POCT blood cell kit, material selection method and POCT blood cell analyzer

Abstract

The invention discloses a POCT (point-of-care testing) blood cell kit, a material selection method thereof and a POCT blood cell analyzer. The POCT blood cell kit is characterized by plastic particles of the POCT blood cell kit according to a white blood cell blank counting result, a red blood cell blank counting result or a blood platelet blank counting result; moreover, when the number of precipitated particles represented by a white blood cell blank count result is not greater than 0.5 * 10 < 9 > / L, the number of precipitated particles represented by a red blood cell blank count result is not greater than 0.05 * 10 < 12 > / L, and the number of precipitated particles represented by a blood platelet blank count result is not greater than 10 * 10 < 9 > / L, the number of precipitated particles is not greater than 0.05 * 10 < 12 > / L; the plastic particles separated out of the POCT blood cell kit have low influence on the detection result, the blood cell detection result is high in accuracy, and the reliability of a POCT blood cell analyzer is improved.

Description

Technical Field

[0001] This application relates to the technical field of sample detection, and particularly to a POCT blood cell kit, a material selection method thereof, and a POCT blood cell analyzer. Background Art

[0002] A POCT blood cell kit is a box for containing chemical reagents for detecting chemical components, drug residues, virus types, etc. In the field of POCT blood cell analysis, the POCT blood cell kit can be used to carry reagents and samples to be tested, and serve as a reaction site and a detection site for the reagents and the samples to be tested, so as to realize the instant inspection of the samples, reduce the processes of reagent preparation and optimization by experimental personnel, and improve the sample detection efficiency.

[0003] In order to meet the requirement of light transmittance, the existing POCT blood cell kits usually use materials such as glass as the box body material, resulting in high production costs. In order to reduce the production costs, when the applicant uses plastic materials to prepare POCT blood cell kits, it is found that the property of easy precipitation of plastic particles will cause plastic particles to exist in the reagents sealed in the POCT blood cell kits, resulting in a reduction in the accuracy of the detection results when the POCT blood cell analyzer detects the POCT blood cell kits. Summary of the Invention

[0004] To solve the above technical problems, this application provides a POCT blood cell kit, a material selection method thereof, and a POCT blood cell analyzer.

[0005] To solve the above problems, this application provides a first technical solution: providing a POCT blood cell kit, including a box body, an impedance detection pool, and a reagent pool. The impedance detection pool is arranged in the box body; the reagent pool is arranged on one side of the box body away from the detection pool, and the reagent pool is used for storing reagents; within the service life of the POCT blood cell kit and under the recommended storage environment, when the reagents in the reagent pool are transferred to the impedance detection pool for particle counting of the kit precipitation, the number of precipitated particles characterized by the white blood cell blank counting result is not greater than 0.5×10 9 / L, the number of precipitated particles characterized by the red blood cell blank counting result is not greater than 0.05×10 12 / L, and the number of precipitated particles characterized by the platelet blank counting result is not greater than 10×10 9 / L.

[0006] Optionally, the reagent pool includes a diluent pool for storing diluent. When the diluent is transferred to the impedance detection pool for counting the precipitated particles in the reagent kit, the number of precipitated particles is characterized by the red blood cell blank count result and / or the platelet blank count result; or, the reagent pool includes a diluent pool and a hemolytic agent pool. The diluent pool is used to store diluent, and the hemolytic agent pool is used to store hemolytic agent. When the diluent and the hemolytic agent are transferred to the impedance detection pool for counting the precipitated particles in the reagent kit, the number of precipitated particles is characterized by the white blood cell blank count result.

[0007] Optionally, the impedance detection pool is used to perform a red blood cell blank count on the precipitated particles in the reagent kit, and the diameter range of the precipitated particles in the reagent kit is 6 - 9.5 μm; or, the impedance detection pool is used to perform a white blood cell blank count on the precipitated particles in the reagent kit, and the diameter range of the precipitated particles in the reagent kit is 2 - 20 μm; or, the impedance detection pool is used to perform a platelet blank count on the precipitated particles in the reagent kit, and the diameter range of the precipitated particles in the reagent kit is 2 - 4 μm.

[0008] Optionally, the reagent pool is encapsulated with a reagent of a preset liquid volume. After being stored for a preset time period, the liquid volume of the reagent in the reagent pool is the first liquid volume, and the difference between the preset liquid volume and the first liquid volume is not greater than 5% of the preset liquid volume.

[0009] Optionally, the reagents are encapsulated using the materials in the material list to obtain multiple test kits, and the test kits are stored for a preset time period, including: encapsulating a reagent of a preset liquid volume using the materials in the material list; performing a volatilization amount test on the reagent in the stored test kits to obtain the volatilization amount test results of the reagents in the multiple test kits, including: detecting the liquid volume of the reagent in the stored test kits to obtain the current liquid volume of the reagent; taking the difference between the preset liquid volume and the current liquid volume as the volatilization amount test result of the reagent.

[0010] Optionally, the impedance detection pool is used to transmit the detection light beam so that the detection light beam performs optical detection on the detection sample, and the light transmittance of the impedance detection pool is greater than or equal to 80%.

[0011] Optionally, the reagent pool is used to store the diluent and / or the hemolytic agent for a preset time period; wherein, the pH value range of the diluent is 7.4 - 7.8, the conductivity range of the diluent is 1550 - 1650 mS / m, the osmotic pressure range of the diluent is 300 - 320 mOsm / Kg, and the pH value range of the hemolytic agent is 4.0 - 4.4.

[0012] Optionally, the material of the box body includes homopolypropylene or block copolymer polypropylene.

[0013] To solve the above problems, the present application provides a second technical solution: providing a material selection method for a POCT blood cell kit, which is applied to the POCT blood cell kit as described above. The material selection method includes: encapsulating reagents with a variety of materials to obtain multiple test kits, and storing the test kits for a preset period of time; counting the precipitated particles of the reagents in the stored test kits to obtain the number of precipitated particles of the reagents in multiple test kits, and the number of precipitated particles is characterized by at least one of the red blood cell blank count result, the white blood cell blank count result, and the platelet blank count result; using the material with the number of precipitated particles not greater than the second preset threshold as the box body material of the POCT blood cell kit.

