Diluent for blood cell detection

Abstract

The invention discloses a diluent for blood cell detection, the diluent comprises a buffer solution, an osmotic pressure regulator, a preservative and a stabilizer, the concentration of the buffer solution is 5-100 mM, the osmotic pressure regulator accounts for 0.1-2% by mass, the preservative accounts for 0.01-0.05% by mass, the stabilizer accounts for 0.0001-0.05% by mass of the diluent, and the pH value of the diluent is 7.4-7.8; according to the invention, the buffer solution, the osmotic pressure regulator and the preservative in the range are compounded, so that the formed diluent has excellent chemical and physical properties; by adding the stabilizer, the diluent can keep stable for a long time, the influence of micron-sized bubbles on detection is effectively reduced, and the detection accuracy and precision are improved.

Description

Technical Field

[0001] The invention relates to the technical field of biological sample detection, and in particular to a diluent for blood cell detection. Background Art

[0002] At present, the common blood cell analyzers on the market are equipped with special diluents. Diluents and hemolytic agents are the most commonly used reagents for blood analyzers in medical tests. They are key reagents for determining hemoglobin (Hb), white blood cells (WBC), platelet (PLT) counts or classifications, etc. Before blood cell determination, the whole blood sample must be diluted with diluent at a certain ratio outside or inside the instrument. In order to destroy all red blood cells, 1 ml of hemolytic agent (lyse) is added to rupture the red blood cell membrane, release hemoglobin, and leave only a tiny remnant of the red blood cell membrane. The target item is then counted and tested by the instrument.

[0003] However, the existing diluents need to be matched with different diluents for different test items, that is to say, the universality of the existing diluents is not very high, which will lead to increased production costs and use costs; and the diluents are easily impacted, vibrated, etc. during transportation or dropping, resulting in bubbles in the diluent, especially micron-level bubbles, and especially 1-10μm-level bubbles, and the bubbles are difficult to eliminate, affecting the stability of the diluent and may affect the test results. Summary of the invention

[0004] The technical problem to be solved by the present invention is that, in view of the defects in the prior art, the present invention provides a diluent for blood cell detection.

[0005] The technical solution adopted by the present invention to solve its technical problem is: a diluent for blood cell detection, the diluent comprising a buffer, an osmotic pressure regulator, a preservative and a stabilizer, the concentration of the buffer is 5-100mM, the mass percentage of the osmotic pressure regulator in the diluent is 0.1-2%, the mass percentage of the preservative in the diluent is 0.01-0.05%, the mass percentage of the stabilizer in the diluent is 0.0001-0.05%, and the pH of the diluent is 7.4-7.8.

[0006] Furthermore, it is preferred that the stabilizer comprises at least one of polysorbate and polyoxypropylene oxyethylene glycerol ether.

[0007] Furthermore, it is preferred that the stabilizer is a mixture of polysorbate and polyoxypropylene oxyethylene glycerol ether, and the ratio of the two is (1-3):(1-5).

[0008] Furthermore, it is preferred that the polysorbate is at least one of Tween 20, Tween 80, Tween 21, Tween 40, Tween 60, Tween 61, Tween 81 and Tween 85.

[0009] Furthermore, it is preferred that the stabilizer is a mixture of Tween 20, Tween 80 and polyoxypropylene oxyethylene glycerol ether, and the ratio of the three is 1:(1-5):(1-5).

[0010] Furthermore, it is preferred that the average molecular weight of the polyoxypropylene oxyethylene glycerol ether is 1000 to 15000.

[0011] Furthermore, it is preferred that the average molecular weight of the polyoxypropylene oxyethylene glycerol ether is 2000-6000.

[0012] Further, it is preferred that the polyoxypropylene oxyethylene glycerol ether is poly(propylene glycol)-block-poly(ethylene glycol)-block-poly(propylene glycol), with an average molecular weight of 2000; or, poly(propylene glycol)-block-poly(ethylene glycol)-block-poly(propylene glycol), with an average molecular weight of 2700; or, poly(propylene glycol)-block-poly(ethylene glycol)-block-poly(propylene glycol), with an average molecular weight of 3300; or, poly(ethylene glycol)-b1 or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), with an average molecular weight of 5800; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), with an average molecular weight of 2000; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol) (ethylene glycol), with an average molecular weight of 1100; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), with an average molecular weight of 14600; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), with an average molecular weight of 1900; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), with an average molecular weight of 2900; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), with an average molecular weight of 2800; poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), with an average molecular weight of 12600; poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), with an average molecular weight of 8400; or a mixture of the above substances.

[0013] Furthermore, it is preferred that the mass percentage of the stabilizer is 0.0001 to 0.0045% of the diluent.

[0014] Furthermore, preferably, the concentration of the buffer solution is 10-50 mM, the mass percentage of the osmotic pressure regulator in the diluent is 0.5-0.9%, the mass percentage of the preservative in the diluent is 0.01-0.02%, and the mass percentage of the stabilizer in the diluent is 0.002-0.003%.

[0015] Furthermore, it is preferred that the buffer is one or more of phosphate buffer, borate buffer, Tris buffer, citrate buffer, carbonate buffer, and GOOD'S series buffer.

[0016] Furthermore, it is preferred that the osmotic pressure regulator is one or more of sodium chloride, potassium chloride, sodium sulfate, and potassium sulfate.

[0017] Furthermore, it is preferred that the preservative is one or more of sodium azide, ProClin series, Casone series, penicillin, and gentamicin.

[0018] The present invention has the following beneficial effects: the diluent for blood cell detection provided by the present invention is suitable for biological sample detection of different detection items, has good universality, and reduces production cost and use cost; the diluent has good system stability, can maintain a stable pH environment, is an isotonic solution, can dilute blood specimens well, and will not damage the blood specimens; the addition of a stabilizer will not react with the original system in the diluent, and will not affect the detection result of blood cells; during the transportation or falling of the diluent, the stabilizer added to the diluent is adsorbed on the bubble liquid film surface of the micron-sized bubbles, and should be able to replace (i.e. squeeze out) the foaming agent molecules on the liquid surface, and these stabilizers ... The stabilizer itself is not sufficient to form a tight adsorption film on the surface of the solution to achieve the effect of inhibiting foaming; and the stabilizer itself can quickly spread and disperse on the surface of the system, dispersing its anti-foaming substances in the system, which can significantly reduce the surface tension of the bubble system liquid, so as to achieve the effect of quickly breaking bubbles and inhibiting the generation of bubbles. It has a long-term (at least two years) anti-foaming and defoaming effect while ensuring the accuracy of blood cell analysis test results (including but not limited to PLT), ensuring the long-term stability of the test kit, greatly shortening the time required for the test kit to be left standing after transportation, improving the accuracy and precision of the test, and facilitating end-customer operations and clinical sample testing. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The above and other objects, features and advantages of the present invention will become more apparent by describing in more detail exemplary embodiments of the present invention with reference to the accompanying drawings.

