Small-volume impedance method-based blood cell detection kit, and bedside diagnostic blood cell analyzer

Abstract

A small-volume impedance method-based blood cell detection kit, and a bedside diagnostic blood cell analyzer. The kit comprises a diluent accommodating portion for accommodating a diluent and a stabilizer. The diluent accommodating portion has a fillable volume of no more than 100 mL, and the stabilizer comprises at least one of a polysorbate and polyoxypropylene oxyethylene glycol ether. The addition of the stabilizer into the diluent in the kit can achieve the effect of quickly breaking bubbles and inhibiting the generation of bubbles, so that the kit has a long-lasting foaming suppression and defoaming effect, the long-term stability of the kit is ensured for at least two years, the time the kit needs to be left to stand after transportation for use is greatly shortened, and the accuracy and precision of the detection is improved, which is beneficial to terminal customer operation and clinical sample testing.

Description

Small-volume impedance blood cell detection kit and bedside diagnostic blood cell analyzer Technical Field

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

[0002] At present, due to problems with existing filling technology, small-volume test kits cannot completely fill the containers containing diluents. In other words, there is a gap in the upper part of the filling container, leaving air, which is easily impacted and vibrated during transportation or dropping. 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 at the 1~10μm level, which are difficult to defoam by standing still 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 positives. 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-based 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, which is used for bedside diagnosis of blood cell analysis, and the kit includes:

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

[0006] The diluent container can be filled with no more than 100 mL of liquid, and the stabilizer includes at least one of polysorbate and polyoxypropylene oxyethylene glycerol ether.

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

[0008] Furthermore, it is preferred that the diluent container has a filling volume of no more than 5 mL.

[0009] Furthermore, it is preferred that the average molecular weight of the polyoxypropylene oxyethylene glycerol ether is 1,000 to 15,000.

[0010] Furthermore, the polyoxypropylene ethylene glycol ether is preferably poly(propylene glycol)-block-poly(ethylene glycol)-block-poly(propylene glycol), with an average molecular weight of 2000; or, poly(propylene glycol)-block-poly(ethylene glycol)-block-poly(propylene glycol), with an average molecular weight of 2700; or, poly(propylene glycol)-block-poly(ethylene glycol)-block-poly(propylene glycol), with an average molecular weight of 3300; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), with an average molecular weight of 4400; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), 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.

[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 glycol 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, the kit preferably further comprises a diluent and a stabilizer, wherein 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, it is preferred that 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 to 90 mM, the mass percentage of the osmotic pressure regulator in the diluent is 1 to 2%, and the mass percentage of the preservative in the diluent is 0.01 to 0.2%.

[0018] Furthermore, the buffer includes Tris buffer, the concentration of the Tris buffer is 50 mM; the osmotic pressure regulator includes sodium chloride, the mass percentage of the sodium chloride in the diluent is 1%; the stabilizer includes poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), the mass percentage of the poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol) in the diluent is 0.001%; ​​the preservative includes sodium azide, the mass percentage of the sodium azide in the diluent is 0.1%; and the pH of the diluent is 7.6.

[0019] Furthermore, the buffer includes a borate buffer, the concentration of the borate buffer is 90 mM; the osmotic pressure regulator includes potassium chloride, the mass percentage of the potassium chloride in the diluent is 0.2%; the stabilizer includes Tween 20 and poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), with an average molecular weight of 5800, and the mass percentage of Tween 20 and poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol) in the diluent is 0.0001%; ​​the preservative includes sodium azide, the mass percentage of sodium azide in the diluent is 0.02%; and the pH of the diluent is 7.4.

[0020] Furthermore, the buffer includes a borate buffer, the concentration of the borate buffer is 10 mM; the osmotic pressure regulator includes potassium chloride, the mass percentage of the potassium chloride in the diluent is 2%; the stabilizer includes Tween 20, Tween 80 and poly (ethylene glycol) -block -poly (propylene glycol) -block -poly (ethylene glycol), with an average molecular weight of 2000, the mass percentage of Tween 20, Tween 80 and poly (ethylene glycol) -block -poly (propylene glycol) -block -poly (ethylene glycol) in the diluent is 0.05%, the preservative includes sodium azide, the mass percentage of sodium azide in the diluent is 0.5%, and the pH of the diluent is 7.8.

