Diluent for blood cell testing

Abstract

This 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 mass percentage of the osmotic pressure regulator is 0.1–2%, the mass percentage of the preservative is 0.01–0.05%, the mass percentage of the stabilizer is 0.0001–0.05%, and the pH of the diluent is 7.4–7.8. By using the buffer solution, osmotic pressure regulator, and preservative within the above range, this invention combines the above components to form a diluent with excellent chemical and physical properties. The addition of the stabilizer enables the diluent to maintain long-term stability, effectively reducing the influence of micron-sized bubbles on detection and improving detection accuracy and precision.

Description

Technical Field

[0001] This invention relates to the field of biological sample detection technology, and in particular to a diluent for blood cell detection. Background Technology

[0002] Currently, most commercially available blood cell analyzers come with their own dedicated diluents. Diluents and lysing agents are the most commonly used reagents in blood analyzers for medical testing, and are crucial for determining hemoglobin (Hb), white blood cell (WBC), and platelet (PLT) counts or differentials. Before performing blood cell tests, the whole blood sample must be diluted with diluent at a certain ratio, either externally or internally, to completely destroy the red blood cells. Then, 1 ml of lysing agent is added to rupture the red blood cell membrane, releasing hemoglobin and leaving only a tiny residual portion of the red blood cell membrane. The target count is then performed by the instrument.

[0003] However, existing diluents require different diluents for different testing items, meaning that the universality of existing diluents is not very high. This will lead to increased production and usage costs. Furthermore, diluents are easily subjected to impacts and vibrations during transportation or dropping, which can cause bubbles to form in the diluent, especially micron-sized bubbles, particularly those in the 1-10μm range. These bubbles are difficult to eliminate, affecting the stability of the diluent and potentially impacting the test results. Summary of the Invention

[0004] The technical problem to be solved by the present invention is to provide a diluent for blood cell detection, which addresses the deficiencies in the prior art.

[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, wherein the concentration of the buffer is 5-100 mM, 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, the stabilizer preferably includes at least one of polysorbate and polyoxypropylene ethylene glycerol ether.

[0007] Further, the stabilizer is preferably a mixture of polysorbate and polyoxypropylene ethylene glycerol ether in a ratio of (1-3):(1-5).

[0008] Further, the polysorbate is preferably at least one of Tween 20, Tween 80, Tween 21, Tween 40, Tween 60, Tween 61, Tween 81 and Tween 85.

[0009] Further, the stabilizer is preferably a mixture of Tween 20, Tween 80 and polyoxypropylene ethylene glycerol ether, in a ratio of 1:(1-5):(1-5).

[0010] Furthermore, the average molecular weight of the polyoxypropylene ethylene glycerol ether is preferably 1000 to 15000.

[0011] Furthermore, the average molecular weight of the polyoxypropylene ethylene glycerol ether is preferably 2000 to 6000.

[0012] Further, preferably, the polyoxypropylene 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)-bl ock-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). 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] Further, it is preferred that the mass percentage of the stabilizer is 0.0001 to 0.0045% of the diluted solution.

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

[0015] Further, the buffer solution is preferably one or more of the following: phosphate buffer, borate buffer, Tris buffer, citrate buffer, carbonate buffer, and GOOD'S series buffers.

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

[0017] Furthermore, the preservative is preferably one or more of sodium azide, ProClin series, Kathon 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 projects, has good universality, and reduces production and usage costs; moreover, the diluent system has good stability, can maintain a stable pH environment, is an isotonic solution, can effectively dilute blood samples, and will not damage the blood samples; the addition of stabilizers will not interact with the original system in the diluent and will not affect the blood cell detection results; during the transportation or drop of the diluent, the stabilizers added to the diluent are adsorbed on the surface of the bubble liquid film of micron-sized bubbles, and should be able to replace (i.e., displace) the foaming agent molecules on the liquid surface. The stabilizer itself is insufficient to form a tight adsorption film on the solution surface to achieve the effect of foam suppression; however, the stabilizer itself can quickly spread and disperse on the surface of the system, dispersing its antifoaming substances in the system, which can significantly reduce the surface tension of the liquid in the foam system, thereby achieving the effect of rapid bubble breakage and inhibiting bubble generation. While ensuring the accuracy of blood cell analysis test results (including but not limited to PLT), it has a long-lasting (at least two years) antifoaming and defoaming effect, ensuring the long-term stability of the kit, greatly reducing the standing time required after the kit is transported, improving the accuracy and precision of the test, and benefiting end-customer operation and clinical sample testing. Attached Figure Description