[0014] Optionally, after the step of encapsulating reagents with a variety of materials to obtain multiple test kits and storing the test kits for a preset period of time, the material selection method further includes: analyzing the physical and chemical properties of the reagents in the stored test kits to obtain the characteristic analysis results of the reagents in multiple test kits; or, testing the evaporation amount of the reagents in the stored test kits to obtain the evaporation amount test results of the reagents in multiple test kits.

[0015] To solve the above problems, the present application provides a third technical solution: providing a POCT blood cell analyzer, which includes a detection seat and a detection component. The detection seat is used to receive the POCT blood cell kit as described above; the detection component is arranged on the detection seat and is used to perform a complete blood count test on the test sample or reagent of the POCT blood cell kit; wherein, the kit includes a reagent pool and an impedance detection pool. During the service life of the POCT blood cell kit and under the recommended storage environment, the reagent in the reagent pool is transferred to the impedance detection pool, and the detection component is used to count the precipitated particles of the reagent and the blank sample in the impedance detection pool to obtain the number of precipitated particles of the POCT blood cell kit.

[0016] Different from the prior art, the plastic particles of the POCT blood cell kit of the present application are characterized by the white blood cell blank count result, the red blood cell blank count result, or the platelet blank count result; and, the number of precipitated particles characterized by the white blood cell blank count result is not greater than 0.5×10 9 / L, the number of precipitated particles characterized by the red blood cell blank count result is not greater than 0.05×10 12 / L, and when the number of precipitated particles characterized by the platelet blank count result is not greater than 10×10 9 / L, the influence of the precipitated plastic particles in the POCT blood cell kit of this embodiment on the test result is relatively low, the accuracy of the blood cell test result is high, and the reliability of the POCT blood cell analyzer is improved. Description of the Drawings

[0017] To more clearly illustrate the technical solutions in the embodiments of the present application, the following will briefly introduce the accompanying drawings required for the description of the embodiments. Obviously, the accompanying drawings in the following description are only some embodiments of the present application. For those of ordinary skill in the art, without creative efforts, other accompanying drawings can also be obtained based on these drawings. Among them:

[0018] Figure 1 is a schematic flowchart of the first embodiment of the material selection method provided by the present application;

[0019] Figure 2 is a schematic flowchart of the second embodiment of the material selection method provided by the present application;

[0020] Figure 3 is a schematic flowchart of the third embodiment of the material selection method provided by the present application. Detailed implementation manners

[0021] The following will clearly and completely describe the technical solutions in the embodiments of the present application in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only some embodiments of the present application, rather than all embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative efforts belong to the scope of protection of the present application.

[0022] It should be noted that if there are directional indications (such as up, down, left, right, front, back...) involved in the embodiments of the present application, the directional indications are only used to explain the relative positional relationship and movement conditions between components in a specific posture (as shown in the accompanying drawings). If the specific posture changes, the directional indications will also change accordingly.

[0023] In addition, if there are descriptions involving "first", "second", etc. in the embodiments of the present application, the descriptions of "first", "second", etc. are only for descriptive purposes and cannot be understood as indicating or implying their relative importance or implicitly indicating the quantity of the indicated technical features. Thus, the features defined with "first" and "second" may explicitly or implicitly include at least one of such features. In addition, the technical solutions between various embodiments can be combined with each other, but it must be based on the fact that those of ordinary skill in the art can implement it. When the combination of technical solutions is contradictory or cannot be implemented, it should be considered that such a combination of technical solutions does not exist and is not within the scope of protection required by the present application.

[0024] The embodiments of the present application first provide a POCT blood cell kit, which is applied to a POCT blood cell analyzer. The POCT blood cell analyzer is used to receive the kit and detect the test sample in the kit, so as to analyze the main inspection items involved in blood routine, such as red blood cells, white blood cells and platelets.

[0025] The detection data obtained when the POCT blood cell analyzer performs detection through the kit may include the detection data of the white blood cell line, such as white blood cell count (WBC), granulocyte number, granulocyte percentage, mid number, mid percentage, lymphocyte number, lymphocyte percentage, etc.; the detection data may also include the detection data of the red blood cell line, such as red blood cell count (RBC), hemoglobin concentration (HGB), hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin content (MCH), mean corpuscular hemoglobin concentration (MCHC), red blood cell distribution width coefficient of variation (RDW-CV), red blood cell distribution width standard deviation (RDW-SD), etc.; the detection data may further include the detection data of the platelet line, such as platelet count (PLT), mean platelet volume (MPV), platelet distribution width (PDW), large platelet number (P-LCR), large platelet ratio (P-LCC), platelet hematocrit (PCT), etc.

[0026] Please refer to Figure 1 , Figure 1 which is a schematic structural diagram of an embodiment of the POCT blood cell kit provided by the present application. As Figure 1 shown, the POCT blood cell kit of this embodiment includes a box body 11, an impedance detection cell 12 and a reagent cell 13. The impedance detection cell 12 is arranged in the box body 11; the reagent cell 13 is arranged on one side of the box body 11 away from the detection cell, and the reagent cell 13 is used to store reagents.

[0027] Specifically, a plurality of holes or slots are provided on the box body 11 of the POCT blood cell test kit to set an impedance detection pool 12 and a reagent pool 13 on the test kit. The impedance detection pool 12 is used as a place for impedance detection. Impedance detection includes but is not limited to red blood cell count, white blood cell count, platelet count and other test items tested using electrical impedance method. The reagent pool 13 is used to store the reagents required for the test so that the POCT blood cell analyzer can prepare samples using the reagents on the POCT blood cell test kit. The POCT blood cell analyzer does not need a built-in reagent storage device to simplify the structure of the POCT blood cell analyzer.