[0021] Furthermore, the buffer includes Tris buffer, the concentration of the Tris buffer is 50 mM; the osmotic pressure regulator includes sodium chloride, the mass percentage of the sodium chloride in the diluent is 1%; the stabilizer includes Tween 20 and Tween 80, the mass percentage of the Tween 20 and Tween 80 in the diluent is 0.001%, the preservative includes sodium azide, the mass percentage of the sodium azide in the diluent is 0.1%, and the pH of the diluent is 7.6.

[0022] 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.

[0023] The present invention also provides a bedside diagnostic blood cell analyzer, comprising:

[0024] Analyzer body;

[0025] A loading seat, provided on the analyzer body, for accommodating a reagent kit;

[0026] The above-mentioned reagent kit is assembled on the loading base for sample analysis, and the PLT background parameter in the analysis result is less than 10×10 9 Pieces / L.

[0027] The present invention has the following beneficial effects: the present invention provides a small-volume impedance-based 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 for the diluent of the present invention. Firstly, the addition of the stabilizer does not interact with the existing system in the diluent and does not affect the blood cell detection results. Secondly, during the transportation or dropping of the diluent, the stabilizer added to the diluent is adsorbed on the bubble liquid film surface of micron-sized bubbles and can replace (i.e., squeeze out) the foaming agent molecules on the liquid surface. The stabilizer itself is insufficient to form a tight adsorption film on the solution surface, thereby achieving a foam suppression effect. Furthermore, the stabilizer itself can quickly spread and disperse on the surface of the system, dispersing its foam suppression substances in the system, thereby significantly reducing the surface tension of the bubble system liquid, thereby achieving the effect of quickly breaking bubbles and suppressing bubble generation. 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.

[0028] The present invention applies a small-volume impedance-based 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 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 detection, and is beneficial to end-customer operations and clinical sample testing. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] 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.

[0030] FIG1 is a WBC correlation test result of Example 1 of the present invention and a reference diluent;

[0031] FIG2 is a PLT correlation test result of Example 1 of the present invention and a reference dilution;

[0032] FIG3 is a RBC correlation test result of Example 1 of the present invention and a reference diluent;

[0033] FIG4 is a result of a HGB correlation test between Example 1 of the present invention and a reference dilution;

[0034] FIG5 is a test result of HCT correlation between Example 1 of the present invention and a reference dilution;

[0035] FIG6 is a test result of the MCV correlation between Example 1 of the present invention and a reference dilution;

[0036] FIG7 is a simplified structural diagram of a bedside diagnostic blood cell analyzer according to an embodiment of the present invention. DETAILED DESCRIPTION

[0037] 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 with reference to examples. The examples are only used to explain the present invention and do not constitute a limitation on the scope of protection of the present invention.

[0038] The present invention provides a small-volume impedance-based blood cell detection kit, which is used for bedside diagnosis of blood cell analysis. The kit includes: a diluent container for accommodating a diluent and a stabilizer. The diluent container can be filled with 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., without specific restrictions. During production and packaging, the stabilizer can be directly added to the diluent and directly filled into the diluent container of the kit for direct use. The stabilizer includes at least one of polysorbate and polyoxypropylene oxyethylene glycerol ether.

[0039] The present invention adds at least one of polysorbate and polyoxypropylene oxyethylene glycerol ether as a stabilizer to the diluent. First, the addition of the above stabilizers does not interact with the original system in the diluent. That is, whether the addition of polysorbate stabilizers, polyoxypropylene oxyethylene glycerol ether stabilizers, or the addition of the above mixtures will not interact with the other, or the interaction 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 test results of blood cells. Second, during the transportation or dropping of the diluent, the stabilizer added to the diluent can be adsorbed on the bubble liquid film surface of micron-sized bubbles and can be quickly replaced on the liquid surface (i.e., squeezed out). (walk) foaming agent molecules; these stabilizers themselves are not sufficient to form a tight adsorption film on the surface of the solution to achieve the effect of suppressing foaming; and the stabilizer itself can quickly spread and disperse on the surface of the system, dispersing its anti-foaming substances in the system, which can significantly reduce the surface tension of the bubble system liquid, so as to achieve the effect of quickly breaking bubbles and suppressing bubble generation, and has excellent diffusion performance and can be stably dispersed in the diluent for a long time, so that it has a long-term (at least two years) anti-foaming and defoaming effect, especially for tiny bubbles at the 1~10μm level. It is better, 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 operation and clinical sample testing.