[0019] The above and other objects, features and advantages of the present invention will become more apparent from the more detailed description of exemplary embodiments thereof in conjunction with the accompanying drawings.

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

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

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

[0023] Figure 4 HGB correlation test results between Example 1 of this invention and the reference diluent;

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

[0025] Figure 6 The MCV correlation test results of Example 1 of this invention and the reference diluent. Detailed Implementation

[0026] To provide a clearer understanding of the technical features, objectives, and effects of this invention, the invention will be further described in detail below with reference to embodiments. These embodiments are only used to explain the invention and do not constitute a limitation on the scope of protection of this invention.

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

[0028] In this 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., and there is no specific limitation. Controlling the concentration within this range can effectively control the pH of the diluent to be stable within the target range, that is, pH 7.4 to 7.8. Moreover, 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 tested. 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% to 2%, such as 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 any specific limitation. Controlling the osmotic pressure regulator within this range can make the diluent an isotonic solution, preventing damage to blood cells, thereby avoiding affecting the detection of blood cells and improving the accuracy and precision of the detection.

[0030] The present invention controls the amount of stabilizer added to be 0.0001% to 0.05% of the mass percentage of the diluted solution, 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 limitations. It is understandable that the stabilizer constitutes a very small proportion of the diluent. This means that controlling the amount of stabilizer within this range ensures that it will not interact with the original system. This way, it will not affect the detection of hematology results, but it will still effectively stabilize the diluent, reduce the generation of micron-sized bubbles, and rapidly break them up, especially effective for bubbles of 1–10 μm. If the amount of stabilizer is too small, it will not achieve a good antifoaming effect. If the amount of stabilizer is too large, it may affect the original system, altering its physical and chemical properties, affecting the detection of hematology results, and also failing to achieve a good antifoaming effect.

[0031] In this invention, the addition of preservatives prevents the diluent from becoming ineffective due to microbial contamination, thus extending the shelf life of the diluent. The mass percentage of the preservative in the diluent is controlled to be 0.01% to 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. No specific limit is imposed. Controlling the amount of preservative within this range effectively prevents the diluent from becoming ineffective due to microbial contamination, thereby extending the shelf life of the diluent.

[0032] This invention combines the above-mentioned components, including buffer solutions, osmotic pressure regulators, stabilizers, and preservatives, to form a diluent suitable for the detection of various biological samples. It has universality and excellent chemical and physical properties. The addition of stabilizers enables the diluent to maintain long-term stability, effectively reducing the impact of micron-sized bubbles on detection and improving detection accuracy and precision.

[0033] The diluent for blood cell detection provided by this invention is suitable for biological sample detection in various testing projects, exhibiting good versatility. Furthermore, the system demonstrates good stability, maintaining a stable pH environment and being an isotonic solution, effectively diluting blood samples without damaging them. The addition of stabilizers does not interact with the original system in the diluent and will not affect the blood cell detection results. During transport or drop, the stabilizers added to the diluent adsorb onto the surface of the micron-sized bubble film, effectively replacing (i.e., displacing) foaming agent molecules on the liquid surface. These stabilizers themselves... The solution surface is insufficient to form a tight adsorption film to achieve the effect of foam suppression; and the stabilizer itself can quickly spread and disperse on the surface of the system, dispersing its foam-suppressing substances in the system, which can significantly reduce the surface tension of the foam system liquid, so as to achieve the effect of rapid bubble breaking and inhibiting bubble generation. While ensuring the accuracy of blood cell analysis test results (including but not limited to PLT), it has a long-lasting (at least two years) foam suppression and defoaming effect, ensuring the long-term stability of the kit, greatly reducing the standing time required after the kit is transported, improving the accuracy and precision of the test, and benefiting end-customer operation and clinical sample testing.

