Small-volume impedance method blood cell detection kit and bedside diagnosis blood cell analyzer

Abstract

The invention discloses a small-volume impedance method blood cell detection kit and a bedside diagnosis blood cell analyzer. The kit comprises a diluent accommodating part for accommodating a diluent and a stabilizer; wherein the filling amount of the diluent containing part is not larger than 100 mL, and the stabilizer comprises at least one of polysorbate and polyoxypropylene oxyethylene glyceryl ether; by adding the stabilizer into the diluent of the kit, the effects of quickly breaking bubbles and inhibiting generation of the bubbles can be achieved, so that the kit has long-acting foam inhibiting and defoaming effects, the long-term stability of the kit for at least two years is ensured, the standing time required for use after the kit is transported is greatly shortened, and the kit is safe and reliable. The detection accuracy and precision are improved, and terminal customer operation and clinical sample testing are facilitated.

Description

Technical Field

[0001] The present invention relates to the technical field of blood cell analysis, and in particular to a small-volume impedance blood cell detection kit and a bedside diagnosis blood cell analyzer. Background Art

[0002] At present, due to problems with existing filling technology, small-volume test kits cannot fill all containers containing diluents. In other words, there is a gap in the upper part of the filling container, leaving air, which is easily impacted, vibrated, etc. during transportation or falling. This will cause micron-level bubbles to be generated in the diluent in the test kit, and the micron-level bubbles are difficult to eliminate in a short period of time, especially tiny bubbles of 1 to 10 μm, which are difficult to defoam by standing for a short time; and the size of these micron-level bubbles is similar to PLT (platelets), resulting in the micron-level bubbles being identified as PLT during the detection process, causing PLT false positive phenomenon. Summary of the invention

[0003] The technical problem to be solved by the present invention is that, in view of the defects in the prior art, the present invention proposes a small-volume impedance blood cell detection kit and a bedside diagnostic blood cell analyzer.

[0004] The technical solution adopted by the present invention to solve the technical problem is: a small-volume impedance blood cell detection kit, the kit is used for bedside diagnosis of blood cell analysis, the kit comprises:

[0005] A diluent containing portion, used for containing the diluent and the stabilizer;

[0006] Wherein, the filling volume of the diluent containing portion is no more than 100 mL, and the stabilizer includes at least one of polysorbate and polyoxypropylene oxyethylene glycerol ether.

[0007] Furthermore, it is preferred that the diluent and the stabilizer are pre-installed in the diluent containing portion or are separately arranged in a diluent container of a preset capacity.

[0008] Furthermore, it is preferred that the loading volume of the diluent containing portion is no more than 5 mL.

[0009] Furthermore, it is preferred that the average molecular weight of the polyoxypropylene oxyethylene glycerol ether is 1000 to 15000.

[0010] 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.

[0011] Furthermore, it is preferred that the stabilizer is a mixture of polysorbate and polyoxypropylene oxyethylene glycerol ether, which are mixed in any ratio so that the mass percentage of the stabilizer in the diluent is 0.0001 to 0.05%.

[0012] 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.

[0013] Furthermore, it is preferred that the stabilizer is a mixture of Tween 20, Tween 80 and polyoxypropylene oxyethylene glycerol ether, which are mixed in any ratio so that the mass percentage of the stabilizer in the diluent is 0.0001 to 0.05%.

[0014] Furthermore, it is preferred that the stabilizer accounts for 0.0001 to 0.05% by mass of the diluent.

[0015] Furthermore, it is preferred that the diluent further comprises a buffer, an osmotic pressure regulator and a preservative.

[0016] Furthermore, preferably, the concentration of the buffer solution is 5 to 100 mM, the mass percentage of the osmotic pressure regulator is 0.1 to 2%, the mass percentage of the stabilizer in the diluent is 0.0001 to 0.05%, the mass percentage of the preservative is 0.01 to 0.5%, and the pH of the diluent is 7.4 to 7.8.

[0017] Furthermore, preferably, the concentration of the buffer solution is 10-90 mM, the mass percentage of the osmotic pressure regulator in the diluent is 1-2%, and the mass percentage of the preservative in the diluent is 0.01-0.2%.

[0018] 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; 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, Casone series, penicillin, and gentamicin.

[0019] The present invention also provides a bedside diagnostic blood cell analyzer, comprising:

[0020] Analyzer body;

[0021] A detection seat, arranged on the analyzer body, for accommodating a reagent kit;

[0022] The above-mentioned kit is assembled on the detection seat for sample analysis, and the PLT background parameter in the analysis result is less than 10×10 9 Pieces / L.

