CN114935571A - A storage detection container, detection device and reagent kit - Google Patents

Abstract

The application discloses a storage detection container, wherein the top of the storage detection container (1) is provided with an opening, a first chamber (11) for storing dry reagent and a second chamber (12) for storing wet reagent are formed in the storage detection container (1), the second chamber (12) is positioned above the first chamber (11), and the first chamber (11) and the second chamber (12) are separated by a sealing film (13); the opening at the top of the storage detection container (1) is sealed by a sealing member. The application also provides a detection device and a glycosylated hemoglobin detection kit. The application provides a storage detection container, detection device and kit, not only be suitable for the external diagnosis field, also be applicable to other chemical analysis fields, the range of application is wide, long-term storage stable performance, and easy operation, convenient.

Description

A storage detection container, detection device and reagent kit

technical field

The present application relates to the technical field of detection equipment, and in particular, to a storage detection container, a detection device, and a reagent kit.

Background technique

In Vitro Diagnosis, or IVD (In Vitro Diagnosis), refers to products and services that obtain clinical diagnostic information by testing human samples (blood, body fluids, tissues, etc.) outside the human body, and then judge diseases or body functions.

Different detection targets use different diagnostic methods, and the same detection target can also be detected in multiple ways. According to whether large-scale testing equipment is required, testing methods can be divided into methods used for professional testing in hospital testing departments and laboratories, and methods suitable for point-of-care testing (POCT). Point-of-care testing refers to clinical testing and bedside testing performed next to the patient. By analyzing immediately at the sampling site, the complex processing procedures of specimens in laboratory testing are omitted, so as to quickly obtain test results.

Glycated hemoglobin (HbA1c) is the product of the combination of hemoglobin in red blood cells with carbohydrate metabolites in serum. It is formed through a slow, continuous and irreversible glycation reaction, and its content depends on the blood sugar concentration and the contact time between blood sugar and hemoglobin. It is higher than blood sugar, so glycated hemoglobin can reflect the blood sugar changes of the patient in the past two months, and it is an important indicator to reflect the quality of blood sugar control of the patient for a long period of time. Glycated hemoglobin has become the gold standard for diagnosing diabetes. The normal range of glycated hemoglobin in normal people is 4%-6%. The Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 edition) officially included "glycated hemoglobin" in the diagnostic criteria of diabetes for the first time.

There are many methods for the determination of glycosylated hemoglobin. At present, the most commonly used methods in clinical practice are as follows: latex agglutination method, ion exchange high pressure liquid chromatography, boric acid affinity method, and spectrophotometry. These methods have been applied to various biochemical analysis. on the instrument.

Among them, the latex agglutination reaction method is to directly measure the percentage of glycated hemoglobin HbA1c in the total hemoglobin by using antigen-antibody specific reaction. Obviously not suitable for home use, and not very suitable for point-of-care testing (POCT) scenarios. Chromatography utilizes the chemical properties of substances, separates them through chromatographic columns or chromatographic paper, and then conducts testing, which also requires the use of more complex testing equipment. The boric acid affinity method utilizes the specific reaction of boric acid with glucose molecules to measure glycosylated hemoglobin. In order to eliminate the influence of glucose in the sample, it is necessary to separate out the non-specific reaction glucose, and the test process requires multiple steps to complete the test.

The spectrophotometric method uses protease to cleave the N-terminal of hemoglobin β chain to release glycated dipeptide, and fructosyl peptide oxidase acts on the glycated dipeptide to generate hydrogen peroxide; in the presence of peroxidase, hydrogen peroxide and chromogenic reagent A color reaction is generated, and the content of glycosylated hemoglobin can be detected by a spectrophotometer, and the process is relatively simple. However, spectrophotometry needs to react the sample with the reaction reagent in a test tube, pour it into a cuvette and then put it into a spectrophotometer for detection, which is not suitable for household and POCT scenarios.

Therefore, how to provide a detection device that is simple to operate and suitable for household and POCT scenarios to meet the growing demand for household and POCT glycosylated hemoglobin testing is a technical problem to be solved by those skilled in the art.

SUMMARY OF THE INVENTION

In order to solve the above technical problems, the purpose of the present invention is to provide a storage detection container, a detection device using the above storage detection container, and a glycosylated hemoglobin detection kit; the storage detection container, detection device and kit provided by the application are not only suitable for in vitro In the field of diagnosis, it is also suitable for other chemical analysis fields, with a wide range of applications, stable long-term storage performance, and easy and convenient operation.