[0020] Figure 1 is the WBC correlation test result of Example 1 of the present invention and the reference diluent;

[0021] Figure 2 is the PLT correlation test result of Example 1 of the present invention and the reference dilution;

[0022] Figure 3 is the RBC correlation test result of Example 1 of the present invention and the reference diluent;

[0023] Figure 4 HGB correlation test results of Example 1 of the present invention and the reference dilution;

[0024] Figure 5 HCT correlation test results of Example 1 of the present invention and the reference diluent;

[0025] Figure 6 MCV correlation test results of Example 1 of the present invention and the reference dilution. DETAILED DESCRIPTION

[0026] In order to have a clearer understanding of the technical features, purposes and effects of the present invention, the present invention will be further described in detail below in conjunction with embodiments. The embodiments are only used to explain the present invention and do not constitute a limitation on the protection scope of the present invention.

[0027] The present invention provides a diluent for blood cell detection. The diluent comprises a buffer solution, an osmotic pressure regulator, a preservative and a stabilizer. The concentration of the buffer solution in the diluent is 5 to 100 mM, the mass percentage of the osmotic pressure regulator in the diluent is 0.1 to 2%, the mass percentage of the preservative in the diluent is 0.01 to 0.05%, the mass percentage of the stabilizer in the diluent is 0.0001 to 0.05%, and the pH of the diluent is 7.4 to 7.8.

[0028] In the present invention, the concentration of the buffer solution can be 5mM, 10mM, 15mM, 20mM, 25mM, 30mM, 35mM, 40mM, 45mM, 50mM, 55mM, 60mM, 65mM, 70mM, 75mM, 80mM, 85mM, 90mM, 95mM and 100mM, etc., without specific limitation. Controlling the pH of the diluent within this range can effectively control the pH of the diluent to be stable within the target range, that is, the pH is 7.4 to 7.8, and the buffer solution and pH range within this concentration range will not have an adverse effect on the determination of blood cells in the sample to be detected. Controlling the concentration of the buffer solution within this range can improve the detection accuracy and precision.

[0029] The present invention controls the mass percentage of the osmotic pressure regulator in the diluent to be 0.1-2%, such as the mass percentage of the osmotic pressure regulator in the diluent is 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.8%, 1.0%, 1.2%, 1.4%, 1.5%, 1.6%, 1.8% and 2.0%, etc., without specific limitation. Controlling the osmotic pressure regulator within this range can make the diluent become an isotonic solution, prevent damage to blood cells, thereby avoiding affecting the detection of blood cells, and improving the detection accuracy and precision.

[0030] The present invention controls the dosage of the stabilizer to be 0.0001-0.05% of the mass percentage of the diluent, such as 0.0001%, 0.0002%, 0.0003%, 0.0004%, 0.0005%, 0.0006%, 0.0007%, 0.0008%, 0.0009%, 0.001%, 0.0015%, 0.002%, 0.0025%, 0.003%, 0.0035%, 0.004%, 0.0045%, 0.005%, 0.008%, 0.01%, 0.02%, 0.03%, 0.04% and 0.05%, etc., without specific limitation ; It can be understood that the proportion of the stabilizer in the diluent is extremely small, that is to say, the amount of the stabilizer input is controlled within this range so that it will not interact with the original system, will not affect the detection of blood cell items, and can well play the role of stabilizing the diluent, can reduce the generation of micron-level bubbles and can achieve the effect of quickly breaking micron-level bubbles, especially for micron-level bubbles of 1 to 10μm; if the amount of the stabilizer is too small, it will not achieve a good anti-foaming and defoaming effect; if the amount of the stabilizer is too large, it may affect the original system, change the physical and chemical properties of the original system, affect the detection of blood cell items, and cannot achieve a good anti-foaming and defoaming effect.

[0031] In the present invention, the addition of preservatives can prevent the diluent from losing efficacy due to microbial contamination, which is beneficial to prolonging the shelf life of the diluent. The mass percentage of the preservative in the diluent is controlled to be 0.01-0.5%, such as 0.01%, 0.02%, 0.04%, 0.05%, 0.06%, 0.08%, 0.1%, 0.15%, 0.2%, 0.25%, 0.3%, 0.35%, 0.4%, 0.45% and 0.5%, etc., and is not specifically limited. Controlling the amount of the preservative within this range can effectively prevent the diluent from losing efficacy due to microbial contamination, which is beneficial to prolonging the shelf life of the diluent.

[0032] The present invention uses the buffer solution, osmotic pressure regulator, stabilizer and preservative within the above range to compound the above components, and the formed diluent is suitable for various biological sample detections, has universal applicability, and has excellent chemical and physical properties; the addition of the stabilizer can enable the diluent to maintain long-term stability, effectively reduce the impact of micron-level bubbles on detection, and improve detection accuracy and precision.

[0033] The diluent for blood cell detection provided by the present invention is suitable for biological sample detection of different detection items and has good universality; the system has good stability and can maintain a stable pH environment. It is an isotonic solution and can dilute blood specimens well without damaging the blood specimens; the addition of a stabilizer does not react with the original system in the diluent and will not affect the detection result of blood cells; during the transportation or falling of the diluent, the stabilizer added to the diluent is adsorbed on the bubble liquid film surface of micron-sized bubbles and should be able to replace (i.e. squeeze out) the foaming agent molecules on the liquid surface. These stabilizers themselves are The surface of the solution is not sufficient to form a tight adsorption film to achieve the effect of inhibiting foaming; and the stabilizer itself can quickly spread and disperse on the surface of the system, dispersing its anti-foaming substances in the system, which can significantly reduce the surface tension of the bubble system liquid, so as to achieve the effect of quickly breaking bubbles and inhibiting the generation of bubbles. It has a long-term (at least two years) anti-foaming and defoaming effect while ensuring the accuracy of blood cell analysis test results (including but not limited to PLT), ensures the long-term stability of the test kit, greatly shortens the time required for the test kit to be left standing after transportation, improves the accuracy and precision of the test, and is beneficial to end-customer operations and clinical sample testing.

