outputs the quantitative results;

[0058] (8) If the quality control line cannot detect a fluorescence signal or the fluorescence signal is lower than the set value, the instrument will report a failed experiment and needs to be retested.

[0059] It is obvious to those skilled in the art that the present application is not limited to the details of the above exemplary embodiments, and can be implemented in other specific forms without departing from the spirit or essential characteristics of the present application. Therefore, from any point of view, the embodiments should be considered as exemplary and non-limiting, and the scope of the present application is defined by the appended claims rather than the above description, and therefore all changes falling within the meaning and scope of the equivalent elements of the claims are intended to be included in the present application.

[0060] In addition, it should be understood that although the present specification is described in terms of embodiments, not every embodiment contains only one independent technical solution, and the description of the specification is only for the sake of clarity, and those skilled in the art should consider the specification as a whole, and the technical solutions in each embodiment can be appropriately combined to form other embodiments that those skilled in the art can understand.

Claims

1. A reagent card for combined detection of blood lipid indexes, characterized in that, The quantitative sample adding module and the test strip are arranged in the shell. The blood lipid indexes include total cholesterol, triglyceride, low density lipoprotein cholesterol and high density lipoprotein cholesterol.

2. The reagent card for combined detection of blood lipid indexes according to claim 1, characterized in that, The shell includes an upper clamping shell and a lower clamping shell, and the test strip is arranged in a space formed by the upper clamping shell and the lower clamping shell.

3. The reagent card for combined detection of blood lipid indexes according to claim 1, characterized in that, The shell is provided with a viewing window corresponding to the position of the detection pad.

4. The reagent card for combined detection of blood lipid indexes according to claim 1, characterized in that, The shell is provided with a sample adding port corresponding to the position of the sample pad.

5. The reagent card for combined detection of blood lipid indexes according to claim 4, characterized in that, The position of the quantitative tank corresponds to the sample adding port.

6. The reagent card for combined detection of blood lipid indexes according to claim 5, characterized in that, The bottom of the quantitative tank is a plastic film bottom.

7. The reagent card for combined detection of blood lipid indexes according to claim 1 or 6, characterized in that, The inner wall of the quantitative tank is provided with a hydrophobic coating.

8. The reagent card for combined detection of blood lipid indexes according to claim 1, characterized in that, The flow guide fiber is a glass fiber.

9. The reagent card for combined detection of blood lipid indexes according to claim 2, characterized in that, The test strip is fixed to the lower clamping shell through a front fixing block and a rear fixing block arranged on the lower clamping shell.

10. The reagent card for combined detection of blood lipid indexes according to claim 6, characterized in that, The shell is provided with a sample adding port corresponding to the position of the sample pad. The bottom of the quantitative tank is a plastic film bottom. The inner wall of the quantitative tank is provided with a hydrophobic coating. The flow guide fiber is a glass fiber. The test strip is fixed to the lower clamping shell through a front fixing block and a rear fixing block arranged on the lower clamping shell. The shell is provided with a sample adding port corresponding to the position of the sample pad. The bottom of the quantitative tank is a plastic film bottom. The inner wall of the quantitative tank is provided with a hydrophobic coating. The flow guide fiber is a glass fiber. The test strip is fixed to the lower clamping shell through a front fixing block and a rear fixing block arranged on the lower clamping shell. The shell is provided with a sample adding port corresponding to the position of the sample pad. The bottom of the quantitative tank is a plastic film bottom. The inner wall of the quantitative tank is provided with a hydrophobic coating. The flow guide fiber is a glass fiber. The test strip is fixed to the lower clamping shell through a front fixing block and a rear fixing block arranged on the lower clamping shell. The shell is provided with a sample adding port corresponding to the position of the sample pad. The bottom of the quantitative tank is a plastic film bottom. The inner wall of the quantitative tank is provided with a hydrophobic coating. The flow guide fiber is a glass fiber. The test strip is fixed to the lower clamping shell through a front fixing block and a rear fixing block arranged on the lower clamping shell. The shell is provided with a sample adding port corresponding to the position of the sample pad. The bottom of the quantitative tank is a plastic film bottom. The inner wall of the quantitative tank is provided with a hydrophobic coating. The flow guide fiber is a glass fiber. The test strip is fixed to the lower clamping shell through a front fixing block and a rear fixing block arranged on the lower clamping shell. The shell is provided with a sample adding port corresponding to the position of the sample pad. The bottom of the quantitative tank is a plastic film bottom. The inner wall of the quantitative tank is provided with a hydrophobic coating. The flow guide fiber is a glass fiber. The test strip is fixed to the lower clamping shell through a front fixing block and a rear fixing block arranged on the lower clamping shell. The shell is provided with a sample adding port corresponding to the position of the sample pad. The bottom of the quantitative tank is a plastic film bottom. The inner wall of the quantitative tank is provided with a hydrophobic coating. The flow guide fiber is a glass fiber. The test strip is fixed to the lower clamping shell through a front fixing block and a rear fixing block arranged on the lower clamping shell. The shell is provided with a sample adding port corresponding to the position of the sample pad. The bottom of the quantitative tank is a plastic film bottom. The inner wall of the quantitative tank is provided with a hydrophobic coating. The flow guide fiber is a glass fiber. The test strip is fixed to the lower clamping shell through a front fixing block and a rear fixing block arranged on the lower clamping shell. The shell is provided with a sample adding port corresponding to the position of the sample pad. The bottom of the quantitative tank is a plastic film bottom. The inner wall of the quantitative tank is provided with a hydrophobic coating. The flow guide fiber is a glass fiber. The test strip is fixed to

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