The technical scheme provided by the present invention is as follows:

A storage detection container, the top of the storage detection container has an opening, and a first chamber for storing dry reagents and a second chamber for storing wet reagents are formed in the storage detection container,

the second chamber is located above the first chamber, and the first chamber and the second chamber are separated by a sealing film;

The opening at the top of the storage test container is sealed by a seal.

Preferably, the seal is a sealing membrane and/or a removable cover.

Preferably, the storage detection container is formed by assembling a first casing and a second casing, the first chamber is located in the first casing, and the second chamber is located in the second casing; the first casing The top of the body and the bottom of the second shell are respectively provided with sealing films.

Preferably, the storage detection container is formed by assembling a main body case and a base, the first chamber and the second chamber are both located in the main body case; the base is connected to the bottom of the main body case and seals the first chamber a chamber.

Preferably, at least two sides of the first chamber are parallel, and the two parallel sides are made of light-transmitting material; or,

At least two adjacent side surfaces of the first chamber are plane, and both adjacent two side surfaces are made of light-transmitting materials.

A detection device, comprising a storage detection container and a sampler, wherein the storage detection container is the storage detection container described in any one of the above;

The sampler can be inserted into the storage testing container to pierce the sealing film and inject the sample into the storage testing container.

Preferably, the sampler is a quantitative sampler, and the quantitative sampler includes a capillary tube, a reaming part and a hand-held part, both ends of the capillary are in contact with the outside air; the reaming part surrounds the outer periphery of the capillary Provided, the capillary tube and the reaming part can extend into the storage detection container and pierce the sealing membrane; the hand-held part is connected with the capillary tube and/or the sealing membrane.

Preferably, the reaming member includes at least one reaming plate, the lower part of the reaming plate is connected to the side wall of the capillary, and the top of the reaming plate is connected to the hand-held part.

Preferably, the radial dimension of the reaming plate gradually shrinks from the top to the bottom.

A glycosylated hemoglobin detection kit, using the detection device described in any one of the above to store reagents and add samples, wherein the dry reagent R1 stored in the first chamber includes protease, hydrogen peroxide, fructosyl Peptide oxidase, hydrogen peroxide color reagent;

The wet reagent R2 stored in the second chamber includes water, preservatives.

The application first provides a storage detection container, the top of the storage detection container has an opening, and the interior is separated by a sealing film to form a first chamber and a second chamber, and the two chambers store dry reagents and wet reagents respectively. , the two reagents are separated by the sealing film and will not react, the shelf life of the reagent is long, and the performance of the reagent is stable; the sealing film is destroyed by external force during use, and the wet reagent enters the first chamber and mixes with the dry reagent to form a detection reagent, which can be mixed with the sample. The specific components to be detected react in the sample to realize the detection of the sample. The storage detection container provided in this application has a long shelf life of the reagent, convenient transportation, storage and use, and can be applied to the storage and reaction of reagents in various fields.

The present application also provides a detection device, comprising the above-mentioned storage detection container and a sampler. The sampler is inserted into the storage detection container to pierce the sealing film, and the sample is injected into the storage detection container, thereby destroying the sealing film and allowing the wet reagent R2 is mixed with dry reagent R1 and reacts with the sample. The detection device provided in this application is not only suitable for in vitro diagnosis but also for other chemical analysis fields. .

The application also provides a glycosylated hemoglobin detection kit and a method of using the same.

Description of drawings

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following briefly introduces the accompanying drawings required for the description of the embodiments or the prior art. Obviously, the drawings in the following description are only These are some embodiments described in this application. For those of ordinary skill in the art, other drawings can also be obtained based on these drawings without any creative effort.

1 is a schematic structural diagram of a detection device in an embodiment of the present invention;

2 is a schematic cross-sectional view of a detection device in an embodiment of the present invention;

3 is a schematic structural diagram of a storage detection container in an embodiment of the present invention;

Fig. 4 is the exploded schematic diagram of Fig. 3;

5 is a schematic structural diagram of a quantitative sampler in an embodiment of the present invention;

6 is a schematic cross-sectional view of the first embodiment of the storage detection container in the embodiment of the present invention (the first housing and the second housing are assembled);

7 is a schematic cross-sectional view of the first embodiment of the storage detection container in the embodiment of the present invention (the first shell and the second shell are separated)