[0034] In a specific embodiment, the preferred stabilizer includes at least one of polysorbate and polyoxypropylene oxyethylene glycerol ether. The addition of polysorbate and / or polyoxypropylene oxyethylene glycerol ether will not react with other components in the diluent, or the effect that occurs is negligible, and will not change the physical, chemical or biological properties of the original system, and will not damage the blood sample, and will not affect the detection results of blood cells; secondly, the addition of polysorbate and / or polyoxypropylene oxyethylene glycerol ether can be adsorbed on the bubble liquid film surface of micron-sized bubbles, and can quickly replace (i.e. squeeze out) the foaming agent molecules on the liquid surface; these stabilizers themselves are not enough to form a tight adsorption film on the surface of the solution, and the stabilizers themselves can significantly reduce the local surface tension to achieve the effect of quickly breaking bubbles and inhibiting the generation of bubbles, and have excellent diffusion performance, and are stably dispersed in the diluent for a long time, so that it has a long-term (at least two years) anti-foaming and defoaming effect, ensuring the long-term stability of the diluent, greatly shortening the time required for the diluent to be left to stand after transportation, improving the accuracy and precision of the detection, and facilitating the operation of end customers and clinical sample testing.

[0035] In a specific embodiment, the preferred stabilizer is a mixture of polysorbate and polyoxypropylene oxyethylene glycerol ether, and the two can be mixed in any proportion. Preferably, the ratio of the two is (1-3): (1-5), such as 1:5, 1:4, 1:3, 1:2, 2:3, 1:1, 3:5, 3:2, 2:1, 3:1, etc., without specific limitation. By compounding polysorbate and polyoxypropylene oxyethylene glycerol ether, the defoaming effect on the diluent is better, the defoaming is faster, the anti-foaming effect on the diluent is better, and the stability of the diluent is better and longer-lasting, which is beneficial to improving the detection accuracy and precision; further, and by compounding the two, a smaller amount of stabilizer can be used to reach an effective amount, so that the total amount of stabilizer in the diluent is 0.0001-0.04% by mass to achieve better stabilization effect, defoaming, anti-foaming effect and longer duration (at least 2.2 years).

[0036] In a specific embodiment, the polysorbate is preferably at least one of Tween 20 (CAS: 9005-64-5), Tween 80 (CAS: 9005-65-6), Tween 40 (CAS: 9005-66-7), Tween 60 (CAS: 9005-67-8), Tween 61, Tween 81 and Tween 85 (CAS: 9005-70-3). The above polysorbate stabilizers have diffusion, solubilization, stabilization and other effects, so that the system has a good dispersion effect and promotes the dissolution of other substances, but does not interact with other components, or the effect is very small, so small that it can be ignored; secondly, the above polysorbate stabilizers will not have an adverse effect on the blood sample; and can effectively reduce the surface tension of the liquid in the diluent, thereby achieving the effect of quickly breaking bubbles and inhibiting the generation of bubbles, and also making the system have a good dispersion effect, so that it has a long-term (at least two years) anti-foaming and defoaming effect.

[0037] In a specific embodiment, the preferred stabilizer is a mixture of Tween 20, Tween 80 and polyoxypropylene oxyethylene glycerol ether, and the three can be mixed in any proportion, preferably in a ratio of 1: (1-5): (1-5), such as 1:1:5, 1:1:1, 1:3:1, 1:4:1, 1:2:2, 1:2:3, 1:2:4, 1:1:5, 1:3:3, 1:4:2, 1:1:1, 1:5:1, 1:5:2, 1:5:3, 1:5:4, 1:5:5, etc., without limitation. The three are compounded to achieve a good dispersion effect of the system, maintain long-term dispersion, achieve a better defoaming effect on the diluent, and achieve a faster defoaming effect, and achieve a better anti-foaming effect on the diluent, so that the stability of the diluent is better and longer-lasting, which is beneficial to improving the detection accuracy and precision, and the cost is low; further, through the compounding of the three, a smaller amount of stabilizer input can be used to achieve an effective amount, so that the total amount of stabilizer in the diluent is 0.0001-0.03% by mass, which can achieve better stabilization effect, defoaming effect, and anti-foaming effect, and is longer-lasting (at least 2.5 years).

[0038] In a specific embodiment, the average molecular weight of polyoxypropylene oxyethylene glyceryl ether is preferably 1000-15000, and the CAS of polyoxypropylene oxyethylene glyceryl ether is 9003-11-6. The polyoxypropylene oxyethylene glyceryl ethers selected in the present invention are all finished products available on the market, which are used directly without treatment; the molecular weight of polyoxypropylene oxyethylene glyceryl ether will affect the defoaming and antifoaming effects of the diluent. If the molecular weight of polyoxypropylene oxyethylene glyceryl ether is too small, it will not achieve a good antifoaming and defoaming effect; if the molecular weight of polyoxypropylene oxyethylene glyceryl ether is too large, it may affect the original system, change the physical and chemical properties of the original system, affect the detection of blood cell items, and cannot achieve a good antifoaming and defoaming effect. In the present invention, the average molecular weight of the polyoxypropylene oxyethylene glycerol ether is preferably 1000-15000, and the average molecular weight of the polyoxypropylene oxyethylene glycerol ether can be 1000, 1500, 2000, 2500, 3000, 4000, 5000, 6000, 7000, 8000, 9000, 10000, 11000, 12000, 13000, 14000, 15000, etc., without specific limitation. The polyoxypropylene oxyethylene glycerol ether with the above average molecular weight can be selected to form a tight adsorption film on the surface of the solution, and the stabilizer itself can significantly reduce the local surface tension to achieve the effect of quickly breaking bubbles and inhibiting the generation of bubbles, so that it has a long-term (at least two years) anti-foaming and defoaming effect, ensures the long-term stability of the diluent, greatly shortens the time required for the diluent to stand for use after transportation, and improves the accuracy and precision of the detection.

[0039] In a specific embodiment, it is further preferred that the average molecular weight of the polyoxypropylene oxyethylene glyceryl ether is 2000-6000, and the average molecular weight of the polyoxypropylene oxyethylene glyceryl ether may be 2000, 2100, 2200, 2300, 2400, 2500, 2600, 2700, 2800, 2900, 3000, 3500, 4000, 4500, 5000, 5500, 6000, etc., without specific limitation. By selecting the polyoxypropylene oxyethylene glyceryl ether with the above average molecular weight, a smaller amount (about 0.0% by mass of the diluent system) can be used. 01%~0.035%) can achieve the stabilizing effect, defoaming effect and anti-foaming effect on the diluent and can maintain long-term effect (at least 2.1 years); the use of polyoxypropylene oxyethylene glycerol ether with the above average molecular weight can make it insufficient to form a tight adsorption film on the surface of the solution, and the stabilizer itself can significantly reduce the local surface tension to achieve the effect of quickly breaking bubbles and inhibiting the generation of bubbles, so that it has a long-term (at least 2.1 years) anti-foaming and defoaming effect, ensures the long-term stability of the diluent, greatly shortens the time required for the diluent to stand still after transportation, and improves the accuracy and precision of the detection.