[0028] The POCT blood cell test kit of this embodiment has a specified service life and a recommended storage environment. The recommended storage environment is an environmental condition in which the reagents and materials in the test kit are not easy to deteriorate or decompose when the test kit is stored; the service life is the storage time of the test kit in the recommended storage environment. During the service life, the POCT blood cell test kit can be normally used as an auxiliary product of the POCT blood cell analyzer for detection to ensure the accuracy of its detection. Among them, the POCT blood cell test kit is usually provided with an outer packaging and / or instructions, and the outer packaging and / or instructions are printed with the recommended storage environment and service life of the test kit, so that the user can use the outer packaging and / or instructions to judge the storage conditions of the POCT blood cell test kit and the effectiveness of the test kit. Among them, the service life of this embodiment is 1 to 3 years, for example, the service life can be 1, 1.5, 2, 2.5 or 3 years; the recommended storage environment of this embodiment includes a temperature range of 2 to 30°C.

[0029] Within the service life of the POCT blood cell kit and the recommended storage environment, when the reagent in the reagent pool 13 is transferred to the impedance detection pool 12 for counting of particles precipitated from the kit, the number of precipitated particles represented by the white blood cell blank count result is no more than 0.5×10 9 / L, the number of precipitated particles represented by the blank red blood cell count result is no more than 0.05×10 12 / L, the number of precipitated particles represented by the platelet blank count result is no more than 10×10 9 / L. The above-mentioned number of precipitated particles characterized by the blank white blood cell count result, the blank red blood cell count result or the blank platelet count result is obtained by counting the precipitated particles of the POCT blood cell test kit through each detection channel of the POCT blood cell analyzer, and is not obtained by testing with a large blood cell analyzer. It can be understood that large blood cell analyzers usually have built-in components such as reagent storage and liquid path detection, and directly test the samples to be tested in several sample tubes through sampling, without the need for auxiliary testing using a POCT blood cell test kit.

[0030] Through multiple experiments, the applicant of this application has found that blank particle counting can be performed through each detection channel of the POCT blood cell analyzer to characterize the plastic particles of the POCT blood cell kit according to the white blood cell blank counting result, red blood cell blank counting result, or platelet blank counting result; moreover, the number of precipitated particles characterized by the white blood cell blank counting result is not greater than 0.5×10 9 / L, the number of precipitated particles characterized by the red blood cell blank counting result is not greater than 0.05×10 12 / L, and the number of precipitated particles characterized by the platelet blank counting result is not greater than 10×10 9 / L, the influence of the precipitated plastic particles in the POCT blood cell kit of this embodiment on the detection result is relatively low, the accuracy of the blood cell detection result is high, and the reliability of the POCT blood cell analyzer is improved.

[0031] Optionally, in one embodiment, the reagent pool 13 includes a diluent pool for storing diluent. When the diluent is transferred to the impedance detection pool 12 for counting the precipitated particles of the kit, the number of precipitated particles is characterized by the red blood cell blank counting result and / or the platelet blank counting result.

[0032] Specifically, when the POCT blood cell kit is only used for testing red blood cells and / or platelets, the reagent pool 13 includes a diluent pool for storing diluent. During the normal testing process of the POCT blood cell kit, the diluent can be used to dilute the test sample stored in the kit to increase the gap between blood cells (red blood cells, platelets, etc.) in the test sample and reduce phenomena such as cell aggregation. The POCT blood cell kit of this embodiment is pre-packaged with a preset volume of diluent in the diluent pool. After the diluent is stored within the service life of the POCT blood cell kit and under the recommended storage environment, the POCT blood cell kit precipitates some plastic particles into the diluent. At this time, the diluent is transferred to the impedance detection pool 12 for blank particle counting of the kit, and the number of precipitated particles is characterized by the red blood cell blank counting result and / or the platelet blank counting result. When the number of precipitated particles characterized by the red blood cell blank counting result is not greater than 0.05×10 12 / L and / or the number of precipitated particles characterized by the platelet blank counting result is not greater than 10×10 9 / L, the influence of the precipitated plastic particles in the diluent on the detection result is relatively low, the accuracy of the blood cell detection result is high, and the reliability of the POCT blood cell analyzer is improved.

[0033] In another embodiment, the reagent pool 13 includes a diluent pool and a hemolytic agent pool. The diluent pool is used to store the diluent, and the hemolytic agent pool is used to store the hemolytic agent. When the diluent and the hemolytic agent are transferred to the impedance detection pool 12 for counting the precipitated particles of the reagent kit, the number of precipitated particles is characterized by the white blood cell blank count result.

[0034] Specifically, when the POCT blood cell reagent kit is only used for testing white blood cells, the reagent kit includes a diluent pool and a hemolytic agent pool. The diluent pool is used to store the diluent, and the hemolytic agent pool is used to store the hemolytic agent. The diluent can be used as a medium for diluting the sample to be tested, and the hemolytic agent is used to rupture red blood cells, resulting in the release of hemoglobin and its cellular contents. Due to the excessive number of red blood cells, during the normal testing process of the POCT blood cell reagent kit, it is necessary to dilute the sample to be tested with the diluent and then use the hemolytic agent to rupture the red blood cells and perform the white blood cell counting test to reduce the interference of red blood cells. In this embodiment of the POCT blood cell reagent kit, the diluent is pre-encapsulated in the diluent pool and the hemolytic agent is pre-encapsulated in the hemolytic agent pool. After storage for a preset life time under the recommended storage environment, the POCT blood cell reagent kit precipitates some plastic particles into the diluent and the hemolytic agent.

[0035] At this time, the diluent and the hemolytic agent are transferred to the impedance detection pool 12 for blank particle counting of the reagent kit, and the number of precipitated particles is characterized by the white blood cell blank count result. When the number of precipitated particles characterized by the white blood cell blank count result is not greater than 0.5×10 9 / L, the influence of the plastic particles precipitated in the diluent and the hemolytic agent on the test result is relatively low, the accuracy of the blood cell test result is high, and the reliability of the POCT blood cell analyzer is improved.

[0036] In other embodiments, when the POCT blood cell reagent kit can be used for testing white blood cells, red blood cells or platelets, the reagent kit includes a diluent pool and a hemolytic agent pool. The POCT blood cell analyzer can also perform blank counting of red blood cells or platelets in the sample to be tested in the reagent kit to characterize the plastic particles. At this time, the diluent is transferred to the impedance detection pool 12 for counting the precipitated particles of the reagent kit, and the number of precipitated particles can also be characterized by the red blood cell blank count result and / or the platelet blank count result, which will not be elaborated here.