Fig. 8 is the partial enlarged schematic diagram of Fig. 6;

9 is a schematic cross-sectional view of the second embodiment of the storage detection container in the embodiment of the present invention (the main body shell and the base are assembled);

10 is a schematic cross-sectional view of the second embodiment of the storage detection container in the embodiment of the present invention (the main body shell is separated from the base);

Fig. 11 is the partial enlarged schematic diagram of Fig. 9;

Fig. 12 is the absorption spectrum diagram of hemoglobin (Hb) and the glycated part (GHb) of hemoglobin in the embodiment of the present invention;

Reference numerals: 1-storage detection container; 11-first chamber; 12-second chamber; 13-sealing film; 14-first case; 15-second case; 16-body case; 17 - base; 2 - quantitative sampler; 21 - capillary; 22 - reaming part; 221 - reaming plate; 23 - hand-held part.

Detailed ways

In order to make those skilled in the art better understand the technical solutions in the present application, the technical solutions in the embodiments of the present application will be described clearly and completely below. Obviously, the described embodiments are only a part of the embodiments of the present application. , not all examples. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present application.

It should be noted that when an element is referred to as being "fixed" or "disposed on" another element, it can be directly or indirectly disposed on the other element; when an element is referred to as being "connected" "to" another element, it may be directly connected to another element or indirectly connected to another element.

It is to be understood that the terms "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", The orientation or positional relationship indicated by "bottom", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present application and simplifying the description, rather than indicating or implying the indicated device or Elements must have a particular orientation, be constructed and operate in a particular orientation and are therefore not to be construed as limitations on this application.

In addition, the terms "first" and "second" are only used for descriptive purposes, and should not be construed as indicating or implying relative importance or implying the number of indicated technical features. Thus, a feature defined as "first" or "second" may expressly or implicitly include one or more of that feature. In the description of this application, "a plurality" and "several" mean two or more, unless otherwise expressly and specifically defined.

It should be noted that the structures, proportions, sizes, etc. shown in the drawings of this specification are only used to cooperate with the contents disclosed in the specification for the understanding and reading of those who are familiar with this technology, and are not used to limit the conditions that the application can implement. Therefore, it has no technical substantive significance. Any structural modification, proportional relationship change or size adjustment should still fall within the scope of the disclosure in this application, without affecting the effect that the application can produce and the purpose that can be achieved. The technical content must be able to cover the scope.

As shown in the figure, an embodiment of the present invention provides a storage detection container. The storage detection container 1 has an opening at the top, and a first chamber 11 for storing dry reagents is formed in the storage detection container 1. second chamber 12 for wet reagents,

The second chamber 12 is located above the first chamber 11, and the first chamber 11 and the second chamber 12 are separated by a sealing film 13;

The opening at the top of the storage testing container 1 is sealed by a sealing member.

The present application first provides a storage testing container. The top of the storage testing container 1 has an opening and is sealed by a sealing member. At the same time, the interior is separated by a sealing film 13 to form a first chamber 11 and a second chamber 12. The two chambers store dry Reagents and wet reagents, when stored, the two reagents are separated by the sealing film 13 and will not react, the shelf life of the reagents is long, and the performance of the reagents is stable; the sealing film is destroyed by external force during use, and the wet reagents enter the first chamber 11 It is mixed with the dry reagent to form a detection reagent, which can react with the specific components to be detected in the sample to realize the detection of the sample. The storage detection container provided in this application has a long shelf life of the reagent, convenient transportation, storage and use, and can be applied to the storage and reaction of reagents in various fields.

The sealing film 13 should be stable, hermetic, and easy to pierce. Stability, the sealing film 13 itself is made of relatively stable and non-deteriorating materials; after sealing, it will not react with the reagent; at the same time, the position where the sealing film 13 is provided has good sealing, the reagent will not leak, and there will be no air. and easy to pierce, the capillary can easily pierce the sealing membrane, which is convenient for detection operations. The material of the sealing film 13 can be selected from conventional materials in the art to achieve the above-mentioned functions.

The present application defines that the second chamber 12 stores wet reagents, and the first chamber 11 stores dry reagents, then when the sealing film 13 between the first chamber 11 and the second chamber 12 is broken, the second chamber 12 The wet reagent R2 in the inside is easy to quickly fall into the first chamber 11, and can be fully mixed with the dry reagent R1 in the first chamber 11. At the same time, the wet reagent R2 has less adhesion residue in the second chamber 12, which can ensure that every Reagent dosage should be as precise as possible.