[0023] The invention has the following beneficial effects: the invention provides a small-volume impedance method blood cell detection kit, wherein at least one component selected from polysorbate and polyoxypropylene oxyethylene glycerol ether is added to the diluent in the kit as a stabilizer of the diluent of the invention; firstly, the addition of the stabilizer does not react with the original system in the diluent, and does not affect the detection result of the blood cells; secondly, during the transportation or falling process 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 themselves are not sufficient to form a tight adsorption film on the solution surface, so as to achieve the effect of suppressing bubbles; and the stabilizer itself can be quickly spread and dispersed on the system surface, and its foam suppressing substance is dispersed in the system, which can significantly reduce the surface tension of the bubble system liquid, so as to achieve the effect of quickly breaking the bubbles and suppressing the generation of bubbles. While ensuring the accuracy of blood cell analysis test results (including but not limited to PLT), it has a long-term (at least two years) anti-foaming and defoaming effect, 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.

[0024] The present invention applies a small-volume impedance blood cell detection kit to a bedside diagnostic blood cell analyzer, which can greatly shorten the time for the kit to stand and defoam before detection, improve the detection efficiency, and the PLT background parameter in the analysis result is less than 10×10 9 Pieces / L, which effectively improves the accuracy and precision of the test, and is beneficial to end-customer operations and clinical sample testing. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] 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.

[0026] Figure 1 is the WBC correlation test result of Example 1 of the present invention and the reference diluent;

[0027] Figure 2 is the PLT correlation test result of Example 1 of the present invention and the reference dilution;

[0028] Figure 3 is the RBC correlation test result of Example 1 of the present invention and the reference diluent;

[0029] Figure 4 HGB correlation test results of Example 1 of the present invention and the reference dilution;

[0030] Figure 5 HCT correlation test results of Example 1 of the present invention and the reference diluent;

[0031] Figure 6 MCV correlation test results of Example 1 of the present invention and the reference dilution;

[0032] Figure 7 A simplified structural diagram of a bedside diagnostic blood cell analyzer in an embodiment of the present invention. DETAILED DESCRIPTION

[0033] 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.

[0034] The present invention provides a small-volume impedance blood cell detection kit, which is used for bedside diagnosis of blood cell analysis, and the kit includes: a diluent containing part for containing a diluent and a stabilizer. Wherein, the filling volume of the diluent containing part 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 restrictions; during production and packaging, the stabilizer can be directly added to the diluent, directly filled in the diluent containing part of the kit, and used directly; the stabilizer includes at least one of polysorbate and polyoxypropylene oxyethylene glycerol ether.

[0035] The present invention adds at least one component of polysorbate and polyoxypropylene oxyethylene glycerol ether as a stabilizer for the diluent of the present invention. Firstly, the addition of the above stabilizers does not interact with the original system in the diluent, that is, whether it is the addition of polysorbate stabilizers, the addition of polyoxypropylene oxyethylene glycerol ether stabilizers, or the addition of the above mixtures, they will not interact with each other, or the effect that occurs is negligible, and will not cause changes in the physical, chemical or biological properties of the original system, and will not affect the detection results of blood cells; secondly, during the transportation or falling process of the diluent, the stabilizer added to the diluent can be adsorbed on the bubble liquid film surface of the micron-sized bubbles, and can quickly replace (i.e. squeeze) on the liquid surface. The stabilizers themselves are not sufficient to form a tight adsorption film on the surface of the solution to achieve the effect of suppressing foaming. The stabilizers themselves can quickly spread and disperse on the surface of the system, and disperse their 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 suppressing the generation of bubbles. In addition, the stabilizers have excellent diffusion performance and can be stably dispersed in the diluent for a long time, so that they have long-term (at least two years) anti-foaming and defoaming effects, especially for tiny bubbles of 1 to 10 μm. The long-term stability of the test kit is ensured, the time required for the test kit to be left to stand after transportation is greatly shortened, the accuracy and precision of the test are improved, and it is beneficial to the operation of end customers and clinical sample testing.

[0036] In some preferred embodiments, the filling amount of the diluent container is not more than 5mL, that is, the filling amount of the diluent is not more than 5mL, and can be 5mL, 4.5mL, 4mL, 3.5mL, 3mL, etc., without specific restrictions. In conventional blood cell detection, diluent within 5mL 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 reagent 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 is, the more likely it is to generate micron-level bubbles due to impact, vibration, etc. during transportation or falling. That is to say, 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. Their size is similar to that of PLT, invisible to the naked eye, difficult to eliminate, and affect 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, ensure the long-term stability of the reagent kit, greatly shorten the time required for the reagent kit to be left to stand after transportation, improve the accuracy and precision of the detection, and facilitate terminal customer operation and clinical sample testing.