[0037] Optionally, in one embodiment, the impedance detection pool 12 is used to perform red blood cell blank counting on the precipitated particles of the reagent kit, and the diameter range of the precipitated particles of the reagent kit is 6-9.5 μm.

[0038] Specifically, the diameters of the plastic particles precipitated from the plastic material vary. When the impedance detection cell 12 is used to perform a red blood cell blank count on the precipitated particles of the test kit, the POCT blood cell analyzer counts the precipitated particles of the test kit in the diluent in the impedance detection cell 12 through the red blood cell counting channel. The diameter range of the precipitated particles of the test kit is 6-9.5 μm, and the number of precipitated particles characterized by the red blood cell blank count result is not more than 0.05×10 12 / L. That is, the number of plastic particles with diameters in the range of 6-9.5 μm is less than or equal to 0.05×10 12 / L, and the plastic particles outside the range of 6-9.5 μm can be approximately understood as having no influence on the red blood cell count, and the POCT blood cell analyzer will not mistake the plastic particles outside the range for red blood cells. At this time, the influence of the plastic particles precipitated in the diluent on the red blood cell detection result is low, the accuracy of the blood cell detection result is high, and the reliability of the POCT blood cell analyzer is improved.

[0039] In another embodiment, the impedance detection cell 12 is used to perform a white blood cell blank count on the precipitated particles of the test kit, and the diameter range of the precipitated particles of the test kit is 2-20 μm.

[0040] Similarly, when the impedance detection cell 12 is used to perform a white blood cell blank count on the precipitated particles of the test kit, the POCT blood cell analyzer counts the precipitated particles of the test kit in the diluent and hemolytic agent in the impedance detection cell 12 through the white blood cell counting channel. At this time, the diameter range of the precipitated particles of the test kit is 2-20 μm, and the plastic particles outside the range of 2-20 μm can be approximately understood as having no influence on the white blood cell count. Therefore, the number of plastic particles with diameters in the range of 2-20 μm is less than or equal to 0.5×10 9 / L, and the influence of the plastic particles precipitated in the diluent and hemolytic agent on the white blood cell detection result is low, the accuracy of the blood cell detection result is high, and the reliability of the POCT blood cell analyzer is improved.

[0041] In yet another embodiment, the impedance detection cell 12 is used to perform a platelet blank count on the precipitated particles of the test kit, and the diameter range of the precipitated particles of the test kit is 2-4 μm.

[0042] Similarly, when the impedance detection cell 12 is used to perform a platelet blank count on the precipitated particles of the test kit, the POCT blood cell analyzer counts the precipitated particles of the test kit in the diluent in the impedance detection cell 12 through the platelet counting channel. At this time, the diameter range of the precipitated particles of the test kit is 2-4 μm, and the plastic particles outside the range of 2-4 μm can be approximately understood as having no influence on the platelet count. Therefore, the number of plastic particles with diameters in the range of 2-4 μm is less than or equal to 10×10 9 / L, the plastic particles precipitated in the diluent have a low impact on the platelet test results, the accuracy of the blood cell test is high, and the reliability of the POCT blood cell analyzer is improved.

[0043] Optionally, the reagent pool 13 is filled with a reagent of a preset liquid volume. After being stored for a preset time period, the liquid volume of the reagent in the reagent pool 13 is the first liquid volume, and the difference between the preset liquid volume and the first liquid volume is not greater than 5% of the preset liquid volume.

[0044] Specifically, the reagent pool 13 is filled with a reagent of a preset liquid volume. The reagent can be a diluent and / or a lysing agent. After being stored for a preset time period, the reagent in the reagent pool 13 will have a liquid volume loss due to partial volatilization. At this time, the liquid volume of the reagent is recorded as the first liquid volume, and the difference between the preset liquid volume and the first liquid volume is not greater than 5% of the preset liquid volume. For example, the difference between the preset liquid volume and the first liquid volume can be 1%, 2%, 3%, 4%, or 5% of the preset liquid volume.

[0045] Among them, the above-mentioned preset time period can be the service life time of the POCT blood cell test kit in the recommended storage environment, or other times outside the recommended storage environment after conversion, so as to characterize the liquid volume difference within the service life time through the liquid volume difference of the converted other times. For example, the preset time period is to be stored at 2 - 30°C for 2 years, or the preset time period can also be to be stored at 30 - 56°C for 1 month - 12 months, which is not specifically limited here.

[0046] In this embodiment, when the difference between the preset liquid volume and the first liquid volume is not greater than 5% of the preset liquid volume, the POCT blood cell test kit of this embodiment can slow down the volatilization of the reagent in the reagent pool 13, has good anti-volatilization performance, is suitable for long-term storage, and has high practicability.

[0047] Optionally, the impedance detection cell 12 is used to transmit the detection light beam so that the detection light beam performs optical detection on the detection sample, and the light transmittance of the impedance detection cell 12 is greater than or equal to 80%.

[0048] Specifically, the POCT blood cell kit can also cooperate with a POCT blood cell analyzer for optical testing. At this time, the impedance detection cell 12 can be used as the site for optical detection. The detection beam emitted by the POCT blood cell analyzer needs to pass through the impedance detection cell 12 and irradiate the sample to be tested to obtain the results of optical testing. In an optional embodiment, the transmittance test of the impedance detection cell 12 can be performed by the haze meter method and / or the spectrophotometer method; the transmittance of the impedance detection cell 12 is greater than or equal to 80%. For example, the transmittance of the impedance detection cell 12 can be 80%, 82%, 84%, 86%, 88%, 90%, 94%, 98% or 100%. In an optional embodiment, the transmittance of the detection cell of the kit and other cell bodies can be the same or different.

[0049] Optionally, the reagent cell 13 is used to store the diluent and / or hemolytic agent for a preset period of time; wherein, the pH value range of the diluent is 7.4-7.8, the conductivity range of the diluent is 1550-1650 mS / m, the osmotic pressure range of the diluent is 300-320 mOsm / Kg, and the pH value range of the hemolytic agent is 4.0-4.4.