[0040] In a specific embodiment, the polyoxypropylene oxyethylene glycerol ether is preferably poly(propylene glycol)-block-poly(ethylene glycol)-block-poly(propylene glycol), with an average molecular weight of 2000; or, poly(propylene glycol)-block-poly(ethylene glycol)-block-poly(propylene glycol), with an average molecular weight of 2700; or, poly(propylene glycol)-block-poly(ethylene glycol)-block-poly(propylene glycol), with an average molecular weight of 3300; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), with an average molecular weight of 4400; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol). or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), with an average molecular weight of 5800; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), with an average molecular weight of 2000; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), with an average molecular weight of 1100; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), with an average molecular weight of 14600; or, poly(ethylene glycol)-block-poly(propylene glycol) )-block-poly(ethylene glycol) with an average molecular weight of 1900; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol) with an average molecular weight of 2900; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol) with an average molecular weight of 2800; poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol) with an average molecular weight of 12600; poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol) ), with an average molecular weight of 8400; or a mixture of the above substances; the above polyoxypropylene oxyethylene glycerol ethers are all commercially available products and can be used after purchase without being treated. The selection of the above stabilizers can prevent the solution surface of the diluent from being insufficient to form a tight adsorption film, and the stabilizer itself can significantly reduce the local surface tension to achieve the effect of quickly breaking bubbles and inhibiting the generation of bubbles, so that it has a long-term anti-foaming and defoaming effect, ensures the long-term stability of the diluent, greatly shortens the time required for the diluent to stand still after transportation, and improves the accuracy and precision of the detection.

[0041] In a specific embodiment, the preferred mass percentage of the stabilizer in the diluent is 0.0001-0.0045%. For example, 0.0001%, 0.00013%, 0.00015%, 0.00018%, 0.0002%, 0.00023%, 0.00025%, 0.00028%, 0.0003%, 0.00032%, 0.00035%, 0.00038%, 0.0004%, 0.00042%, 0.00045%, 0.00048%, 0.0005%, 0.0006%, 0.0007%, 0.0008%, 0.0009%, 0.001%, 0.0015%, 0.0016%, 0.0017%, 0.0018%, 0.0019%, 0.010%, 0.011%, 0.012%, 0.013%, 0.014%, 0.015%, 0.016%, 0.017%, 0.018%, 0.019%, 0.019 0.002%, 0.0025%, 0.003%, 0.0035%, 0.0037%, 0.0040%, 0.0045%, etc., are not specifically limited; it can be understood that in the present embodiment, the proportion of the stabilizer in the diluent is very, very small, that is to say, the addition of such a small amount of stabilizer makes it possible for the stabilizer to have no effect on other components in the system, nor to damage the blood sample, nor to affect the detection of blood cell items; and the addition of the stabilizer within this range can play a role in stabilizing the system better, can reduce the generation of micron-sized bubbles and can achieve the effect of quickly breaking the micron-sized bubbles.

[0042] In a specific embodiment, the concentration of the buffer solution is preferably 10-50 mM, the mass percentage of the osmotic pressure regulator in the diluent is 0.5-0.9%, the mass percentage of the preservative in the diluent is 0.01-0.02%, and the mass percentage of the stabilizer in the diluent is 0.002-0.003%. The present invention uses the buffer solution, osmotic pressure regulator, preservative, and stabilizer in the above proportions to compound the above components so that the formed diluent has excellent chemical and physical properties; the addition of the stabilizer can keep the diluent stable for a long time, and can effectively reduce the influence of micron-level bubbles on detection for at least 2.1 years, thereby improving the detection accuracy and precision.

[0043] In a specific embodiment, the preferred buffer is one or more of phosphate buffer, borate buffer, Tris buffer, citrate buffer, carbonate buffer, and GOOD'S series buffer. The addition of the above buffers can stabilize the pH of the diluent within the target range, has a good effect of stabilizing the system, and will not cause adverse effects on the determination of blood cells in the sample to be tested. Different buffers are selected according to different test items, and controlling the concentration of the buffer within the public range can improve the accuracy and precision of the test.

[0044] In a specific embodiment, the preferred osmotic pressure regulator is one or more of sodium chloride, potassium chloride, sodium sulfate, and potassium sulfate. The selection of the above osmotic pressure regulators can make the diluent an isotonic solution without destroying the blood sample, which is beneficial to the subsequent dilution of the blood sample and improves the accuracy and precision of the detection.

[0045] In a specific embodiment, the preferred preservative is one or more of sodium azide, ProClin series, Kathon series, penicillin, and gentamicin. By selecting the dosage of the above preservatives within this range, the diluent can be effectively prevented from becoming ineffective due to microbial contamination, which is beneficial for extending the storage period of the diluent.

[0046] In some specific embodiments, the filling amount of the diluent is not more than 100mL, such as 1mL, 2mL, 3mL, 4mL, 5mL, 10mL, 15mL, 20mL, 25mL, 30mL, 35mL, 40mL, 45mL, 50mL, 55mL, 60mL, 65mL, 70mL, 75mL, 80mL, 85mL, 90mL, 95mL and 100mL, etc., without specific limitation; and the technical scheme of the present invention can ensure the long-term anti-foaming and defoaming effects in the case of a small filling amount of the diluent, ensure the long-term stability of the test kit, greatly shorten the time required for the test kit to stand after transportation, especially for impedance detection of blood cell projects, which can greatly improve the detection accuracy and precision, and is beneficial to terminal customer operation and clinical sample testing.

[0047] Furthermore, it is preferred that the filling amount of the diluent is not greater than 5 mL, that is, it can be 5 mL, 4.5 mL, 4 mL, 3.5 mL, 3 mL, etc., without specific restrictions. In conventional blood cell detection, diluent within 5 mL is sufficient for detection and analysis. Limiting the filling amount within this range can not only ensure sufficient detection dosage, but also make the volume of the kit smaller and save dosage; on the other hand, affected by the external force and the degree of mixing of air, the smaller the amount of diluent in the process of transportation or falling, the more likely it is to produce micron-level bubbles due to impact, vibration, etc., that is, the bubbles more likely to be generated during the collision process of the small amount of diluent are not conventional bubbles visible to the naked eye, and their size is similar to that of PLT, which is invisible to the naked eye and difficult to eliminate, and affects the detection results of the blood cell project. The technical solution of the present invention can ensure the long-term anti-foaming and defoaming effects when the diluent is in a very small amount, thereby ensuring the long-term stability of the kit, greatly shortening the time required for the kit to be left to stand after transportation, improving the accuracy and precision of the detection, and facilitating the operation of end customers and clinical sample testing.