[0040] In some preferred embodiments, the diluent container can be filled with no more than 5 mL. That is, the filling volume of the diluent is no more than 5 mL, and can be 5 mL, 4.5 mL, 4 mL, 3.5 mL, 3 mL, etc., without specific limitation. In conventional blood cell testing, less than 5 mL of diluent is sufficient for detection and analysis. Limiting the filling volume to this range can ensure sufficient detection volume and make the reagent kit smaller, thereby saving dosage. On the other hand, due to the influence of external forces and the degree of air mixing, small amounts of diluent are more likely to generate micron-level bubbles due to impact, vibration, etc. during transportation or dropping. That is, the bubbles more likely to be generated during the collision of small amounts 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 blood cell items. The technical solution of the present invention can ensure long-term anti-foaming and defoaming effects even with extremely small diluent filling volumes, thereby ensuring the long-term stability of the reagent kit, greatly shortening the time required for the reagent kit to be left standing after transportation, improving the accuracy and precision of the test, and facilitating end-user operation and clinical sample testing.

[0041] In another embodiment, the diluent and stabilizer are pre-installed in the diluent holding portion or separately provided in a diluent container of a preset capacity. That is to say, in the test kit received by the user, the diluent holding portion may be pre-filled with the diluent and stabilizer, which makes it convenient for the user to directly place 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 holding portion may be empty. In this case, the user can pour the received mixture of diluent and stabilizer into the diluent holding portion before testing. Since the diluent holding 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 scenario of the timely detection product, the number of samples that need to be tested simultaneously is not large. In order to avoid affecting the reaction results by using a diluent that has been opened for a long time, the separate diluent container may have the same capacity as the diluent containing part, or the separate diluent container may have 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.

[0042] In some preferred embodiments, the CAS number of the polyoxypropylene oxyethylene glycerol ether is 9003-11-6. The polyoxypropylene oxyethylene glycerol ethers selected in the present invention are all commercially available finished products that are used directly without being treated. The molecular weight of the polyoxypropylene oxyethylene glycerol ether will affect the defoaming and antifoaming effects of the diluent. Preferably, the average molecular weight of the polyoxypropylene oxyethylene glycerol ether is 1000 to 15000. If the molecular weight of the polyoxypropylene oxyethylene glycerol ether is too small, it will not achieve a good antifoaming and defoaming effect. If the molecular weight of the polyoxypropylene oxyethylene 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 antifoaming and defoaming effect. The average molecular weight of the polyoxypropylene oxyethylene glycerol ether can be 1000, 1500, 2000, 2500, 3000, 4000, 5000, 6000, 7000, 8000, 9000, 10000, 11000, 12000, 13000, 14000, 15000, etc., without specific limitation. The use of polyoxypropylene oxyethylene glycerol ether with the above average molecular weight can prevent the formation of 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, thereby having 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 stand still after transportation, and improving the accuracy and precision of the test.

[0043] Furthermore, the polyoxypropylene glycol ether is preferably poly(propylene glycol)-block-poly(ethylene glycol)-block-poly(propylene glycol) with an average molecular weight of 2000; or, poly(propylene glycol)-block-poly(ethylene glycol)-block-poly(propylene glycol) with an average molecular weight of 2700; or, poly(propylene glycol)-block-poly(ethylene glycol)-block-poly(propylene glycol) with an average molecular weight of 3300; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol) with an average molecular weight of 4400; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol) with an average molecular weight of 5800; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol) , with an average molecular weight of 2000; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), with an average molecular weight of 1100; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), with an average molecular weight of 14600; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol) , with an average molecular weight of 1900; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), with an average molecular weight of 2900; or, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), with an average molecular weight of 2800; poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), with an average molecular weight of 12600; poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), with an average molecular weight of 8400; or a mixture of the above substances; the use of the above polyoxypropylene oxyethylene glycerol ether can further make it insufficient to form 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-lasting (at least two years) anti-foaming and defoaming effect.