[0050] Specifically, the pH value of the stored diluent can be 7.4, 7.5, 7.6, 7.7 or 7.8, the conductivity of the stored diluent can be 1550, 1570, 1600, 1620 or 1650 mS / m, the osmotic pressure of the stored diluent can be 300, 305, 310, 315 or 320 milliosmole (mOsm / Kg), and the pH value of the stored hemolytic agent can be 4.0, 4.1, 4.2, 4.3 or 4.4. When the physical and chemical properties of the diluent and / or hemolytic agent after being stored for a preset period of time still remain within the above range, it can be understood that the properties of the stored reagent are still relatively stable, so that the stored reagent can be normally used for the testing of red blood cells, platelets or white blood cells, improving the reliability of the results of POCT blood cell detection.

[0051] Among them, the above preset period can be the service life time of the POCT blood cell kit in the recommended storage environment, or other time outside the recommended storage environment after conversion, and the liquid volume difference within the service life time is characterized by the liquid volume difference of the other time after conversion. For example, the preset period is to store for 2 years at 2-30°C, or the preset period can also be to store for 1-12 months at 30-56°C, which is not specifically limited here.

[0052] Optionally, the material of the box body 11 includes homopolypropylene or block copolymerized polypropylene.

[0053] Specifically, the material of the cartridge body 11 for manufacturing the POCT blood cell test kit includes homopolypropylene or block copolymerized polypropylene. In one embodiment, the cartridge body 11 is made of homopolypropylene (PP-H). Homopolypropylene is polymerized from a single propylene monomer and does not contain ethylene monomers in its molecular chain. The strength of homopolypropylene is relatively good, so that the cartridge body 11 of the POCT blood cell test kit has high strength. In another embodiment, the cartridge body 11 is made of block copolymerized polypropylene (PP-B). Block copolymerized polypropylene has a relatively high ethylene content and good impact resistance, making the POCT blood cell test kit more stable.

[0054] Please refer to Figure 2 , Figure 2 which is a schematic flowchart of an embodiment of the material selection method provided by this application. As Figure 2 shown, the material selection method of this embodiment includes the following steps:

[0055] Step S11: Encapsulate the reagent with multiple materials to obtain multiple test cartridges, and store the test cartridges for a preset period of time.

[0056] Specifically, the material selection method of this embodiment is applied to the material selection of the POCT blood cell test kit in any of the above embodiments, and can be specifically applied to the cartridge body 11 of the test kit. This material selection method can prepare multiple test cartridges from multiple materials in the selected material list. For example, in order to meet the light transmittance requirements of the POCT blood cell test kit, the materials in the material list can be a material list with a light transmittance greater than or equal to the first preset threshold. The first preset threshold can be 80%, and the material list includes materials such as polypropylene, polystyrene, polycarbonate, acrylonitrile-butadiene-styrene plastic, and polymethyl methacrylate. Polypropylene (PP) is a polymer formed by the addition polymerization of propylene. Polystyrene (PS) is a polymer synthesized by the free radical addition polymerization of styrene monomers. Polycarbonate (PC) is a high molecular polymer containing carbonate groups in its molecular chain. Acrylonitrile-butadiene-styrene plastic (ABS) is a terpolymer formed by the polymerization of acrylonitrile, butadiene, and styrene monomers. Polymethyl methacrylate (PMMA) is a polymer obtained by the polymerization of acrylic acid and its esters.

[0057] The shape of the test cartridge can correspond to that of the reagent kit. The test cartridge is encapsulated with reagents, which include but are not limited to reagents such as diluents, hemolyzing agents, cleaning solutions, etc. After obtaining multiple test cartridges encapsulated with reagents, the test cartridges are placed under preset environmental conditions for storage for a preset period of time. In an alternative embodiment, the preset period of time can be the service life of the POCT hematology reagent kit under the recommended storage environment, or it can be other time converted outside the recommended storage environment, and the liquid volume difference within the service life is characterized by the liquid volume difference of the converted other time. For example, the preset period of time is to store for 2 years at 2 - 30°C, or the preset period of time can also be to store for 1 - 12 months at 30 - 56°C, and specific limitations are not made here.

[0058] Step S12: Count the number of precipitated particles in the reagents in the stored test cartridges to obtain the number of precipitated particles in the reagents in multiple test cartridges. The number of precipitated particles is characterized by at least one of the red blood cell blank count result, white blood cell blank count result, and platelet blank count result.

[0059] Specifically, the counting of precipitated particles in the reagent kit is used to perform a blank count test on the plastic particles in the reagent, so as to analyze the influence degree of the plastic particles in the reagent on the blood cell analysis result through the counting result of precipitated particles in the reagent kit. In an alternative embodiment, the counting of precipitated particles in the reagent kit can be to perform a particle counting test on the reagent. The number of precipitated particles is characterized by at least one of the red blood cell blank count result, white blood cell blank count result, and platelet blank count result.

[0060] Step S13: Use the material with the number of precipitated particles not greater than the second preset threshold as the box body material of the POCT hematology reagent kit.

[0061] Specifically, when the number of precipitated particles is characterized by the red blood cell blank count result, the second preset threshold can be 0.05×10 12 / L; when the number of precipitated particles is characterized by the white blood cell blank count result, the second preset threshold can be 0.5×10 9 / L; when the number of precipitated particles is characterized by the platelet blank count result, the second preset threshold can be 10×10 9 / L.

[0062] When the number of precipitated particles in the test cartridge of a certain material is not greater than the second preset threshold, that is, the influence degree of the precipitate of this material on the blood cell analysis result is relatively small, this material can be used as the box body material suitable for making the reagent kit. When the reagent kit prepared with the box body material stores the reagent, the adverse effects caused by the precipitation of plastic particles are relatively low.

[0063] In the embodiments of the present application, by counting the precipitated particles of the reagent in the stored test kit, a material with the number of precipitated particles not greater than the second preset threshold is selected as the box body material, so as to reduce the adverse effects caused by the precipitation of plastic particles when the test kit stores the reagent, and improve the accuracy of the results of sample detection using the test kit subsequently.