[0048] Example 1

[0049] A diluent for blood cell detection, the diluent comprising a buffer, an osmotic pressure regulator, a preservative and a stabilizer, and the specific formula is shown in the table below.

[0050] Table 1. Formula of diluent of Example 1

[0051]

[0052]

[0053] Note: In this embodiment, Tris buffer can be replaced by at least one of phosphate buffer, borate buffer, citrate buffer, carbonate buffer, GOOD'S series buffer or a mixture with Tris buffer; sodium chloride can be replaced by at least one of potassium chloride, sodium sulfate, potassium sulfate or a mixture with sodium chloride; Tween 20 can be replaced by at least one of polysorbate and polyoxypropylene oxyethylene glycerol ether described in the foregoing text of the present invention; sodium azide can be replaced by at least one of ProClin series, Kasson series, penicillin, gentamicin or a mixture with sodium azide; replacement of the above substances does not affect the results of this embodiment.

[0054] Example 2

[0055] A diluent for blood cell detection, the diluent comprising a buffer, an osmotic pressure regulator, a preservative and a stabilizer, and the specific formula is shown in the table below.

[0056] Table 2. Formula of diluent of Example 2

[0057]

[0058] Example 3

[0059] A diluent for blood cell detection, the diluent comprising a buffer, an osmotic pressure regulator, a preservative and a stabilizer, and the specific formula is shown in the table below.

[0060] Table 3. Formula of diluent of Example 3

[0061]

[0062] Example 4

[0063] A diluent for blood cell detection, the diluent comprising a buffer, an osmotic pressure regulator, a preservative and a stabilizer, and the specific formula is shown in the table below.

[0064] Table 4. Formula of diluent of Example 4

[0065]

[0066] Example 5

[0067] A diluent for blood cell detection, the diluent comprising a buffer, an osmotic pressure regulator, a preservative and a stabilizer, and the specific formula is shown in the table below.

[0068] Table 5. Formula of diluent of Example 5

[0069]

[0070]

[0071] Comparative Example 1

[0072] The difference between Comparative Example 1 and Example 1 is that no stabilizer is added to the diluent, and the rest is the same as Example 1.

[0073] Comparative Example 2

[0074] The difference between Comparative Example 2 and Example 1 is that the amount of the stabilizer added to the diluent is 0.055% by mass of the diluent, and the rest is the same as Example 1.

[0075] The diluents of Examples 1 to 5 and Comparative Examples 1 to 2 were used for transportation, and after standing for 24 hours, the following tests were performed: blank, accuracy, repeatability, stability, and clinical relevance tests.

[0076] 1. Blank test and its results

[0077] After the diluents of Examples 1 to 5 are transported back, the blank samples are tested 5 times, and the test results should meet the requirements of the following table:

[0078] Table 6. Blank count requirements

[0079] project Blank count requirement WBC <![CDATA[≤0.20×10 9 / L]]> RBC <![CDATA[≤0.02×10 12 / L]]> HGB ≤1g / L PLT <![CDATA[≤5×10 9 / L]]> HCT ≤0.5％

[0080] Table 7. Example 1 Transport return blank count results

[0081] Serial number WBC RBC HGB HCT PLT 1 0 0 0 0 9 2 0 0 0 0 7 3 0 0 0 0 1 4 0 0 0 0 6 5 0 0 0 0 0

[0082] Table 8. Example 2 Transport return blank count results

[0083]

[0084]

[0085] Table 9. Example 3 Transport return blank count results

[0086] Serial number WBC RBC HGB HCT PLT 1 0.04 0 0 0 2 2 0 0 2 0 0 3 0 0 1 0 1 4 0 0 0 0 1 5 0.01 0 0 0 1

[0087] Table 10. Example 4 Transport return blank count results

[0088] Serial number WBC RBC HGB HCT PLT 1 0 0 3 0 2 2 0 0 0 0 1 3 0 0 0 0 1 4 0 0 0 0 1 5 0.03 0 0 0 2

[0089] Table 11. Example 5 Transport return blank count results

[0090] Serial number WBC RBC HGB HCT PLT 1 0 0 0 0 1 2 0 0 0 0 0 3 0 0 3 0 1 4 0 0 0 0 0 5 0 0 0 0 1

[0091] Table 12. Comparative Example 1 Transport Return Blank Count Results

[0092] Serial number WBC RBC HGB HCT PLT 1 0.11 0.01 0 0.1 107 2 0.23 0.01 0 0.1 139 3 0.1 0.01 0 0 69 4 0.21 0.02 0 0.1 135 5 0.14 0.01 0 0.1 115

[0093] From the test results in Tables 7 to 12, it can be seen that the blank count results of Examples 1 to 5 of the present invention meet the requirements after being transported and allowed to stand for 24 hours, while the background test PLT result of Comparative Example 1 without adding a stabilizer is very high after being allowed to stand for 24 hours and fails to meet the standard requirements and cannot be used for clinical sample testing.

[0094] 2. Repeatability test and its results

[0095] After the diluents of Examples 1 to 5 and Comparative Examples 1 to 2 were transported back, two fresh samples were tested 10 times each. The mean value (X) and standard deviation (SD) of the test results were calculated according to formulas (1) and (2), and the coefficient of variation (CV) was calculated according to formula (4). The test requirements and test results are shown in Tables 13 to 25. The test results should meet the requirements of the following table:

[0096] Formula (1):

[0097] Where: ——average value of test results; x i ——The actual measured value each time; n——The number of tests; i——The test serial number; B——Relative deviation; SD——Standard deviation; CV is the coefficient of variation.