[0034] In a specific embodiment, the preferred stabilizer includes at least one of polysorbate and polyoxypropylene ethylene glycerol ether. The addition of polysorbate and / or polyoxypropylene ethylene glycerol ether does not interact with other components in the diluent, or the interaction is negligible, does not alter the original physical, chemical, or biological properties of the system, and does not damage blood samples or affect blood cell detection results. Furthermore, the addition of polysorbate and / or polyoxypropylene ethylene glycerol ether allows for rapid replacement (i.e., displacing) of foaming agent molecules on the surface of micron-sized bubble films. These stabilizers themselves are insufficient to form a tight adsorption film on the solution surface, and they significantly reduce local surface tension, thereby rapidly breaking up bubbles and inhibiting bubble formation. They also exhibit excellent diffusion properties, remaining stably dispersed in the diluent for a long period, resulting in long-lasting (at least two years) antifoaming and defoaming effects. This ensures the long-term stability of the diluent, significantly reduces the settling time required after transport, improves detection accuracy and precision, and benefits end-user operation and clinical sample testing.

[0035] In a specific embodiment, the preferred stabilizer is a mixture of polysorbate and polyoxypropylene ethylene glycerol ether, which can be mixed in any proportion, preferably (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., and there is no specific limitation. By compounding polysorbate and polyoxypropylene ethylene glycerol ether, the defoaming effect on the diluent is better, the defoaming is faster, and the foam suppression effect on the diluent is better, resulting in better and longer-lasting stability of the diluent, which is beneficial to improving the accuracy and precision of detection. Furthermore, by compounding the two, a smaller amount of stabilizer is needed to achieve an effective amount, so that the total amount of stabilizer in the diluent is only 0.0001-0.04% by mass to achieve a good stabilizing, defoaming, and foam suppression effect for a longer period of time (at least 2.2 years).

[0036] In a specific embodiment, the preferred polysorbate is 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, and stabilizing effects, resulting in good system dispersion and promoting the dissolution of other substances, but without interacting with other components, or with very little effect, negligible. Secondly, the above polysorbate stabilizers do not adversely affect blood samples; and they can effectively reduce the surface tension of the liquid in the diluent, thereby achieving the effect of rapid bubble breakage and bubble inhibition, and also resulting in good system dispersion, thus providing a long-lasting (at least two years) antifoaming and defoaming effect.

[0037] In a specific embodiment, the preferred stabilizer is a mixture of Tween 20, Tween 80, and polyoxypropylene ethylene glycerol ether. The three can be mixed in any proportion, preferably 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. The specific ratio is not limited. The stabilizer is obtained by mixing Tween 20, Tween 80, and polyoxypropylene ethylene glycerol ether. The combination of oxypropylene oxide ethylene glycerol ether and other compounds results in a system with good dispersion and long-term dispersion. It also has a better and faster defoaming effect on the diluent and a better antifoaming effect, resulting in better and longer-lasting stability of the diluent. This is beneficial for improving the accuracy and precision of detection, and the cost is relatively low. Furthermore, by combining the three components, a smaller amount of stabilizer is needed to achieve an effective amount. The total amount of stabilizer in the diluent is only 0.0001% to 0.03% by mass to achieve good stabilization, defoaming, and antifoaming effects for a longer period of time (at least 2.5 years).