[0044] In a specific embodiment, the stabilizer is preferably a mixture of polysorbate and polyoxypropylene glycol 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%; preferably, the ratio of the two is (1-3): (1-5), such as 1:5, 1:4, 1:3, 1:2, 2:3, 1:1, 3:5, 3:2, 2:1, 3:1, etc., without specific limitation. By compounding polysorbate and polyoxypropylene glycol ether, the defoaming effect on the diluent is better, the defoaming is faster, the foam suppression effect on the diluent is better, and the stability of the diluent is better and longer-lasting, which is conducive to improving the accuracy and precision of the detection; further, by compounding the two, a smaller amount of stabilizer can be used to achieve an effective amount, so that the total amount of stabilizer is 0.0001-0.04% by mass in the diluent to achieve good stabilization effect, defoaming effect, and foam suppression effect, and longer-lasting (at least 2.2 years).

[0045] 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). These polysorbate stabilizers have diffusion, solubilization, and stabilization properties, resulting in a good dispersion effect in the system and promoting the dissolution of other substances, while not interacting with other components, or having a negligible interaction. Furthermore, these polysorbate stabilizers do not adversely affect the blood sample and can effectively reduce the surface tension of the liquid in the diluent, thereby rapidly breaking bubbles and inhibiting their generation. Furthermore, these stabilizers provide a good dispersion effect in the system and have a long-lasting (at least two years) anti-foaming and defoaming effect.

[0046] In a specific embodiment, the stabilizer is a mixture of Tween 20, Tween 80 and polyoxypropylene glycol ether, 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, Tween 20, Tween 80 and polyoxypropylene glycol ether are compounded to make defoaming faster, the anti-foaming effect on the diluent is better, and the stability of the kit is better. The preferred 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 maintained and the dispersion effect is improved. 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 accuracy and precision of the 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 0.0001-0.03% by mass to achieve better stabilization effect, defoaming and anti-foaming effect and longer-lasting (at least 2.5 years).

[0047] 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 defoaming faster, better anti-foaming effect on the diluent, and better stability of the kit. The preferred 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 consistent and the dispersion effect is good. Maintaining long-term dispersion has a better defoaming effect on the diluent, and 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 accuracy and precision of detection, and the cost is low; furthermore, 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-lasting (at least 2.3 years).

[0048] In a specific embodiment, the stabilizer is any one of polysorbate and polyoxypropylene oxyethylene glycerol ether. The addition of a single component makes it easier to control and simpler to operate during production. In a specific embodiment, the stabilizer is 0.0001 to 0.05% by mass 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%, 0.002%, 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% by mass of the diluent, etc., without specific limitation. It can be seen that in the present invention It is clear that 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 effect on other components of the diluent is negligible, which neither affects the detection of blood cell items nor can it effectively stabilize 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.

[0049] In a specific embodiment, the kit further comprises a diluent and a stabilizer; preferably, the mass percentage of the stabilizer is 0.0001 to 0.01% of the diluent, such as 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., without specific limitation; it can be understood that in the present embodiment, the proportion of the stabilizer in the diluent is very, very small, that is, the addition of such a small amount of stabilizer makes it possible for the stabilizer to not 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 better stabilizing the system, can reduce the generation of micron-sized bubbles and can achieve the effect of quickly breaking the micron-sized bubbles, and can maintain long-term effectiveness, and can remain stable and effective for at least 2.5 years.

[0050] In a specific embodiment, the diluent further 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, making the diluent an isotonic solution; the addition of the preservative prevents the test kit from becoming ineffective due to microbial contamination, which is beneficial to extending the storage validity period of the diluent.

[0051] 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 concentration 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 tested. 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., and is not specifically limited. Controlling the amount of the preservative within this range can effectively prevent the test kit from failing due to microbial contamination, which is beneficial to extending the storage period of the diluent. The stabilizer is 0.0001 to 0.05% by mass 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., and is not specifically limited. The stabilizer within this range can effectively stabilize the diluent system, reduce and inhibit the generation of micron-sized 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., and there is no 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 with 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.

[0052] 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.

[0053] 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 conducive to extending the storage validity period of the diluent.

[0054] In some embodiments, the kit of the present invention further includes a hemolytic agent holding portion for holding a hemolytic agent, wherein the hemolytic agent includes an osmotic pressure regulator, a buffer, 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 is 5-100 mM. By using the buffer, osmotic pressure regulator, surfactant, and preservative within 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.

[0055] 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., and there is no specific limitation. Controlling the amount of the preservative within this range can effectively prevent the hemolytic agent from being ineffective due to microbial contamination, which is beneficial to extending the storage validity period of the hemolytic agent.