[0098] Table 13. Repeatability test requirements

[0099]

[0100] Table 14. Repeatability test results of Example 1

[0101]

[0102]

[0103] Table 15. Repeatability test results of Example 1 2

[0104] Serial number WBC RBC HGB PLT HCT MCV 1 9.52 5.11 132 263 37.6 73.5 2 9.33 5.08 133 252 37.2 73.3 3 9.24 5.05 133 256 37.1 73.4 4 9.66 5.11 134 247 37.7 73.7 5 9.18 5.05 133 256 37.1 73.4 6 9.45 5.07 132 259 37.2 73.5 7 9.33 5.1 133 270 37.4 73.5 8 9.57 5.03 133 266 36.9 73.4 9 9.31 5.06 132 260 37.2 73.6 10 9.47 5.1 133 264 37.5 73.5 Mean 9.406 5.076 132.8 259.3 37.29 73.48 SD 0.153 0.028 0.632 6.848 0.251 0.114 CV 1.62％ 0.56％ 0.48％ 2.64％ 0.67％ 0.15％

[0105] Table 16. Repeatability test results of Example 2 1

[0106]

[0107]

[0108] Table 17. Repeatability test results of Example 2

[0109] Serial number WBC RBC HGB PLT HCT MCV 1 9.49 5.03 130 271 37.3 74.2 2 9.39 5.09 131 266 37.8 74.2 3 9.21 5.01 129 264 37.2 74.2 4 9.5 5.04 130 279 37.4 74.2 5 9.28 4.99 130 266 37.1 74.3 6 9.19 5.02 128 268 37.3 74.4 7 9.28 4.96 129 271 36.8 74.2 8 9.27 4.93 129 272 36.7 74.4 9 9.03 4.96 129 268 36.8 74.1 10 9 5.02 129 275 37.4 74.4 Mean 9.264 5.005 129.4 270 37.18 74.26 SD 0.169 0.046 0.843 4.570 0.339 0.107 CV 1.82％ 0.93％ 0.65％ 1.69％ 0.91％ 0.14％

[0110] Table 18. Repeatability test results of Example 3 1

[0111] Serial number WBC RBC HGB PLT HCT MCV 1 9.86 5.24 160 282 43.1 82.3 2 9.82 5.2 157 285 42.6 81.9 3 9.86 5.27 160 285 43.3 82.2 4 9.74 5.23 157 285 43 82.2 5 9.78 5.24 160 274 43.2 82.4 6 9.84 5.2 159 271 42.6 82 7 9.64 5.19 159 282 42.7 82.3 8 9.8 5.12 157 271 41.9 81.9 9 9.84 5.15 159 285 42.3 82.1 10 9.67 5.17 157 281 42.5 82.1 Mean 9.785 5.201 158.5 280.1 42.72 82.14 SD 0.078 0.046 1.354 5.840 0.437 0.171 CV 0.80％ 0.88％ 0.85％ 2.08％ 1.02％ 0.21％

[0112] Table 19. Repeatability test results of Example 3 2

[0113] Serial number WBC RBC HGB PLT HCT MCV 1 7.42 4.07 127 194 33 81.1 2 7.56 4.09 126 189 33.2 81.1 3 7.55 4.08 127 193 33 80.9 4 7.26 4.05 127 188 32.9 81.3 5 7.46 4.09 126 197 33.1 80.9 6 7.69 4.03 128 183 32.7 81.1 7 7.52 4.01 125 190 32.4 80.7 8 7.38 4.02 124 188 32.6 81 9 7.49 4.07 125 197 32.9 80.7 10 7.41 4.03 126 199 32.7 81.1 Mean 7.474 4.054 126.1 191.8 32.85 80.99 SD 0.117 0.030 1.197 5.051 0.246 0.191 CV 1.57％ 0.74％ 0.95％ 2.63％ 0.75％ 0.24％

[0114] Table 20. Repeatability test results of Example 4 1

[0115] Serial number WBC RBC HGB PLT HCT MCV 1 9.67 5.23 159 279 43.3 82.8 2 9.74 5.27 158 287 43.6 82.8 3 9.78 5.23 157 281 43.2 82.6 4 9.66 5.2 157 281 43 82.8 5 9.66 5.26 158 282 43.7 83 6 9.47 5.17 157 285 42.8 82.8 7 9.41 5.19 158 281 43 82.8 8 9.49 5.18 157 269 42.8 82.8 9 9.45 5.17 158 289 42.8 82.8 10 9.19 5.12 155 279 42.4 82.8 Mean 9.552 5.202 157.4 281.3 43.06 82.8 SD 0.182 0.046 1.075 5.458 0.398 0.094 CV 1.90％ 0.88％ 0.68％ 1.94％ 0.92％ 0.11％

[0116] Table 21. Repeatability test results of Example 4 2

[0117]

[0118]

[0119] Table 22. Repeatability test results of Example 5 1

[0120] Serial number WBC RBC HGB PLT HCT MCV 1 7.07 5.48 180 303 45.7 83.4 2 7.12 5.41 180 296 45.2 83.7 3 6.9 5.37 179 301 44.8 83.5 4 7.15 5.36 181 306 44.7 83.5 5 6.87 5.39 179 290 45 83.5 6 7.13 5.37 179 302 44.8 83.4 7 7.18 5.35 180 294 44.6 83.4 8 6.95 5.37 179 290 45 83.8 9 6.97 5.37 178 287 44.9 83.6 10 6.89 5.32 179 292 45.2 85 Mean 7.023 5.379 179.4 296.1 44.99 83.68 SD 0.1194 0.0425 0.8433 6.5226 0.3178 0.4826 CV 1.70％ 0.79％ 0.47％ 2.20％ 0.71％ 0.58％

[0121] Table 23. Repeatability test results of Example 5 2

[0122]

[0123]

[0124] Table 24. Comparative Example 1 Repeatability Test Results 1

[0125] Serial number WBC RBC HGB PLT HCT MCV 1 8.21 4.71 146 661 38.9 82.7 2 8.41 4.86 145 520 40.3 82.9 3 9.92 5.66 160 538 44.1 78 4 8.5 4.71 145 461 39.9 84.7 5 7.95 4.79 147 486 39.6 82.7 6 8.52 5.07 147 443 41.9 82.6 7 8.77 4.7 149 626 39.3 83.8 8 8.64 4.42 146 339 42.3 95.6 9 8.37 4.93 144 419 40.8 82.8 10 8.89 5.2 148 587 42.8 82.3 Mean 8.618 4.905 147.7 508 40.99 83.81 SD 0.5306 0.3421 4.5717 98.8928 1.7110 4.4921 CV 6.16％ 6.98％ 3.10％ 19.47％ 4.17％ 5.36％

[0126] Table 25. Comparative Example 2 Repeatability Test Results 2

[0127]

[0128]

[0129] From the test results in Tables 13 to 25, it can be found that Examples 1 to 5 of the present invention were tested after transportation, and the repeatability performance met the requirements, while the background test PLT results of Comparative Example 1 without adding stabilizer and Comparative Example 2 with added amount exceeding the range disclosed in the present invention were very high and failed to meet the standard requirements and could not be used for clinical sample testing.