[0037] In another embodiment, the diluent and stabilizer are pre-installed in the diluent accommodating portion or are separately arranged in a diluent container of a preset capacity. That is to say, in the test kit received by the user, the diluent accommodating portion may be pre-filled with diluent and stabilizer, which is convenient for the user to directly put the test kit into the analyzer for use, which is simple and efficient. Of course, in the test kit received by the user, the diluent accommodating portion may be empty. In this case, the user can pour the received mixture of diluent and stabilizer into the diluent accommodating portion before testing. Since the diluent accommodating portion of the test kit does not need to be sealed with a film, the cost of the test kit is further reduced. Furthermore, the capacity of a separate diluent container may be within a preset range. Due to the characteristics of the use scenarios of the timely detection product, the number of samples that need to be detected simultaneously is not large. In order to avoid affecting the reaction results by using a diluent that has been opened for a long time, a separate diluent container may have the same capacity as the diluent containing part, or a separate diluent container may be several times or dozens of times the capacity of the diluent containing part, such as 5-50 times. Furthermore, it may be 5 times, 10 times, 15 times, 20 times, 25 times, 30 times, 35 times, 40 times, 45 times or 50 times, etc.

[0038] In some preferred embodiments, 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 and are used directly without being treated. The molecular weight of polyoxypropylene oxyethylene glyceryl ether will affect the defoaming and antifoaming effects of the diluent. Preferably, the average molecular weight of polyoxypropylene oxyethylene glyceryl ether is 1000-15000. 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. The average molecular weight of 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 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 two years) anti-foaming and defoaming effect, ensures the long-term stability of the test kit, greatly shortens the time required for the test kit to be left standing after transportation, and improves the accuracy and precision of the test.

[0039] Further, it is preferred that the polyoxypropylene ethylene glycol 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 1400. The average molecular weight of the poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol) is 4400; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol) has an average molecular weight of 5800; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol) has an average molecular weight of 2000; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol) has an average molecular weight of 1100; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol) 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 use of the above polyoxypropylene oxyethylene glycerol ether can further prevent the formation of a tight adsorption film on the surface of the solution, and can significantly reduce the local surface tension, so as to achieve the effect of quickly breaking bubbles and inhibiting the generation of bubbles, so as to have a long-term (at least two years) anti-foaming and defoaming effect.

[0040] In a specific embodiment, the stabilizer is preferably a mixture of polysorbate and polyoxypropylene oxyethylene glycerol ether, and the two can be mixed in any ratio so that the mass percentage of the stabilizer in the diluent is 0.0001-0.05%; the ratio of the two is 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., without specific limitation, by mixing polysorbate and polyoxypropylene oxyethylene glycerol ether. Glycerol ether is compounded to achieve better defoaming effect on the diluent, faster defoaming, better anti-foaming effect on the diluent, better stability of the diluent and longer-lasting effect, which is beneficial to improving detection accuracy and precision; further, by compounding the two, less stabilizer input can be used to achieve 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 and anti-foaming effect and longer-lasting effect (at least 2.2 years).

[0041] 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 21, 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 interaction 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.

[0042] In a specific embodiment, the stabilizer is a mixture of Tween 20, Tween 80 and polyoxypropylene oxyethylene glycerol ether, and the three are mixed in any ratio so that the mass percentage of the stabilizer in the diluent is 0.0001-0.05%; in this embodiment, Tween 20, Tween 80 and polyoxypropylene oxyethylene glycerol ether are compounded to make the defoaming faster, the anti-foaming effect on the diluent is better, and the stability of the kit is better. Preferably, the ratio of the three is 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., and there is no specific limitation. By compounding Tween 20, Tween 80 and polyoxypropylene oxyethylene glycerol ether, the viscosity of the system is always constant and the dispersion effect is The effect is good, the dispersion is maintained for a long time, the defoaming effect on the diluent is better, the defoaming is faster, and the anti-foaming effect on the diluent is better, 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 can be used to reach the 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 it is longer (at least 2.5 years).

[0043] In a specific embodiment, the stabilizer is a mixture of polysorbate and polyoxypropylene oxyethylene glycerol ether, wherein the polysorbate is one of Tween 20, Tween 80, Tween 21, Tween 40, Tween 60, Tween 61, Tween 81 and Tween 85, and the average molecular weight of polyoxypropylene oxyethylene glycerol ether is two of 1000 to 15000, and the three are mixed in any ratio so that the mass percentage of the stabilizer in the diluent is 0.0001 to 0.05%; in this embodiment, polysorbate and polyoxypropylene oxyethylene glycerol ether are compounded to make the defoaming faster, the anti-foaming effect on the diluent is better, and the stability of the kit is better. Preferably, the ratio of the three is 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 specific limitation. By compounding polysorbate and polyoxypropylene oxyethylene glycerol ether, the viscosity of the system is constant and the dispersion effect is good. Maintaining long-term dispersion, the defoaming effect of the diluent is better, the defoaming is faster, and the anti-foaming effect of the diluent is better, so that the stability of the diluent is better and longer-lasting, which is beneficial to improving the accuracy and precision of detection, and the cost is low; further, through the compounding of the three, a smaller amount of stabilizer can be used to reach the effective amount, so that the total amount of stabilizer in the diluent is 0.0001-0.02% by mass to achieve better stabilization effect, defoaming and anti-foaming effect and longer duration (at least 2.3 years).