[0056] 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 of the hemolytic agent to be stable 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 tested. Controlling the concentration of the buffer solution within this range can improve the accuracy and precision of the detection.

[0057] 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, polyoxyethylene nonylphenol ether, polyoxyethylene dodecyl ether, polyethylene glycol octylphenyl ether, polyoxyethylene nonylphenyl ether, Tween-80, polyoxyethylene lauryl ether, polyether L-35, and polyether F-6. The addition of a surfactant can significantly reduce the surface tension of the hemolytic agent system, facilitating the dispersion of the components.

[0058] 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 hematology analyzer, and can be used immediately after receiving the kit or after a short period of rest. It does not require long-term rest, and is convenient for user operation and clinical testing.

[0059] The present invention also provides a bedside diagnostic blood cell analyzer, as shown in FIG7 , comprising an analyzer body 10; a loading seat 11, which is arranged on the analyzer body 10 and is used to accommodate a reagent kit 12; and a reagent kit 12, which is assembled on the loading seat 11 for sample analysis. The loading seat 11 can be integrated with a detection module to detect the sample in the reagent kit 12 located on the loading seat 11. Of course, the detection module can also be set at other locations in the analyzer, as long as it can detect the sample in the reagent kit 12. In other words, the loading seat 11 is the location for detecting the sample, and there is no restriction on whether the detection module is integrated on the loading seat. Furthermore, arranging the detection module on the loading seat 11 can make the detection module correspond better to the reagent kit 12, thereby improving the reliability of the detection results; and the PLT background parameter in the analysis result is less than 10 (×10 9 / L), it is understandable that the above-mentioned kit can be used in bedside diagnostic blood cell analyzers to reduce the PLT background parameter to less than 10 (×10 9 / L), effectively improving the accuracy and precision of the test, and can also greatly shorten the time for the test kit to stand and defoam before testing, improving the test efficiency, which is beneficial to end-customer operations and clinical sample testing.

[0060] In addition, the test kit may include: a detection area and / or a reagent area and / or a consumables 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 consumables area may include a TIP placement area, etc. In a specific embodiment, the positional relationship of the above-mentioned various 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 consumables area and other areas can be integrally formed into a module, or can be set as a detachable link. Of course, they can also be set as independent modules with no connection relationship. In order to achieve the purpose of convenient detection, reducing costs, etc., the above are all optional settings and are not specifically limited here.

[0061] 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 loading base after it is left to stand or directly placed on the loading base to start the test of the corresponding item.

[0062] Before the test begins, the instrument and reagents need to be checked. Specifically, the TIP absorbs the diluent (i.e., a mixture of diluent and stabilizer in this application, the same below) and transfers it to the detection pool in the detection area. The impedance method is used to detect and output the background test results. Because the diluent contains a stabilizer, it can eliminate and / or suppress bubbles generated by the test kit during drops, collisions, 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.

[0063] During the sample testing process, the TIP draws a sample, a diluent, or a mixture of a hemolytic agent and a diluent, and transfers it to the detection cell in the testing area. It then performs impedance testing and outputs the test results. Specifically, when testing for hemoglobin, a mixture of the sample, a hemolytic agent, and a diluent is drawn; when testing for hemoglobin, a mixture of the sample and a diluent is drawn.

[0064] The present invention is explained below by means of specific examples.

[0065] Example 1

[0066] A small-volume impedance-based blood cell detection kit is used for bedside diagnosis of blood cell analysis. The kit includes: a diluent container for containing a diluent and a stabilizer. The specific formula of the contents in the diluent container is shown in the table below.

[0067] Table 1. Formulation of the kit of Example 1

[0068]

[0069] Note: In this example, Tris buffer can be replaced with at least one of phosphate buffer, borate buffer, citrate buffer, carbonate buffer, and GOOD'S series buffer, or a mixture thereof with Tris buffer; sodium chloride can be replaced with at least one of potassium chloride, sodium sulfate, and potassium sulfate, or a mixture thereof with sodium chloride; poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol) can be replaced with at least one of the polysorbates described above in the present invention, such as Tween 20, Tween 80, and other polyoxypropylene glycol ethers; sodium azide can be replaced with at least one of ProClin series, Kasson series, penicillin, and gentamicin, or a mixture thereof with sodium azide; replacement of the above substances does not affect the results of this example.