[0038] In a specific embodiment, the average molecular weight of the polyoxypropylene ethylene glycerol ether is preferably 1000-15000, and the CAS number of the polyoxypropylene ethylene glycerol ether is 9003-11-6. The polyoxypropylene ethylene glycerol ethers selected in this invention are all commercially available finished products, used directly without processing. The molecular weight of the polyoxypropylene ethylene glycerol ether will affect the defoaming and foam suppression effects of the diluent. If the molecular weight of the polyoxypropylene ethylene glycerol ether is too small, it will not achieve a good defoaming and foam suppression effect. If the molecular weight of the polyoxypropylene ethylene glycerol 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 also fail to achieve a good defoaming and foam suppression effect. In this invention, the average molecular weight of polyoxypropylene ethylene glycerol ether is preferably 1000-15000. The average molecular weight of polyoxypropylene ethylene glycerol ether can be 1000, 1500, 2000, 2500, 3000, 4000, 5000, 6000, 7000, 8000, 9000, 10000, 11000, 12000, 13000, 14000, 15000, etc., and there is no specific limitation. Selecting polyoxypropylene ethylene glycerol ether with the above average molecular weight can prevent the formation of a tight adsorption film on the solution surface, and the stabilizer itself can significantly reduce the local surface tension, so as to achieve the effect of rapid bubble breaking and bubble generation, resulting in a long-lasting (at least two years) antifoaming and defoaming effect, ensuring the long-term stability of the diluent, greatly reducing the standing time required after the diluent is transported, and improving the accuracy and precision of the detection.

[0039] In one specific embodiment, it is further preferred that the average molecular weight of the polyoxypropylene vinyl glycerol ether is between 2000 and 6000. The average molecular weight of the polyoxypropylene vinyl glycerol ether can be 2000, 2100, 2200, 2300, 2400, 2500, 2600, 2700, 2800, 2900, 3000, 3500, 4000, 4500, 5000, 5500, 6000, etc., and there is no specific limitation. By selecting polyoxypropylene vinyl glycerol ether with the above average molecular weight, a smaller amount (approximately 0.0% of the mass percentage of the diluent system) can be used. A concentration of 0.01% to 0.035% is sufficient to achieve stabilization, defoaming, and foam suppression effects on the diluent, and this effect can be maintained for a long time (at least 2.1 years). Using polyoxypropylene ethylene glycerol ether with the above average molecular weight ensures that a tight adsorption film is not formed on the solution surface, and the stabilizer itself can significantly reduce local surface tension, thereby rapidly breaking up bubbles and inhibiting bubble formation. This results in a long-lasting (at least 2.1 years) foam suppression and defoaming effect, guaranteeing the long-term stability of the diluent, greatly reducing the time required for settling after transportation, and improving the accuracy and precision of the detection.

[0040] In a specific embodiment, the preferred polyoxypropylene 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 4 ... 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) 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) The above polyoxypropylene ethylene glycerol ethers are commercially available products that can be used immediately after purchase without any processing. Choosing the above stabilizers ensures that a tight adsorption film is not formed on the surface of the diluted solution, and the stabilizers themselves can significantly reduce the local surface tension, thereby achieving the effect of rapid bubble breakage and bubble generation, resulting in long-lasting anti-foaming and defoaming effects, ensuring the long-term stability of the diluted solution, greatly reducing the standing time required after the diluted solution is transported, and improving 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% to 0.0045%. Examples include 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%, and 0. The specific amounts are 0.002%, 0.0025%, 0.003%, 0.0035%, 0.0037%, 0.0040%, 0.0045%, etc., without any specific limitation. It is understood that in this embodiment, the proportion of stabilizer in the diluent is very, very small. That is to say, adding such a small amount of stabilizer ensures that the stabilizer will not affect other components in the system, will not damage the blood sample, and will not affect the detection of blood cell items. Moreover, the addition of stabilizer within this range plays a good role in stabilizing the system, reducing the generation of micron-sized bubbles and achieving the effect of rapidly breaking up micron-sized bubbles.

[0042] In a specific embodiment, the preferred concentration of the buffer solution is 10–50 mM, the osmotic pressure regulator has a mass percentage of 0.5–0.9% in the diluent, the preservative has a mass percentage of 0.01–0.02% in the diluent, and the stabilizer has a mass percentage of 0.002–0.003% in the diluent. By using the above-ratio buffer solution, osmotic pressure regulator, preservative, and stabilizer, the present invention combines these components to form a diluent with excellent chemical and physical properties. The addition of the stabilizer enables the diluent to maintain long-term stability, at least 2.1 years, effectively reducing the impact of micron-sized bubbles on detection and improving detection accuracy and precision.