[0044] In a specific embodiment, the stabilizer is a single component of any one of polysorbate and polyoxypropylene oxyethylene glycerol ether. The addition of a single component makes the production easier to control and the operation simpler. In a specific embodiment, the stabilizer is 0.0001-0.05% by mass of the diluent, such as the stabilizer is 0.0001%, 0.0002%, 0.0003%, 0.0004%, 0.0005%, 0.0006%, 0.0007%, 0.0008%, 0.0009%, 0.001%, 0.002%, 0.003%, 0.004%, 0.005%, 0.006%, 0.007%, 0.008%, 0.009%, 0.01%, 0.015%, 0.02%, 0.03%, 0.04%, 0.05%, etc., of the mass percentage of the diluent. It is not limited to this. It can be seen that in the present invention, In the specification, the proportion of the input amount of the stabilizer in the diluent is extremely small, that is to say, the input amount of the stabilizer is controlled within this range so that it will not react with the original system and will not affect the original system of the diluent, or the influence on other components of the diluent is negligible, which will not affect the detection of blood cell items, and can well play the role of stabilizing the diluent, reduce the generation of micron-level bubbles, and achieve the effect of quickly breaking micron-level bubbles; 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 also fail to achieve a good anti-foaming and defoaming effect.

[0045] In a specific embodiment, the weight percentage of the stabilizer is preferably 0.0001-0.01% of the diluent. 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%, 0.002%, 0.0025%, 0.003%, 0.0035%, 0.0037 %, 0.0040%, 0.0045%, 0.005%, 0.006%, 0.007%, 0.008%, 0.009% and 0.01%, 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 impossible for the stabilizer to react with other components in the system, nor to damage the blood sample, nor to affect the detection of blood cell items; and the addition of a stabilizer within this range can play a role in stabilizing the system better, can reduce the generation of micron-level bubbles and can achieve the effect of quickly breaking the micron-level bubbles, and can remain effective for a long time, and can remain stable and effective for at least 2.5 years.

[0046] In a specific embodiment, the diluent also includes a buffer, an osmotic pressure regulator and a preservative. The addition of the buffer can stabilize the pH of the diluent within the target range; the addition of the osmotic pressure regulator can adjust the osmotic pressure of the system to make the diluent an isotonic solution; the addition of the preservative prevents the kit from becoming ineffective due to microbial contamination, which is beneficial to extending the storage period of the diluent.

[0047] In a specific embodiment, the concentration of the buffer solution is 5 to 100 mM. The concentration of the buffer solution may be 5 mM, 10 mM, 15 mM, 20 mM, 25 mM, 30 mM, 35 mM, 40 mM, 45 mM, 50 mM, 55 mM, 60 mM, 65 mM, 70 mM, 75 mM, 80 mM, 85 mM, 90 mM, 95 mM and 100 mM, 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 within this concentration range will not adversely affect 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. The mass percentage of the preservative is 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., without specific limitation. Controlling the amount of the preservative within this range can effectively prevent the failure of the test kit due to microbial contamination, which is beneficial to prolonging the storage period of the diluent. The stabilizer is 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. The stabilizer within this range can effectively stabilize the diluent system, reduce and inhibit the generation of micron-level bubbles; control The mass percentage of the osmotic pressure regulator is 0.1-2%, such as the mass percentage of the osmotic pressure regulator in the system 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 an isotonic solution to prevent affecting the detection of blood cells; by using the buffer, osmotic pressure regulator, stabilizer and preservative in the above range, the above components are compounded to form a diluent having excellent chemical and physical properties, can maintain long-term stability, effectively reduce the influence of micron-level bubbles on detection, and improve detection accuracy and precision.

[0048] Furthermore, the preferred concentration of the buffer solution is 10-90 mM, the mass percentage of the osmotic pressure regulator is 1-2%, and the mass percentage of the preservative is 0.01-0.2%. By using the buffer solution, osmotic pressure regulator, stabilizer and preservative within the above range, the above components are compounded to form a diluent having excellent chemical and physical properties, can maintain long-term stability, effectively reduce the impact of micron-level bubbles on detection, and improve detection accuracy and precision.