[0070] Example 2

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

[0072] Table 2. Formulation of the kit of Example 2

[0073]

[0074] Example 3

[0075] A small-volume impedance-based blood cell detection kit is used for bedside diagnosis of blood cell analysis. The kit includes a diluent container for containing a diluent and a stabilizer. The specific formula of the contents in the diluent container is shown in the table below.

[0076] Table 3. Formulation of the kit of Example 3

[0077]

[0078] Example 4

[0079] A small-volume impedance-based blood cell detection kit is used for bedside diagnosis of blood cell analysis. The kit includes a diluent container for containing a diluent and a stabilizer. The specific formula of the contents in the diluent container is shown in the table below.

[0080] Table 4. Formulation of the kit of Example 4

[0081]

[0082] Example 5

[0083] A small-volume impedance-based blood cell detection kit is used for bedside diagnosis of blood cell analysis. The kit includes a diluent container for containing a diluent and a stabilizer. The specific formula of the contents in the diluent container is shown in the table below.

[0084] Table 5. Formulation of the kit of Example 5

[0085]

[0086] Comparative Example 1

[0087] The difference between Comparative Example 1 and Example 1 is that no stabilizer is added to the diluent, and the other conditions are the same as those of Example 1.

[0088] Comparative Example 2

[0089] The difference between Comparative Example 2 and Example 1 is that the amount of stabilizer added to the diluent is 0.055% by mass of the diluent, and the rest is the same as Example 1.

[0090] 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 tests.

[0091] 1. Blank test and its results

[0092] After the kits of Examples 1 to 5 are returned, blank samples are measured 5 times. The test results should meet the requirements of the following table:

[0093]

[0094]

[0095]

[0096] From the test results in Tables 7 to 12, it can be found 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 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.

[0097] 2. Repeatability test and its results

[0098] After the kits of Examples 1 to 5 and Comparative Examples 1 to 2 were returned for transport, 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 results are shown in Tables 13 to 25. The test results should meet the requirements of the following table:

[0099] Formula (1): , formula (2): , formula (4): ;

[0100] Where: — the average value of the test results; ——The measured value each time; n——The number of tests; i——The test number; B——Relative deviation; SD——Standard deviation; CV is the coefficient of variation.

[0101]

[0102]

[0103]

[0104]

[0105]

[0106]

[0107]

[0108]

[0109] From the test results in Tables 13 to 25, it can be found that Examples 1 to 5 of the present invention were tested after transportation, and the repeatability performance met the requirements, while the background test PLT results of Comparative Example 1 in which no stabilizer was added and Comparative Example 2 in which the added amount exceeded 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.

[0110] 3. Accuracy test and its results

[0111] Fresh samples were measured using Examples 1 to 5 and Comparative Examples 1 and 2, respectively. The test was repeated three times, and 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:

[0112] Formula (3): ;

[0113] Where:

[0114] T——sample reference machine result;

[0115] B——Relative deviation.

[0116]

[0117]

[0118]

[0119] From the test results in 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.

[0120] 4. Clinical relevance tests and their results

[0121] A set of clinical samples (40 cases) covering the linear range were tested simultaneously using the reference diluent (a commercially available preparation purchased from Mindray, batch number M-5D) and Example 1. The measured values ​​of the reference diluent were plotted on the x-axis and the measured values ​​of Example 1 on the y-axis for linear regression analysis. The test results are shown in Table 34 and Figures 1 to 6. The test results should meet the requirements: the slope k of the linear regression equation should be between 0.9 and 1.1 and the correlation coefficient R should be between 0.9 and 1.1. 2 ≥0.95.

[0122] Table 34. Clinical relevance test results of Example 1

[0123]

[0124] From the test results in Table 34 and Figures 1 to 6, it was found that the results of the clinical sample test with the diluent of Example 1 and the reference diluent were subjected to linear regression analysis. The slope k and correlation R of the linear regression equation were 2 All of them meet the requirements, which proves that the diluent in Example 1 has a good correlation with the commercially available diluent.

[0125] 5. Stability test

[0126] The dilutions of Examples 1 to 5 were placed in a heat accelerated environment at 56°C for 19 days (equivalent to a two-year shelf life at room temperature), and then transported for testing. After returning from transport, the background and accuracy were tested.