[0064] Optionally, after step S11, the material selection method further includes: analyzing the physical and chemical properties of the reagent in the stored test kit to obtain the characteristic analysis results of the reagents in multiple test kits. Step S14 includes: using the material of the test kit with the characteristic analysis results within the preset range and the number of precipitated particles not greater than the second preset threshold as the box body material.

[0065] Specifically, the physical and chemical property analysis is to analyze the common physical and chemical properties of the reagent. For example, the physical and chemical property analysis includes testing at least one of the physical and chemical properties of pH value, conductivity, and osmotic pressure of the reagent. The material selection method of this embodiment analyzes the physical and chemical properties of the stored reagent to obtain the characteristic analysis results of the reagents in multiple test kits. When selecting the box body material suitable for making the test kit, the material with the characteristic analysis results within the preset range and the number of precipitated particles not greater than the second preset threshold in the material list is used as the box body material.

[0066] In an optional implementation manner, the preset range of the pH value is between 7.4 and 7.8, the preset range of the conductivity is between 1550 and 1650 mS / m, and the preset range of the osmotic pressure is between 300 and 320 mOsm / Kg. It can be understood that the preset range is related to the reagent components of the reagent, the storage environmental conditions, etc. When the components of the reagent change, the above preset range can be adjusted, and no specific limitation is made here.

[0067] When the characteristic analysis results of the reagents in multiple stored test kits are within the preset range, after the test kits store the reagent for a preset period of time, the properties of the reagent in the test kits are relatively stable, so as to ensure that the stored reagent can be used for blood routine detection and improve the reliability of the test kit.

[0068] Optionally, after step S11, the material selection method further includes: testing the evaporation amount of the reagent in the stored test kit to obtain the evaporation amount test results of the reagents in multiple test kits. Specifically, the evaporation amount test is to test the evaporation amount in the stored test kit, and the evaporation amount test result can be the liquid volume difference of the reagent before and after storage. The material selection method of this embodiment tests the evaporation prevention performance of the material of the test kit by testing the evaporation amount of the reagent in the stored test kit.

[0069] Step S12 includes: encapsulating a reagent with a preset liquid volume using the materials in the material list. Step S13 includes: in response to the characteristic analysis result of the material being within a preset range, the number of precipitated particles being not greater than a second preset threshold, and the evaporation amount test result being not greater than a third preset threshold, using the qualified material as the cartridge material. Among them, the evaporation amount test result can be calculated by obtaining the reagent liquid volume in the test cartridge after storage. Denote the reagent liquid volume in the test kit after storage as the first liquid volume, then the evaporation amount test result of the reagent is the difference between the preset liquid volume and the first liquid volume, and the third preset threshold is 5% of the preset liquid volume.

[0070] Since the characteristic analysis result of the cartridge material is within the preset range, the test kit prepared from the cartridge material can stably store the reagent to ensure that the stored reagent can be used for blood routine testing; the number of precipitated particles of the cartridge material is not greater than the second preset threshold, so the influence of plastic particle precipitation during the storage of the reagent by the test kit prepared from the cartridge material is relatively low, and the result accuracy of the sample testing by the test kit is relatively high; the evaporation amount test result of the cartridge material is not greater than the third preset threshold, that is, the cartridge material can reduce liquid evaporation, so the anti-evaporation performance of the test kit prepared from the cartridge material is good, and this test kit is suitable for single use.

[0071] Optionally, in one embodiment, please refer to Figure 3 , Figure 3 which is a schematic flowchart of another embodiment of the material selection method provided by this application. As Figure 3 shown, the material selection method of this embodiment includes the following steps:

[0072] Step S31: Conduct a light transmittance test on a preset variety of materials to obtain a list of materials with a light transmittance greater than or equal to a first preset threshold.

[0073] Step S32: Encapsulate the reagent using the materials in the material list to obtain a plurality of test cartridges, and store the test cartridges for a preset period of time.

[0074] Step S33: Conduct a physical and chemical property analysis on the reagent in the stored test cartridge to obtain the characteristic analysis results of the reagent in a plurality of test cartridges.

[0075] Step S34: Conduct an evaporation amount test on the reagent in the stored test cartridge to obtain the evaporation amount test results of the reagent in a plurality of test cartridges.

[0076] Step S35: Count the precipitated particles of the reagent in the stored test cartridge to obtain the number of precipitated particles of the reagent in a plurality of test cartridges.

[0077] Step S36: In response to the results of the material property analysis being within a preset range, the number of precipitated particles being not greater than a second preset threshold, and the volatilization amount test result being not greater than a third preset threshold, the material that meets the requirements is used as the cartridge material.

[0078] In this embodiment, the reagent after being stored for a preset period of time can be sequentially subjected to physical and chemical property analysis, volatilization amount test, and counting of precipitated particles in the reagent kit, so as to select a material with better stability, anti-volatility, and less influence of precipitates from the material list as the cartridge material, improve the reliability of the POCT blood cell reagent kit, and ensure the result accuracy of the POCT blood cell reagent kit during sample detection.

[0079] In another embodiment, the physical and chemical property analysis, volatilization amount test, and counting of precipitated particles in the reagent kit can be performed simultaneously, or the order of the physical and chemical property analysis, volatilization amount test, and counting of precipitated particles in the reagent kit can be adjusted according to actual needs, which is not specifically limited herein.

[0080] Optionally, step S13 includes: performing a complete blood count test on the stored reagent and a blank sample through a POCT blood cell analyzer, and using the result of the complete blood count test as the number of precipitated particles.

[0081] Specifically, after the reagent is stored in the test kit for a preset period of time, a complete blood count test is performed on the stored reagent and a blank sample through a POCT blood cell analyzer, and the result of the complete blood count test is used as the number of precipitated particles. Among them, the blank sample is a pure water sample. For example, the blank sample can be RO pure water or EDI pure water. The POCT blood cell analyzer can input the mixed solution of the reagent and the blank sample into the corresponding complete blood count test channel to obtain the complete blood count test result. The complete blood count test channel can include at least one of a red blood cell count channel, a white blood cell count channel, and a platelet count channel.