[0049] Furthermore, the preferred buffer is one or more of phosphate buffer, borate buffer, Tris buffer, citrate buffer, carbonate buffer, and GOOD'S series buffer. There is no specific limitation. Different buffer systems are selected according to different test items. The above buffer systems can stabilize the system pH well and do not affect blood cell detection; the osmotic pressure regulator is one or more of sodium chloride, potassium chloride, sodium sulfate, and potassium sulfate. The use of the above osmotic pressure regulators can well achieve the effect of regulating osmotic pressure; the preservative is one or more of sodium azide, ProClin series, Kasone series, penicillin, and gentamicin. By selecting the above preservatives, microbial contamination can be well prevented, which is beneficial to prolonging the storage validity period of the diluent.

[0050] In some embodiments, the kit of the present invention also includes a hemolytic agent accommodating portion for accommodating a hemolytic agent, wherein the hemolytic agent includes an osmotic pressure regulator, a buffer solution, a surfactant and a preservative, the mass percentage of the osmotic pressure regulator in the hemolytic agent is 0.1-2%, and the concentration of the buffer solution is 5-100 mM. By using the buffer solution, osmotic pressure regulator, surfactant and preservative in the above range, the above components are compounded to form a hemolytic agent having excellent chemical and physical properties, can maintain long-term stability, and improve detection accuracy and precision.

[0051] The mass percentage of the preservative in the hemolytic agent is 0.05-0.5%, and the mass percentage of the surfactant is 0.1-5%; for example, the mass percentage of the osmotic pressure regulator in the hemolytic agent is 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 1.1%, 1.2%, 1.3%, 1.4%, 1.5%, 1.6%, 1.7%, 1.8%, 1.9% and 2.0%, etc., without specific limitation. Controlling the osmotic pressure regulator within this range can make the hemolytic agent an isotonic solution to prevent affecting the detection of blood cells. The mass percentage of the preservative is controlled to be 0.05-0.5%, such as 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., without specific limitation. Controlling the amount of the preservative within this range can effectively prevent the hemolytic agent from failing due to microbial contamination, which is beneficial to prolonging the storage period of the hemolytic agent.

[0052] The concentration of the buffer solution of the hemolytic agent can be 5 to 100 mM, such as 5 mM, 10 mM, 15 mM, 20 mM, 25 mM, 30 mM, 35 mM, 40 mM, 45 mM, 50 mM, 55 mM, 60 mM, 65 mM, 70 mM, 75 mM, 80 mM, 85 mM, 90 mM, 95 mM and 100 mM, etc., without specific limitation. Controlling the pH of the hemolytic agent within this range can effectively control the pH stability of the hemolytic agent within the target range, that is, the pH is 4.2 ± 0.2, and the buffer solution within this concentration range will not adversely affect 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.

[0053] Among them, the surfactant in the hemolytic agent can be at least one of octaalkyltrimethylammonium chloride, decanyltrimethylammonium chloride, dodecyltrimethylammonium chloride, hexadecyltrimethylammonium chloride, dodecyltrimethylammonium bromide, hexadecyltrimethylammonium bromide, Triton X-100, Tween-20, nonylphenol polyoxyethylene ether, dodecyl polyoxyethylene ether, polyethylene glycol octylphenyl ether, polyoxyethylene nonylphenyl ether, Tween-80, polyoxyethylene lauryl ether, polyether L-35 and polyether F-6. The addition of the surfactant can significantly reduce the surface tension of the hemolytic agent system and is conducive to the dispersion of each component.

[0054] The kit of the present invention is easy to use, low in cost, high in accuracy and precision, and good in stability. It can be used in conjunction with a fully automatic blood cell analyzer, and can be used immediately after the user receives the kit or after it has been left to stand for a short time, without the need for long-term standing, thereby facilitating user operation and clinical testing.

[0055] The present invention also provides a bedside diagnostic blood cell analyzer, such as Figure 7 As shown, it includes an analyzer body 10; a detection seat 11, which is arranged on the analyzer body 10 and is used to accommodate a reagent kit 12; a reagent kit 12, which is assembled on the detection seat 11 for sample analysis; and the PLT background parameter in the analysis result is less than 10. It can be understood that the application of the above-mentioned reagent kit in a bedside diagnostic blood cell analyzer can make the PLT background parameter less than 10, effectively improving the accuracy and precision of the detection, and can also greatly shorten the time for the reagent kit to stand and defoam before detection, thereby improving the detection efficiency, which is beneficial to terminal customer operation and clinical sample testing.