[0127] (1) Blank test

[0128]

[0129]

[0130] (2) Accuracy test

[0131]

[0132]

[0133] As can be seen from Tables 35 to 44, the diluents of Examples 1 to 5 of the present invention, after being placed at 56° C. for 19 days and transported, have met the requirements for precision and accuracy. In other words, the diluents of the present invention can meet the use requirements for at least two years of validity.

[0134] 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 examples. The examples are only individual examples that can be selected for the present invention, but are not limited thereto. 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.

[0135] It is understandable that the above embodiments only express the preferred implementation modes of the present invention, and the description thereof is relatively specific and detailed, but it cannot be understood as limiting the patent scope of the present invention. It should be pointed out that for ordinary technicians in this field, without departing from the concept of the present invention, the above technical features can be freely combined, and several deformations and improvements can be made, all of which fall within the scope of protection of the present invention. Therefore, all equivalent changes and modifications made to the scope of the claims of the present invention should fall within the scope of 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 amount of the diluent containing part is not 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 contain no more than 5 mL of diluent.

4. The small-volume impedance blood cell detection kit according to any one of claims 1 to 3, characterized in that: The kit also includes a diluent and a stabilizer, wherein the stabilizer accounts for 0.0001 to 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 to 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 21, 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 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)-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. The small-volume impedance blood cell detection kit according to claim 12, characterized in that: The buffer includes Tris buffer, and the concentration of the Tris buffer is 50 mM; the osmotic pressure regulator includes sodium chloride, and the mass percentage of the sodium chloride in the diluent is 1%; the stabilizer includes poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), and the mass percentage of the poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol) in the diluent is 0.001%; ​​the preservative includes sodium azide, and the mass percentage of the sodium azide in the diluent is 0.1%; the pH of the diluent is 7.

6.

14. The small-volume impedance blood cell detection kit according to claim 12, characterized in that: The buffer comprises a borate buffer having a concentration of 90 mM; the osmotic pressure regulator comprises potassium chloride having a mass percentage of 0.2% in the diluent; the stabilizer comprises Tween 20 and poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol) having an average molecular weight of 5800, and the mass percentage of Tween 20 and poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol) in the diluent is 0.0001%; ​​the preservative comprises sodium azide having a mass percentage of 0.02% in the diluent; and the pH of the diluent is 7.

4.

15. The small-volume impedance blood cell detection kit according to claim 12, characterized in that: The buffer comprises a borate buffer having a concentration of 10 mM; the osmotic pressure regulator comprises potassium chloride having a mass percentage of 2% in the diluent; the stabilizer comprises Tween 20, Tween 80 and poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol) having an average molecular weight of 2000, and the mass percentage of Tween 20, Tween 80 and poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol) in the diluent is 0.05%; the preservative comprises sodium azide having a mass percentage of 0.5% in the diluent, and the pH of the diluent is 7.

8.

16. The small-volume impedance blood cell detection kit according to claim 12, characterized in that: The buffer includes Tris buffer, and the concentration of the Tris buffer is 50mM; the osmotic pressure regulator includes sodium chloride, and the mass percentage of the sodium chloride in the diluent is 1%; the stabilizer includes Tween 20 and Tween 80, and the mass percentage of the Tween 20 and Tween 80 in the diluent is 0.001%; ​​the preservative includes sodium azide, and the mass percentage of the sodium azide in the diluent is 0.1%, and the pH of the diluent is 7.

6.

17. The small-volume impedance blood cell detection kit according to claim 11, characterized in that: The buffer comprises at least one of phosphate buffer, borate buffer, Tris buffer, citrate buffer, carbonate buffer and GOOD'S series buffer.

18. The small-volume impedance blood cell detection kit according to claim 11, characterized in that: The osmotic pressure regulator includes at least one of sodium chloride, potassium chloride, sodium sulfate and potassium sulfate.

19. The small-volume impedance blood cell detection kit according to claim 11, characterized in that: The preservative includes at least one of sodium azide, ProClin series, Kasone series, penicillin, and gentamicin.

20. A bedside diagnostic blood cell analyzer, characterized in that: include: Analyzer body; A loading seat, arranged on the analyzer body, for accommodating a reagent kit; The kit according to any one of claims 1 to 19, which is mounted on the loading 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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