[0082] The embodiment of the present application also provides a POCT blood cell analyzer, including a detection seat and a detection component. The detection seat is used to receive the reagent kit as described above. The detection component is arranged on the detection seat and is used to perform a complete blood count test on the test sample of the reagent kit.

[0083] Among them, the reagent kit includes a reagent pool 13 and an impedance detection pool 12. During the service life of the POCT blood cell reagent kit and under the recommended storage environment, the reagent in the reagent pool 13 is transferred to the impedance detection pool 12, and the detection component is used to perform counting of precipitated particles in the reagent and the blank sample in the impedance detection pool 12 to obtain the number of precipitated particles in the POCT blood cell reagent kit.

[0084] Specifically, the detection base is used to install or receive the kit of any of the above embodiments for operations such as pipetting and sample detection through the kit. The detection component is used to detect the sample in the kit. In an optional embodiment, the POCT blood cell analyzer further includes a pipetting component, which is used to add the reagent in the reagent pool 13 of the kit to the detection pool to mix the reagent with the blank sample, and the detection component is used to perform a complete blood count test on the mixed solution of the reagent and the blank sample in the detection pool. The complete blood count test includes at least one of a red blood cell count test, a white blood cell count test, and a platelet count test. Among them, the kit of this embodiment is used to store the reagent. The above blank sample can be a pure water sample stored in the kit synchronously with the reagent, or a pure water sample can be added to the kit after a preset storage period so that the pipetting component can perform pipetting and detection.

[0085] When the white blood cell blank count result of the reagent is less than or equal to 0.5×10 9 / L, the red blood cell blank count result of the reagent is less than or equal to 0.05×10 12 / L, and / or the platelet blank count result of the reagent is less than or equal to 10×10 9 / L, the influence degree of the precipitate of this material on the blood cell analysis result is small, and the applicability of this material in manufacturing the kit is high. When using the box body material selected from the material list to prepare the kit, the influence of the plastic particles precipitated during the storage of the kit on the detection result is low, the accuracy of the blood cell detection result is improved, and the reliability of the POCT blood cell analyzer is improved.

[0086] Example 1:

[0087] In this embodiment, the materials in the material list are used to encapsulate the reagent to obtain multiple test kits, and the test kits are stored for a preset period of time to perform the counting of the precipitated particles and the volatilization amount test on the stored reagent. The test results of the number of precipitated particles and the volatilization amount are shown in Table 1. Specifically, the material list includes PP, PS, PC, ABS, and PMMA; the counting of the precipitated particles in the kit includes the red blood cell blank count result (RBC), the white blood cell blank count result (WBC), the platelet blank count result (PLT), and the hemoglobin blank count result (HGB); the volatilization amount test results include the first volatilization amount measured after 10 days of storage and the second volatilization amount measured after 20 days of storage.

[0088] Among them, the counting unit of the above WBC result is 10 9 / L, the counting unit of the RBC result is 10 12 / L, and the counting unit of the PLT result is 10 9 / L, the counting unit of the HGB result is g / L. When counting the precipitated particles of the reagent in the kit in this embodiment, 3 repeated tests are carried out in the same detection channel, and the average value of the 3 test results is used as the test result in Table 1; moreover, the liquid volume of the reagent added during the evaporation amount test is 5000 ul, and the third preset threshold for passing the evaporation amount test can be 5000 * 5% = 250 ul. For example, when performing white blood cell counting on the reagent of the PP test kit, the 3 test results obtained are 0.03, 0.04, and 0.03 respectively, and the average value of the 3 test results is 0.033.

[0089] Table 1: Precipitated particle quantity and evaporation amount test results of multiple test kits

[0090]

[0091]

[0092] As can be seen from the above table, the WBC test result of the reagent of the PP test kit is 0.033×10 9 / L, less than 0.5×10 9 / L; the RBC test result is 0.0067×10 12 / L, less than 0.05×10 12 / L; the PLT test result is 5×10 9 / L, less than 10×10 9 / L. That is, the plastic particles precipitated in the reagent of the PP test kit have little influence on white blood cell counting, red blood cell counting, and platelet counting. The plastic particles precipitated in the reagent of the PP test kit have no influence on hemoglobin counting, and the quantity of precipitated particles of the reagent of the PP test kit meets the standard. Moreover, the evaporation amounts of the reagent of the PP test kit when stored for 10 days and 20 days are much less than 250 ul, and the anti-evaporation performance of the PP test kit is good. Polypropylene can be used as the box body material suitable for making test kits.

[0093] In the PS test kit, the WBC test result, RBC test result, and PLT test result of the reagent all do not meet the conditions. The plastic particles precipitated in the reagent of the PS test kit have a greater influence on blood cell counting, resulting in a decrease in the accuracy of the test results; moreover, the evaporation amount of the reagent of the PS test kit when stored for 20 days is greater than the third preset threshold, and the anti-evaporation performance is not good. The WBC test result, RBC test result, PLT test result, first evaporation amount, and second evaporation amount of the reagent of the PC test kit do not meet the conditions. The WBC test result, RBC test result, PLT test result, and second evaporation amount of the reagent of the ABS test kit do not meet the conditions. The precipitation of plastic particles in the PC and ABS test kits has a greater influence on blood cell counting and poor anti-evaporation performance. In the PMMA test kit, the PLT test result is 1139×109 / L, far greater than 10×10 9 / L. The plastic particles precipitated therefrom have a great impact on the accuracy of platelet count, and the first volatilization amount and the second volatilization amount are far greater than the third preset threshold, resulting in poor anti-volatilization performance. Therefore, when selecting materials from the material list using the material selection method of the above embodiment, PS, PC, ABS, and PMMA are not suitable for making reagent kits.

[0094] Embodiment 2:

[0095] In this embodiment, homopolypropylene is used to encapsulate the reagent to obtain the first test kit; and block copolymer polypropylene is used to encapsulate the reagent to obtain the second test kit. The first test kit and the second test kit are stored for a preset period of time to count the precipitated particles of the reagent after storage, and the number of precipitated particles is shown in Table 2.