[0056] In addition, the test kit may include: a detection area and / or a reagent area and / or a consumable area, etc. The detection area is used to detect the sample and reagent system in order to output the test results; the reagent area may include the diluent solute area, the hemolytic agent solute area, etc.; the consumable area may include a TIP placement area, etc. In a specific embodiment, the positional relationship between the above-mentioned areas, the type and quantity of each area can be determined according to the detection requirements, and are not specifically limited here. Furthermore, the detection area and / or reagent area and / or consumable area and other areas can be integrally formed into a module, or can be arranged as a detachable link. Of course, they can also be arranged as independent modules without a connection relationship. In order to achieve the purpose of facilitating detection and reducing costs, the above are all optional settings and are not specifically limited here.

[0057] During use (taking the case where the diluent container is pre-filled with diluent and stabilizer as an example), the user places the received test kit on the detection seat after leaving it to stand or directly places it to start the detection of the corresponding item.

[0058] Before the test begins, the instrument and reagents need to be tested, including: the TIP absorbs the diluent (i.e., the mixture of the diluent and the stabilizer in this application, the same below) and transfers it to the detection pool in the detection area, and detects it by impedance method and outputs the background test results. Since the diluent contains a stabilizer, it can eliminate and / or inhibit the generation of bubbles in the reagent kit during the process of falling, collision, etc., and the PLT background parameter can reach less than 10×10 9 The requirement of pieces / L is met to ensure the accuracy of sample test results.

[0059] During the sample detection process, the TIP absorbs the sample, diluent or a mixture of hemolytic agent and diluent and transfers it to the detection pool in the detection area, performs detection by impedance method and outputs the test results. Specifically, when hemoglobin needs to be detected, a mixture of sample, hemolytic agent and diluent is absorbed; when hemoglobin does not need to be detected, a mixture of sample and diluent is absorbed.

[0060] The present invention is explained below by means of specific examples.

[0061] Example 1

[0062] A small-volume impedance blood cell detection kit is used for bedside diagnosis of blood cell analysis. The kit includes: a diluent containing part for containing a diluent and a stabilizer. The specific formula of the contents in the diluent containing part is shown in the table below.

[0063] Table 1. Formulation of the kit of Example 1

[0064]

[0065] 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.

[0066] Example 2

[0067] A small-volume impedance blood cell detection kit is used for bedside diagnosis of blood cell analysis, and has a diluent containing part for containing diluent and stabilizer. The specific formula of the contents in the diluent containing part is shown in the table below.

[0068] Table 2. Formulation of the kit of Example 2

[0069]

[0070] Example 3

[0071] A small-volume impedance blood cell detection kit is used for bedside diagnosis of blood cell analysis, and has a diluent containing part for containing diluent and stabilizer. The specific formula of the contents in the diluent containing part is shown in the table below.

[0072] Table 3. Formulation of the kit of Example 3

[0073]

[0074]

[0075] Example 4

[0076] A small-volume impedance blood cell detection kit is used for bedside diagnosis of blood cell analysis, and has a diluent containing part for containing diluent and stabilizer. The specific formula of the contents in the diluent containing part is shown in the table below.

[0077] Table 4. Formulation of the kit of Example 4

[0078]

[0079] Example 5

[0080] A small-volume impedance blood cell detection kit is used for bedside diagnosis of blood cell analysis, and has a diluent containing part for containing diluent and stabilizer. The specific formula of the contents in the diluent containing part is shown in the table below.

[0081] Table 5. Formulation of the kit of Example 5

[0082]

[0083] Comparative Example 1

[0084] 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.

[0085] Comparative Example 2

[0086] 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.

[0087] The blood cell assay kits 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 test.

[0088] 1. Blank test and its results

[0089] After the kits 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:

[0090] Table 6. Blank count requirements

[0091] 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％

[0092] Table 7. Example 1 Transport return blank count results

[0093] 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

[0094] Table 8. Example 2 Transport return blank count results

[0095] Serial number WBC RBC HGB HCT PLT 1 0 0 0 0 1 2 0 0 0 0 1 3 0 0 0 0 0 4 0 0 0 0 3 5 0 0 0 0 4

[0096] Table 9. Example 3 Transport return blank count results

[0097] 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

[0098] Table 10. Example 4 Transport return blank count results

[0099] 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

[0100] Table 11. Example 5 Transport return blank count results

[0101] 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

[0102] Table 12. Comparative Example 1 Transport Return Blank Count Results

[0103] 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

[0104] 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.

[0105] 2. Repeatability test and its results

[0106] After the kits 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 results are shown in Tables 13 to 25. The test results should meet the requirements of the following table:

[0107]

[0108] 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.