Dry reagent R1 is in dry powder form, which can prolong the shelf life; while wet reagent R2 is liquid and should have a longer shelf life for dissolving dry reagent R1. Further preferably, the dry reagent R1 is a detection reagent, and the wet reagent R2 is an auxiliary reagent. In the detection of some target substances, the dry reagent R1 contains all the detection reagents, while the wet reagent R2 only contains the solvent (such as pure water and preservatives, and the preservatives combined with pure water have a bacteriostatic effect). Different analytes have different compositions of detection reagents and auxiliary reagents; as long as different components do not produce chemical reactions, try to include all detection reagents and auxiliary reagents in dry reagent R1, and wet reagent R2 only contains pure water (Some preservatives need to be added to have bacteriostatic effect); or, the wet reagent R2 may also contain some reagent components that have a longer shelf life and may chemically react with some components of the reagent R1. The standard is that the wet reagent R2 contains as few components as possible, until only pure water is used as a solvent; even if the wet reagent R2 also needs to contain reagent components, it is necessary to choose the reagent components that are easier to store under normal conditions.

Because reagent R1 is a dry reagent and is stored in a dry environment, coupled with the protection of sealing and various stabilizers, it can maintain excellent stability at room temperature, and the shelf life is much longer than that of wet reagents; It is a wet reagent, but does not contain any enzymes or other reagents that are unstable in aqueous solution for a long time, or perishable components. It only contains solvent. In the best case, reagent R2 only contains pure water. It can also be used at room temperature. have a longer shelf life. Therefore, both reagent R1 and reagent R2 have excellent stability and long shelf life, especially at room temperature, which provides convenience for use in household and POCT scenarios.

Preferably, the seal is a sealing membrane and/or a removable cover.

Preferably, the sealing member provided for the opening at the top of the storage detection container 1 (ie, the opening at the top of the second chamber 12 ) is the sealing film 13 and/or a removable cover. The opening at the top of the storage detection container 1 is set to be sealed by the sealing film 13 or the cover body, which can prevent impurities such as dust from entering and affect the properties and stability of the wet reagent R2, and can also ensure that the reagent does not leak during transportation and storage. It is sufficient to remove the cover or use external force to break the sealing film 13 at the opening; it is also possible to set the sealing film 13 and the cover at the same time, and to remove the cover first and then break the sealing film 13 during use.

Preferably, the storage detection container 1 is formed by assembling a first casing 14 and a second casing 15 , the first chamber 11 is located in the first casing 14 , and the second chamber 12 is located in the second casing The top of the first shell (14) and the bottom of the second shell (15) are respectively provided with sealing films (13).

As the first embodiment of the structure of the storage testing container 1, the storage testing container 1 is formed by assembling a first housing 14 and a second housing 15, the first chamber 11 is located in the first housing 14, and the second chamber 11 is located in the first housing 14. The chamber 12 is located within the second housing 15 .

When manufacturing, the steps are as follows:

The first shell 14 and the second shell 15 are processed and formed respectively, and the first chamber 11 and the second chamber 12 are naturally formed inside;

A sealing film 13 or a cover is provided at the opening at the top of the second housing 15 for use;

The dry reagent R1 is directly added into the first shell 14, and sterilization is optional; or, the prepared reagent R1 in liquid state is combined with the first shell 14 through a drying process such as vacuum drying to make the liquid Then the sealing film 13 is fixed with the first housing 14, and the sealing film 13 is the sealing film between the first chamber 11 and the second chamber 12, so that the dry reagent R1 is stored in the independent sealed space of the first cavity 11;

Invert the second housing 15, add the wet reagent R2 in the second chamber 12, and then assemble the above-mentioned first housing 14 upside down into the opening of the second housing 15 for assembly with the first housing 14, through The assembly between the first casing 14 and the second casing 15 realizes connection and sealing, that is, the storage detection container 1 is prepared.

The assembly between the first casing 14 and the second casing 15 can be a detachable threaded assembly structure, an annular concave-convex snap ring and a snap groove assembly structure, a block-shaped tab and a snap hole assembly structure, or The non-detachable connection between the first casing 14 and the second casing 15 can be made by means of heat fusion or the like.

When the first shell 14 and the second shell 15 are assembled, the diameter of the cavity wall of the first shell 14 may be larger than the diameter of the cavity wall of the second shell 15, and the second shell 15 is inserted into the first shell 14 for assembly. Can also be reversed.