[0130] 3. Accuracy test and its results

[0131] Fresh samples were measured using Examples 1 to 5 and Comparative Examples 1 and 2, respectively, and the test was repeated 3 times. The relative deviation was calculated according to the above formulas (1) and (3). The test requirements and test results are shown in Tables 26 to 33. The test results should meet the requirements of the following table:

[0132] Formula (3):

[0133] Where:

[0134] T——sample reference machine result;

[0135] B——Relative deviation.

[0136] Table 26. Accuracy requirements

[0137]

[0138] Table 27. Accuracy results of Example 1

[0139] Serial number WBC RBC HGB HCT MCV PLT 1 6.47 4.82 123 38.2 79.3 361 2 6.35 4.96 124 39.2 79.1 365 3 6.36 4.82 124 37.4 77.6 388 Mean 6.39 4.87 123.67 38.27 78.67 371.33 Target value 6.59 5.02 127 40.3 80.3 394 Relative deviation -2.98％ -3.05％ -2.62％ -5.05％ -2.03％ -5.75％

[0140] Table 28. Accuracy results of Example 2

[0141] Serial number WBC RBC HGB HCT MCV PLT 1 4.54 4.46 113 36.7 82.3 300 2 4.63 4.37 118 36.3 83.2 296 3 4.58 4.28 114 35.7 83.4 285 Mean 4.58 4.37 115.00 36.23 82.97 293.67 Target value 4.54 4.47 119 37.8 84.6 309 Relative deviation 0.95％ -2.24％ -3.36％ -4.14％ -1.93％ -4.96％

[0142] Table 29. Accuracy results of Example 3

[0143] Serial number WBC RBC HGB HCT MCV PLT 1 6.46 5.06 134 40.2 79.6 317 2 6.39 5.16 132 41.5 80.4 270 3 6.39 5.22 136 41.9 80.3 257 Mean 6.41 5.15 134.00 41.20 80.10 281.33 Target value 6.52 5.24 136 43.5 83 288 Relative deviation -1.64％ -1.78％ -1.47％ -5.29％ -3.49％ -2.31％

[0144] Table 30. Accuracy results of Example 4

[0145] Serial number WBC RBC HGB HCT MCV PLT 1 5.95 4.52 135 43.7 90.6 283 2 5.86 4.44 142 44.4 90 281 3 5.88 4.54 137 45.2 89.7 294 Mean 5.90 4.50 138.00 44.43 90.10 286.00 Target value 5.66 4.55 139 42.1 92.5 274 Relative deviation 4.18％ -1.10％ -0.72％ 5.54％ -2.59％ 4.38％

[0146] Table 31. Accuracy results of Example 5

[0147] Serial number WBC PLT RBC HGB HCT MCV 1 7.25 5.16 163 47.8 87.6 216 2 7.7 5.21 157 50.7 88 206 3 7.28 5.19 161 48 89.1 214 Mean 7.41 5.19 160.33 48.83 88.23 212.00 Target value 7.17 5.19 159 46.3 89.2 208 Relative deviation 3.35％ -0.06％ 0.84％ 5.47％ -1.08％ 1.92％

[0148] Table 32. Comparative Example 1 Accuracy Results

[0149] Serial number WBC PLT RBC HGB HCT MCV 1 8.21 4.71 146 661 38.9 82.7 2 8.41 4.86 145 520 40.3 82.9 3 9.92 5.66 160 538 44.1 78 Mean 8.85 5.08 150.33 573.00 41.10 81.20 Target value 8.3 5.1 136 275 42.9 84.1 Relative deviation 6.59％ -0.46％ 10.54％ 108.36％ -4.20％ -3.45％

[0150] Table 33. Comparative Example 2 Accuracy Results

[0151]

[0152] From the test results of Tables 27 to 33, it can be found that Examples 1 to 5 of the present invention were tested after transportation and the repeatability performance met the requirements, while Comparative Example 1 in which no stabilizer was added and Comparative Example 2 in which the amount of stabilizer added exceeded the range disclosed in the present invention had very high background test PLT results that failed to meet the standard requirements and could not be used for clinical sample testing.

[0153] 4. Clinically relevant tests and their results

[0154] A group of clinical samples (40 cases) covering the linear range were tested simultaneously using the reference diluent (a commercially available preparation purchased from Mindray, with a batch number of M-5D) and Example 1. The measured values ​​of the reference diluent were taken as the x-axis and the measured values ​​of Example 1 were taken as the y-axis. Linear regression analysis was performed. The test results are shown in Table 34 and Attached Figures 1 to 6 The test results should meet the requirements: the slope k of the linear regression equation is between 0.9 and 1.1 and the correlation coefficient R 2 ≥0.95.

[0155] Table 34. Clinical relevance test results of Example 1

[0156]

[0157]

[0158] From the test results in Table 34, it is found that the results of the diluent of Example 1 and the reference diluent in the test of clinical samples were subjected to linear regression analysis. The slope k and the correlation R of the linear regression equation are 2 All of them meet the requirements, which proves that the diluent in Example 1 has a good correlation with the commercially available diluent.

[0159] 5. Stability test

[0160] The dilutions of Examples 1 to 5 were placed in a 56° C. heat accelerated environment for 19 days (equivalent to a two-year shelf life at room temperature), and then transported for testing. After being transported back, the background and accuracy were tested.

[0161] (1) Blank test

[0162] Table 35. Example 1 accelerated transport blank test results

[0163] Sample No. WBC RBC HGB HCT PLT 1 0 0 0 0 2 2 0 0 0 0 2 3 0 0 0 0 1 4 0 0 0 0 3 5 0 0 0 0 2

[0164] Table 36. Example 2 accelerated transport blank test results

[0165] Sample No. WBC RBC HGB HCT PLT 1 0 0 0 0 3 2 0 0 0 0 5 3 0 0 0 0 3 4 0 0 0 0 4 5 0 0 0 0 4

[0166] Table 37. Example 3 Accelerated Transport Blank Test Results

[0167]

[0168]

[0169] Table 38. Example 4 Accelerated Transport Blank Test Results

[0170] Sample No. WBC RBC HGB HCT PLT 1 0 0 0 0 3 2 0 0 0 0 2 3 0 0 0 0 3 4 0 0 0 0 2 5 0 0 0 0 2

[0171] Table 39. Example 5 accelerated transport blank test results

[0172] Sample No. WBC RBC HGB HCT PLT 1 0 0 0 0 7 2 0 0 0 0 9 3 0 0 0 0 5 4 0 0 0 0 7 5 0 0 0 0 7