[0043] In a specific embodiment, the preferred buffer is one or more of the following: phosphate buffer, borate buffer, Tris buffer, citrate buffer, carbonate buffer, and GOOD'S series buffers. The addition of the above buffers can stabilize the pH of the diluent within the target range, which has a good effect on stabilizing the system and will not adversely affect the determination of blood cells in the sample to be tested. Selecting different buffers 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. Selecting the above osmotic pressure regulator can make the diluent an isotonic solution without damaging the blood sample, which is beneficial for subsequent dilution of the blood sample and improves the accuracy and precision of the test.

[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 failure of the diluent due to microbial contamination can be effectively prevented, which is beneficial to extending the shelf life of the diluent.

[0046] In some specific embodiments, the fillable volume of the diluent is no more than 100 mL, such as 1 mL, 2 mL, 3 mL, 4 mL, 5 mL, 10 mL, 15 mL, 20 mL, 25 mL, 30 mL, 35 mL, 40 mL, 45 mL, 50 mL, 55 mL, 60 mL, 65 mL, 70 mL, 75 mL, 80 mL, 85 mL, 90 mL, 95 mL, and 100 mL, etc., and there is no specific limitation. The technical solution of the present invention can ensure long-term antifoaming and defoaming effects even with small fill volumes of diluent, ensuring the long-term stability of the reagent kit and greatly reducing the standing time required after the reagent kit is transported. Especially for impedance method detection of blood cells, it can greatly improve the detection accuracy and precision, which is beneficial to end-user operation and clinical sample testing.

[0047] Furthermore, the preferred filling volume of the diluent is no more than 5 mL, meaning it can be 5 mL, 4.5 mL, 4 mL, 3.5 mL, 3 mL, etc., with no specific limitation. In routine blood cell testing, a diluent of 5 mL or less is sufficient for analysis. Limiting the filling volume to this range ensures sufficient testing volume, resulting in a smaller kit size and saving on usage. On the other hand, due to the influence of external forces and air mixing, small volumes of diluent are more prone to generating micron-sized bubbles during transportation or drops due to impacts and vibrations. In other words, the bubbles generated by small volumes of diluent during collisions are not the conventional bubbles visible to the naked eye; their size is similar to that of a PLT (partially 100 μL), invisible to the naked eye, difficult to eliminate, and affect the test results of blood cell tests. The technical solution of this invention can ensure long-term anti-foaming and defoaming effects with extremely small diluent volumes, ensuring the long-term stability of the kit, greatly reducing the settling time required after kit transportation, improving the accuracy and precision of the test, and benefiting end-user operation and clinical sample testing.

[0048] Example 1

[0049] A diluent for blood cell testing includes a buffer solution, an osmotic pressure regulator, a preservative, and a stabilizer, as shown in the table below.

[0050] Table 1. Formulation of the diluent in Example 1

[0051]

[0052]

[0053] Note: In this embodiment, Tris buffer can be replaced with at least one of phosphate buffer, borate buffer, citrate buffer, carbonate buffer, GOOD'S series buffers, or a mixture thereof; sodium chloride can be replaced with at least one of potassium chloride, sodium sulfate, or a mixture thereof; Tween 20 can be replaced with at least one of polysorbate and polyoxypropylene ethylene glycerol ether described above; sodium azide can be replaced with at least one of ProClin series, Kathon series, penicillin, gentamicin, or a mixture thereof; replacing the above substances does not affect the results of this embodiment.

[0054] Example 2

[0055] A diluent for blood cell testing includes a buffer solution, an osmotic pressure regulator, a preservative, and a stabilizer, as shown in the table below.

[0056] Table 2. Formulation of the diluent in Example 2

[0057]

[0058] Example 3

[0059] A diluent for blood cell testing includes a buffer solution, an osmotic pressure regulator, a preservative, and a stabilizer, as shown in the table below.