[0096] Table 2: Number of precipitated particles of the first test kit and the second test kit

[0097] WBC result RBC result PLT result HGB result The first test kit 0.016 0.42 2 0 The second test kit 0.015 0.43 2 0

[0098] Among them, the counting unit of the above WBC result is 10 9 / L, the counting unit of the RBC result is 10 12 / L, the counting unit of the PLT result is 10 9 / L, and the counting unit of the HGB result is g / L. When counting the precipitated particles of the reagent in this embodiment, 3 repeated tests are carried out in the same detection channel, and the average value of the 3 test results is used as the test result in Table 1. For example, when performing a white blood cell blank count on the reagent of the first test kit, the 3 test results obtained are 0.01, 0.05, and 0.02 respectively, and the average value of the 3 test results is 0.016.

[0099] It can be understood that in the first test kit and the second test kit, the WBC test results, RBC test results, and PLT test results of the reagent all meet the conditions; and, the plastic particles precipitated from the reagent in the first test kit and the second test kit have similar impacts on blood cell count. Both homopolypropylene and block copolymer polypropylene can be used as the box body materials for making POCT blood cell reagent kits, and users can choose according to actual usage requirements.

[0100] The above are only the embodiments of the present application, and do not limit the patent scope of the present application. Any equivalent structure or equivalent process transformation made using the content of the specification and drawings of the present application, or directly or indirectly applied in other related technical fields, shall be similarly included in the patent protection scope of the present application.

Claims

1. A POCT blood cell kit, characterized in that, it includes: a box body; an impedance detection cell, disposed in the box body; a reagent cell, disposed on a side of the box body away from the detection cell, and the reagent cell is used for storing reagents; During the service life of the POCT blood cell kit and under the recommended storage environment, when the reagent in the reagent pool is transferred to the impedance detection pool for counting the precipitated particles of the kit, the number of precipitated particles characterized by the white blood cell blank counting result is not greater than 0.5×10 9 / L, and the number of precipitated particles characterized by the red blood cell blank counting result is not greater than 0.05×10 12 / L, and the number of precipitated particles characterized by the platelet blank counting result is not greater than 10×10 9 / L.

2. The POCT blood cell kit according to claim 1, characterized in that, the reagent cell includes a diluent cell for storing a diluent, and when the diluent is transferred to the impedance detection cell for counting the precipitated particles of the kit, the number of the precipitated particles is characterized by the red blood cell blank count result and / or the platelet blank count result. Or, the reagent cell includes the diluent cell and a hemolytic agent cell, the diluent cell is used for storing the diluent, the hemolytic agent cell is used for storing a hemolytic agent, and when the diluent and the hemolytic agent are transferred to the impedance detection cell for counting the precipitated particles of the kit, the number of the precipitated particles is characterized by the white blood cell blank count result.

3. The POCT blood cell kit according to claim 2, characterized in that, the impedance detection cell is used for performing a red blood cell blank count on the precipitated particles of the kit, and the diameter range of the precipitated particles of the kit is 6 - 9.5 μm; Or, the impedance detection cell is used for performing a white blood cell blank count on the precipitated particles of the kit, and the diameter range of the precipitated particles of the kit is 2 - 20 μm; Or, the impedance detection cell is used for performing a platelet blank count on the precipitated particles of the kit, and the diameter range of the precipitated particles of the kit is 2 - 4 μm.

4. The POCT blood cell kit according to claim 1, characterized in that, the reagent cell is encapsulated with a preset volume of the reagent, and after being stored for a preset period of time, the volume of the reagent in the reagent cell is the first volume, and the difference between the preset volume and the first volume is not greater than 5% of the preset volume.

5. The POCT blood cell kit according to claim 1, characterized in that, the impedance detection cell is used for transmitting a detection light beam so that the detection light beam performs optical detection on a detection sample, and the light transmittance of the impedance detection cell is greater than or equal to 80%.

6. The POCT blood cell kit according to claim 1, characterized in that, the reagent cell is used for storing the diluent and / or the hemolytic agent for a preset period of time; wherein, the pH value range of the diluent is 7.4 - 7.8, the conductivity range of the diluent is 1550 - 1650 mS / m, the osmotic pressure range of the diluent is 300 - 320 mOsm / Kg, and the pH value range of the hemolytic agent is 4.0 - 4.

4.

7. The POCT blood cell kit according to claim 1, characterized in that, the material of the box body includes homopolypropylene or block copolymer polypropylene.

8. A material selection method for a POCT blood cell kit, characterized in that, applied to the POCT blood cell kit according to any one of claims 1 - 7, and the material selection method includes: using a variety of materials to encapsulate the reagent to obtain a plurality of test boxes, and storing the test boxes for a preset period of time; Perform particle counting on the reagent in the stored test kit to obtain the number of precipitated particles of the reagent in multiple test kits, where the number of precipitated particles is characterized by at least one of the red blood cell blank counting result, white blood cell blank counting result, and platelet blank counting result; Use the material with the number of precipitated particles not greater than the second preset threshold as the box body material of the POCT hematology test kit.

9. According to the material selection method described in claim 8, characterized in that, After the step of using multiple materials to encapsulate the reagent to obtain multiple test kits and storing the test kits for a preset period of time, the material selection method further includes: performing physicochemical property analysis on the reagent in the stored test kit to obtain the characteristic analysis results of the reagent in multiple test kits; or, performing a volatilization amount test on the reagent in the stored test kit to obtain the volatilization amount test results of the reagent in multiple test kits.

10. A POCT hematology analyzer, characterized in that, comprises: A detection seat for receiving the POCT hematology test kit according to any one of claims 1-7; A detection component arranged on the detection seat for performing a complete blood count test on the test sample or reagent of the POCT hematology test kit; Wherein, the test kit includes a reagent pool and an impedance detection pool. During the service life of the POCT hematology test kit and under the recommended storage environment, the reagent in the reagent pool is transferred to the impedance detection pool, and the detection component is used to perform particle counting on the reagent and blank sample in the impedance detection pool to obtain the number of precipitated particles of the POCT hematology test kit.

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