[0109] Table 13. Repeatability test requirements

[0110]

[0111] Table 14. Repeatability test results of Example 1

[0112] Serial number WBC RBC HGB PLT HCT MCV 1 8.92 4.7 138 278 38.2 81.2 2 8.61 4.74 135 274 38.4 81 3 8.66 4.81 135 285 39 81.1 4 9 4.79 137 284 38.9 81.2 5 8.72 4.78 136 284 38.8 81.1 6 8.69 4.78 136 278 38.8 81.3 7 8.61 4.75 136 279 38.6 81.3 8 8.61 4.75 135 282 38.6 81.4 9 8.62 4.74 135 279 38.5 81.3 10 8.67 4.65 133 282 37.9 81.5 Mean 8.711 4.749 135.6 280.5 38.57 81.24 SD 0.137796 0.046774 1.349897 3.472111 0.336815 0.150555 CV 1.58％ 0.98％ 1.00％ 1.24％ 0.87％ 0.19％

[0113] Table 15. Repeatability test results of Example 1 2

[0114]

[0115]

[0116] Table 16. Repeatability test results of Example 2 1

[0117] Serial number WBC RBC HGB PLT HCT MCV 1 8.92 4.5 133 289 35.3 78.4 2 8.51 4.53 133 297 35.5 78.5 3 8.84 4.47 134 297 35 78.4 4 8.99 4.61 135 292 36.3 78.7 5 8.72 4.58 136 291 36 78.6 6 8.83 4.55 133 284 35.8 78.7 7 8.76 4.52 134 286 35.6 78.7 8 8.66 4.59 134 286 36.1 78.7 9 8.86 4.56 134 292 36 78.9 10 8.88 4.6 134 290 36.4 79.2 Mean 8.797 4.551 134 290.4 35.8 78.68 SD 0.1393 0.0458 0.9428 4.4020 0.4472 0.2394 CV 1.58％ 1.01％ 0.70％ 1.52％ 1.25％ 0.30％

[0118] Table 17. Repeatability test results of Example 2

[0119]

[0120]

[0121] Table 18. Repeatability test results of Example 3 1

[0122] 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％

[0123] Table 19. Repeatability test results of Example 3 2

[0124]

[0125]

[0126] Table 20. Repeatability test results of Example 4 1

[0127] 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％

[0128] Table 21. Repeatability test results of Example 4 2

[0129]

[0130]

[0131] Table 22. Repeatability test results of Example 5 1

[0132] 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％

[0133] Table 23. Repeatability test results of Example 5 2

[0134] Serial number WBC RBC HGB PLT HCT MCV 1 4.83 5.03 155 259 40.5 80.4 2 4.82 5.03 154 263 40.6 80.6 3 4.81 5.05 153 275 40.6 80.5 4 4.77 5.04 154 260 40.5 80.4 5 4.81 4.98 154 264 40 80.4 6 4.75 5.01 155 269 40.3 80.5 7 4.94 4.98 153 259 40.1 80.5 8 4.68 4.97 154 260 40.1 80.5 9 4.66 4.99 153 273 40.1 80.5 10 4.73 4.95 154 251 39.9 80.6 Mean 4.78 5.003 153.9 263.3 40.27 80.49 SD 0.081 0.034 0.738 7.258 0.263 0.074 CV 1.70％ 0.67％ 0.48％ 2.76％ 0.65％ 0.09％

[0135] Table 24. Comparative Example 1 Repeatability Test Results 1

[0136] 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％

[0137] Table 25. Comparative Example 2 Repeatability Test Results 2

[0138] Serial number WBC RBC HGB PLT HCT MCV 1 9.63 5.18 136 701 35.5 83.9 2 6.8 5.61 167 612 31.8 98.5 3 7.04 5.56 120 915 43.7 81.4 4 8.75 4.09 130 401 42.8 87.6 5 6.73 5.59 144 883 33.7 84.8 6 9.19 4.15 125 448 42.8 79.9 7 7.34 4.68 168 834 46.3 78.8 8 7.1 4.88 134 412 43.7 81.9 9 8.34 4.91 163 924 44.8 76.8 10 8.79 3.87 150 440 38.8 95.4 Mean 9.63 5.18 136 701 35.5 83.9 SD 6.8 5.61 167 612 31.8 98.5 CV 7.04 5.56 120 915 43.7 81.4

[0139] From the test results of Tables 13 to 25, it can be found that the repeatability of Examples 1 to 5 of the present invention was tested after transportation and 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.

[0140] 3. Accuracy test and its results

[0141] 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 results are shown in Tables 26 to 33. The test results should meet the requirements of the following table:

[0142] Formula (3):

[0143] Where:

[0144] T——sample reference machine result;

[0145] B——Relative deviation.

[0146] Table 26. Accuracy requirements

[0147]

[0148] Table 27. Accuracy results of Example 1

[0149] 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％

[0150] Table 28. Accuracy results of Example 2

[0151]

[0152]

[0153] Table 29. Accuracy results of Example 3

[0154] 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％

[0155] Table 30. Accuracy results of Example 4

[0156] 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％

[0157] Table 31. Accuracy results of Example 5

[0158] 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％

[0159] Table 32. Comparative Example 1 Accuracy Results

[0160] 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％

[0161] Table 33. Comparative Example 2 Accuracy Results

[0162]

[0163] 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.