[0173] (2) Accuracy test

[0174] Table 40. Accuracy test results of Example 1

[0175] Sample No. WBC RBC HGB HCT MCV PLT 3 10.31 5.23 164 48.4 92.5 289 2 10.33 5.53 165 51.5 93.2 290 1 10.34 5.58 166 52.7 94.5 298 Mean 10.33 5.45 165.00 50.87 93.40 292.33 Target value 10.64 5.32 160 48.9 93.7 309 Relative deviation -2.94％ 2.38％ 3.13％ 4.02％ -0.32％ -5.39％

[0176] Table 41. Accuracy test results of Example 2

[0177]

[0178]

[0179] Table 42. Accuracy test results of Example 3

[0180] Sample No. WBC RBC HGB HCT MCV PLT 3 5.55 5.46 162 50.3 92.2 251 2 5.43 5.45 161 50.9 93.3 266 1 5.48 5.77 162 52.1 90.3 266 Mean 5.49 5.56 161.67 51.10 91.93 261.00 Target value 5.69 5.69 165 49.6 93.3 248 Relative deviation -3.57％ -2.28％ -2.02％ 3.02％ -1.46％ 5.24％

[0181] Table 43. Accuracy test results of Example 4

[0182] Sample No. WBC RBC HGB HCT MCV PLT 3 10.56 5.33 168 52.4 93 312 2 10.36 5.36 167 52.7 94.5 322 1 10.12 5.28 163 49 92.9 309 Mean 10.35 5.32 166.00 51.37 93.47 314.33 Target value 9.84 5.22 160 48.9 93.7 309 Relative deviation 5.15％ 1.98％ 3.75％ 5.04％ -0.25％ 1.73％

[0183] Table 44. Accuracy test results of Example 5

[0184] Sample No. WBC RBC HGB HCT MCV PLT 3 10.66 5.99 169 53.2 88.8 289 2 10.63 6.06 174 53.9 89 299 1 10.45 6.2 170 55.2 89.1 316 Mean 10.58 6.08 171.00 54.10 88.97 301.33 Target value 10.6 5.8 168 51.9 89.5 307 Relative deviation -0.19％ 4.89％ 1.79％ 4.24％ -0.60％ -1.85％

[0185] It can be seen from Tables 35 to 44 that the diluents of Examples 1 to 5 of the present invention are placed at 56° C. for 19 days of thermal acceleration and transported, and the precision and accuracy of the diluents of the present invention meet the requirements, that is, the diluents of the present invention can meet the use requirements within at least a two-year validity period.

[0186] The above data and accompanying drawings show that the relevant performance tests were carried out using the diluent of the present invention, and the results obtained all met the acceptance criteria. The feasibility and rationality of the present invention are verified by the above specific embodiments, which are only individual embodiments that can be selected by the present invention, but are not limited to this. For those skilled in the art, all changes, modifications and substitutions made according to the scope of the patent application of the present invention should be included in the scope of the claims of this patent and belong to the protection scope of the present invention.

[0187] It can be understood that the above embodiments only express the preferred implementation modes of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the patent scope of the present invention. It should be pointed out that, for ordinary technicians in this field, the above technical features can be freely combined without departing from the concept of the present invention, and several deformations and improvements can be made, which all belong to the protection scope of the present invention. Therefore, all equivalent changes and modifications made to the scope of the claims of the present invention should belong to the coverage of the claims of the present invention.

Claims

1. A diluent for blood cell detection, characterized in that: The diluent includes a buffer solution, an osmotic pressure regulator, a preservative and a stabilizer. The concentration of the buffer solution is 5 to 100 mM, the mass percentage of the osmotic pressure regulator in the diluent is 0.1 to 2%, the mass percentage of the preservative in the diluent is 0.01 to 0.05%, the mass percentage of the stabilizer in the diluent is 0.0001 to 0.05%, and the pH of the diluent is 7.4 to 7.

8.

2. The diluent for blood cell detection according to claim 1, characterized in that: The stabilizer includes at least one of polysorbate and polyoxypropylene oxyethylene glycerol ether.

3. The diluent for blood cell detection according to claim 2, characterized in that: The stabilizer is a mixture of polysorbate and polyoxypropylene oxyethylene glycerol ether, and the ratio of the two is (1-3): (1-5).

4. The diluent for blood cell detection according to claim 2, characterized in that: The polysorbate is at least one of Tween 20, Tween 80, Tween 40, Tween 60, Tween 61, Tween 81 and Tween 85.

5. The diluent for blood cell detection according to claim 4, characterized in that: The stabilizer is a mixture of Tween 20, Tween 80 and polyoxypropylene oxyethylene glycerol ether, and the ratio of the three is 1:(1-5):(1-5).

6. The diluent for blood cell detection according to claim 2, characterized in that: The average molecular weight of the polyoxypropylene oxyethylene glycerol ether is 1000-15000.

7. The diluent for blood cell detection according to claim 2, characterized in that: The polyoxypropylene oxide ethylene glycerol ether is poly(propylene glycol)-block-poly(ethylene glycol)-block-poly(propylene glycol), with an average molecular weight of 2000; or, poly(propylene glycol)-block-poly(ethylene glycol)-block-poly(propylene glycol), with an average molecular weight of 2700; or, poly(propylene glycol)-block-poly(ethylene glycol)-block-poly(propylene glycol), with an average molecular weight of 3300; or, poly(ethylene glycol)-block-poly (propylene glycol)-block-poly(ethylene glycol), with an average molecular weight of 4400; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), with an average molecular weight of 5800; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), with an average molecular weight of 2000; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol) ), with an average molecular weight of 1100; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), with an average molecular weight of 14600; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), with an average molecular weight of 1900; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), with an average molecular weight of 2900; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), with an average molecular weight of 2800; poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), with an average molecular weight of 12600; poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), with an average molecular weight of 8400; or a mixture of the above substances.

8. The diluent for blood cell detection according to claim 1, characterized in that: The mass percentage of the stabilizer is 0.0001 to 0.0045% of the diluent.

9. The diluent for blood cell detection according to claim 1, characterized in that: The concentration of the buffer solution is 10-50 mM, the mass percentage of the osmotic pressure regulator in the diluent is 0.5-0.9%, the mass percentage of the preservative in the diluent is 0.01-0.02%, and the mass percentage of the stabilizer in the diluent is 0.002-0.003%.

10. The diluent for blood cell detection according to any one of claims 1 to 9, characterized in that: The buffer is one or more of phosphate buffer, borate buffer, Tris buffer, citrate buffer, carbonate buffer, and GOOD'S series buffer; the osmotic pressure regulator is one or more of sodium chloride, potassium chloride, sodium sulfate, and potassium sulfate; the preservative is one or more of sodium azide, ProClin series, Casone series, penicillin, and gentamicin.

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