[0060] Table 3. Formulation of the diluent in Example 3

[0061]

[0062] Example 4

[0063] A diluent for blood cell testing includes a buffer solution, an osmotic pressure regulator, a preservative, and a stabilizer, as shown in the table below.

[0064] Table 4. Formulation of the diluent in Example 4

[0065]

[0066] Example 5

[0067] A diluent for blood cell testing includes a buffer solution, an osmotic pressure regulator, a preservative, and a stabilizer, as shown in the table below.

[0068] Table 5. Formulation of the diluent in Example 5

[0069]

[0070]

[0071] Comparative Example 1

[0072] The difference between Comparative Example 1 and Example 1 is that no stabilizer was added to the diluent; otherwise, they are the same as in Example 1.

[0073] Comparative Example 2

[0074] The difference between Comparative Example 2 and Example 1 is that the amount of stabilizer added to the diluent is 0.055% of the mass percentage of the diluent, while all other aspects are the same as in Example 1.

[0075] The samples were transported using diluents from Examples 1-5 and Comparative Examples 1-2, and tested after standing for 24 hours: blank, accuracy, repeatability, stability, and clinical relevance.

[0076] 1. Blank test and its results

[0077] After transporting and returning the diluted samples from Examples 1-5, the blank samples were tested 5 times. The test results should meet the requirements in the table below:

[0078] Table 6. Blank Count Requirements

[0079] project Blank counting requirements 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. Results of Blank Counts for Transport Returns in Example 1

[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. Results of Blank Counts for Transport Returns in Example 2

[0083]

[0084]

[0085] Table 9. Blank Count Results of Transport Returns in Example 3

[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. Results of Blank Counts for Transport Returns in Example 4

[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. Results of Blank Counts for Transport Returns in Example 5

[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: Blank Count Results of Transport Returns

[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] The test results in Tables 7-12 show that the blank count results of Examples 1-5 of the present invention after being transported and left to stand for 24 hours meet the requirements. However, the PLT result of Comparative Example 1 without added stabilizer after standing for 24 hours is very high and fails to meet the standard requirements, and cannot be used for clinical sample testing.

[0094] 2. Repeatability tests and their results

[0095] After being transported back using the diluents of Examples 1-5 and Comparative Examples 1-2, two fresh samples were tested 10 times each. The mean (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 13-25. The test results should meet the requirements in the following table:

[0096] Formula (1):

[0097] In the formula: —The average value of the test results; x i — The measured value for each test; n — the number of tests; i — the test number; B — the relative deviation; SD — the standard deviation; CV — 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

[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

[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

[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

[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

[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

[0117]

[0118]

[0119] Table 22. Repeatability Test Results of Example 5

[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

[0122]

[0123]

[0124] Table 24. Repeatability Test Results of Comparative Example 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. Repeatability Test Results of Comparative Example 2

[0127]

[0128]

[0129] The test results in Tables 13 to 25 show that the repeatability of the tests conducted after transportation of Examples 1 to 5 of the present invention meets the requirements. However, the background PLT results of Comparative Example 1 (without stabilizer) and Comparative Example 2 (with stabilizer added in amounts exceeding the scope of the present invention) are very high and fail to meet the standard requirements, and therefore cannot be used for clinical sample testing.

[0130] 3. Accuracy test and results

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

[0132] Formula (3):

[0133] In the formula:

[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. Accuracy Results of Comparative Example 1

[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. Accuracy Results of Comparative Example 2

[0151]

[0152] The test results in Tables 27 to 33 show that the repeatability of the tests conducted after transportation of Examples 1 to 5 of the present invention meets the requirements. However, the background PLT results of Comparative Example 1 (without added stabilizer) and Comparative Example 2 (with stabilizer dosage exceeding the range disclosed in the present invention) are very high and fail to meet the standard requirements, and therefore cannot be used for clinical sample testing.