[0164] 4. Clinically relevant tests and their results

[0165] 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.

[0166] Table 34. Clinical relevance test results of Example 1

[0167]

[0168]

[0169] From Table 34, Figure 1 to Figure 6 The test results show that the results of the clinical sample test of the diluent of Example 1 and the reference diluent 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.

[0170] 5. Stability test

[0171] The dilutions of Examples 1 to 5 were placed in a 56° C. thermal acceleration chamber 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.

[0172] (1) Blank test

[0173] Table 35. Example 1 accelerated transport blank test results

[0174] 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

[0175] Table 36. Example 2 accelerated transport blank test results

[0176] 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

[0177] Table 37. Example 3 Accelerated Transport Blank Test Results

[0178] Sample No. WBC RBC HGB HCT PLT 1 0 0 0 0 2 2 0 0 0 0 1 3 0 0 0 0 1 4 0 0 0 0 5 5 0 0 0 0 1

[0179] Table 38. Example 4 Accelerated Transport Blank Test Results

[0180] 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

[0181] Table 39. Example 5 accelerated transport blank test results

[0182]

[0183]

[0184] (2) Accuracy test

[0185] Table 40. Accuracy test results of Example 1

[0186] 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％

[0187] Table 41. Accuracy test results of Example 2

[0188] Sample No. WBC RBC HGB HCT MCV PLT 3 5.76 5.61 163 51.9 92.6 238 2 5.68 5.48 163 50.1 91.4 251 1 5.95 5.7 162 52.8 92.7 234 Mean 5.80 5.60 162.67 51.60 92.23 241.00 Target value 5.58 5.51 160 49.6 93.3 228 Relative deviation 3.88％ 1.57％ 1.67％ 4.03％ -1.14％ 5.70％

[0189] Table 42. Accuracy test results of Example 3

[0190] 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％

[0191] Table 43. Accuracy test results of Example 4

[0192] 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％

[0193] Table 44. Accuracy test results of Example 5

[0194] 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％

[0195] 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.

[0196] 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.

[0197] 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 small-volume impedance blood cell detection kit, characterized in that: The kit is used for bedside diagnosis of blood cell analysis, and the kit comprises: A diluent containing portion, used for containing the diluent and the stabilizer; Wherein, the filling volume of the diluent containing portion is no more than 100 mL, and the stabilizer includes at least one of polysorbate and polyoxypropylene oxyethylene glycerol ether.

2. The small-volume impedance blood cell detection kit according to claim 1, characterized in that: The diluent and stabilizer are pre-installed in the diluent containing portion or are separately arranged in a diluent container of a preset capacity.

3. The small-volume impedance blood cell detection kit according to claim 1, characterized in that: The diluent container can be filled with no more than 5 mL.

4. The small-volume impedance blood cell detection kit according to any one of claims 1 to 3, characterized in that: The stabilizer accounts for 0.0001-0.05% of the mass percentage of the diluent.

5. The small-volume impedance blood cell detection kit according to claim 4, characterized in that: The stabilizer accounts for 0.0001-0.01% by mass of the diluent.

6. The small-volume impedance blood cell detection kit according to claim 5, characterized in that: The stabilizer is a mixture of polysorbate and polyoxypropylene oxyethylene glycerol ether.

7. The small-volume impedance blood cell detection kit according to claim 1, 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.

8. The small-volume impedance blood cell detection kit according to claim 7, characterized in that: The stabilizer is a mixture of Tween 20, Tween 80 and polyoxypropylene oxyethylene glycerol ether.

9. The small-volume impedance blood cell detection kit according to claim 1, characterized in that: The average molecular weight of the polyoxypropylene oxyethylene glycerol ether is 1000-15000.

10. The small-volume impedance blood cell detection kit according to claim 9, 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.

11. The small-volume impedance blood cell detection kit according to claim 1, characterized in that: The diluent also includes a buffer, an osmotic pressure regulator and a preservative.

12. The small-volume impedance blood cell detection kit according to claim 11, characterized in that: 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 stabilizer in the diluent is 0.0001 to 0.05%, the mass percentage of the preservative in the diluent is 0.01 to 0.5%, and the pH of the diluent is 7.4 to 7.

8.

13. A bedside diagnostic blood cell analyzer, characterized in that: include: Analyzer body; A detection seat, arranged on the analyzer body, for accommodating a reagent kit; The kit according to any one of claims 1 to 12, which is mounted on the detection seat for sample analysis, and the PLT background parameter in the analysis result is less than 10×10 9 Pieces / L.

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