[0153] 4. Clinical relevance tests and their results

[0154] A clinical sample (40 cases) covering the linear range was simultaneously tested using a reference diluent (a commercially available formulation from Mindray, batch number M-5D) and Example 1. Linear regression analysis was performed with the measured values ​​of the reference diluent on the x-axis and the measured values ​​of Example 1 on the y-axis. The test results are shown in Table 34 and Appendix. Figures 1-6 As shown. The test results should meet the following requirements: the slope k of the linear regression equation should be between 0.9 and 1.1, and the correlation coefficient R0 should be... 2 ≥0.95.

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

[0156]

[0157]

[0158] The test results in Table 34 show that, when linear regression analysis was performed on the clinical samples tested with the diluent of Example 1 and the reference diluent, the slope k and correlation R of the linear regression equation were analyzed. 2 All met the requirements, demonstrating that the diluent of Example 1 has a good correlation with commercially available diluents.

[0159] 5. Stability Test

[0160] The diluted solutions of Examples 1-5 were placed at 56°C for 19 days for accelerated heat treatment (equivalent to a two-year shelf life at room temperature), and then transported. After the samples were returned from transport, the background and accuracy were tested.

[0161] (1) Blank test

[0162] Table 35. Results of Accelerated Transport Blank Test in Example 1

[0163] Sample number 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. Results of Accelerated Transportation Blank Test in Example 2

[0165] Sample number 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. Results of Accelerated Transportation Blank Test in Example 3

[0167]

[0168]

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

[0170] Sample number 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. Results of Accelerated Transport Blank Test in Example 5

[0172] Sample number 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 number 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 number 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 number 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 number 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] As can be seen from Tables 35 to 44, after the diluents of Examples 1 to 5 of the present invention were placed at 56°C for 19 days for accelerated heating and after transportation, the precision and accuracy of the diluents of the present invention met the requirements. In other words, the diluents of the present invention can meet the usage requirements for at least two years.

[0186] The above data and accompanying drawings demonstrate that the performance tests conducted using the diluent of this invention all meet the acceptance criteria. The feasibility and rationality of this invention are verified through the specific embodiments described above. These embodiments are merely illustrative examples of optional embodiments of this invention and are not intended to limit the scope thereof. For those skilled in the art, any changes, modifications, and substitutions made within the scope of the claims of this patent application should be included within the scope of the claims of this patent and fall within the protection scope of this invention.

[0187] It is understood that the above embodiments only illustrate preferred embodiments of the present invention, and their descriptions are relatively specific and detailed, but they should not be construed as limiting the scope of the present invention. It should be noted that those skilled in the art can freely combine the above technical features without departing from the concept of the present invention, and can also make several modifications and improvements, all of which fall within the protection scope of the present invention. Therefore, all equivalent transformations and modifications made with respect to the scope of the claims of the present invention should fall within the scope of the claims of the present invention.

Claims

1. A diluent for blood cell detection, characterized in that, 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 has a mass percentage of 0.1–2% in the diluent solution. The preservative has a mass percentage of 0.01–0.05% in the diluent solution. The stabilizer is a mixture of Tween 20, Tween 80, and polyoxypropylene ethylene glycerol ether in a ratio of 1:(1–5):(1–5). The stabilizer has a mass percentage of 0.0001–0.05% in the diluent solution. The pH of the diluent solution is 7.4–7.

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 ethylene 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 ethylene glycerol ether in a ratio of (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 2, characterized in that, The average molecular weight of the polyoxypropylene ethylene glycerol ether is 1000 to 15000.

6. The diluent for blood cell detection according to claim 2, characterized in that, The polyoxypropylene 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 ... (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) The following are examples of 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 mixtures of the above substances.

7. The diluent for blood cell detection according to claim 1, characterized in that, The stabilizer is present in a mass percentage of 0.0001 to 0.0045% of the diluted solution.

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

9. The diluent for blood cell detection according to any one of claims 1-8, characterized in that, The buffer solution is one or more of phosphate buffer, borate buffer, Tris buffer, citrate buffer, carbonate buffer, and GOOD'S series buffers; the osmotic pressure regulator is one or more of sodium chloride, potassium chloride, sodium sulfate, and potassium sulfate; and the preservative is one or more of sodium azide, ProClin series, Kathon series, penicillin, and gentamicin.

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