The connection of the sealing film 13 to the housing can be achieved by a conventional heat-sealing film process or other conventional processes in the art.

The sealing film 13 can also be disposed at the opening of the second casing 15 for assembling with the first casing 14. Then, after the first casing 14 and the second casing 15 are assembled, there will be two layers of the sealing film 13 on the two sides. between. The effect of arranging the sealing film 13 at the opening of the second shell 15 for assembling with the first shell 14 first is that the second shell 15 can be assembled without turning the second shell 15 upside down. The body 15 is turned upside down, but the opening at the top of the second housing 15 is closed after adding the reagent.

Preferably, the storage detection container 1 is formed by assembling a main body casing 16 and a base 17 , the first chamber 11 and the second chamber 12 are both located in the main body casing 16 ; the base 17 and the main body casing 16 The bottom connects and seals the first chamber 11 .

As the second embodiment of the structure of the storage detection container 1, the storage detection container 1 is formed by assembling the main body casing 16 and the base 17, and the first chamber 11 and the second chamber 12 are both located in the main body casing 16; The bottom of the main body case 16 connects and seals the first chamber 11 .

The processing steps are as follows:

The main body shell 16 and the base 17 are processed and formed respectively;

If the sealing film 13 is arranged in the main body casing 16, the first chamber 11 and the second chamber 12 are formed in the main body casing 16;

The dry reagent R1 is directly added to the inner cavity of the base 17 or the main body housing 16 provided with the sealing film 13, optionally sterilized or not;

Connect the base 17 to the main body shell 16 to seal the first chamber 11;

The wet reagent R2 is added to the second chamber 12 of the main body casing 16 , and then a sealing film 13 and/or a cover is arranged on the main body casing 16 to seal the second chamber 12 .

Between the base 17 and the main body shell 16 can be a detachable threaded assembly structure, an annular concave-convex snap ring and a snap groove assembly structure, a block-shaped tab and a snap hole assembly structure, or by means of hot melt or the like. Achieve non-detachable connections.

Preferably, the main body shell 16 is provided with an inner convex step, the middle of the step is a through hole, and the sealing film 13 is fixed on the step, so that the processing of the sealing film 13 is more convenient; at the same time, the opening means that the quantitative sampler 2 breaks the seal Membrane channels through which reagents are mixed.

Preferably, at least two sides of the first chamber 11 are parallel, and the two parallel sides are made of light-transmitting material; or,

At least two adjacent side surfaces of the first chamber 11 are flat surfaces, and both adjacent two side surfaces are made of light-transmitting materials.

Preferably, at least two side surfaces of the first chamber 11 are parallel and made of light-transmitting material, or at least two adjacent side surfaces of the first chamber 11 are flat and made of light-transmitting material. When the sample is detected by detecting the absorbance, the two opposite sides of the first chamber 11 are set to be flat and parallel, and set to a light-transmitting material at the same time, which can ensure the accuracy of the detection result; and when detecting the excitation fluorescence, it can be relative The two sides are flat, or the two adjacent sides are flat. When detecting other indicators, the first chamber 11 can be set to different shapes or structures as required; thus, it is not necessary to pour the liquid into the cuvette for detection, which simplifies the operation.

At the same time, the light-transmitting material also ensures the accuracy of detection, and it is further preferred to use colorless and transparent materials.

A detection device, comprising a storage detection container 1 and a sampler, wherein the storage detection container 1 is the storage detection container described in any of the above;

The sampler can be inserted into the storage testing container 1 to pierce the sealing film 13 and inject the sample into the storage testing container 1 .

The present application also provides a detection device, comprising the above-mentioned storage detection container 1 and a sampler. The sampler is inserted into the storage detection container 1 to pierce the sealing film 13, and the sample is injected into the storage detection container 1, thereby destroying the sealing film 13. Mix the wet reagent R2 and the dry reagent R1 and react with the sample. The detection device provided in this application is not only suitable for the field of in vitro diagnosis, but also for other chemical analysis fields, with a wide range of applications, stable long-term storage performance, and easy operation. Simple and convenient.

When the opening sealing member at the top of the storage testing container (1) is a sealing film, the sampler can simultaneously pierce the sealing film of the top opening and the sealing film between the first chamber and the second chamber; When two layers of sealing films are arranged between the casing and the second casing, the sampler can also be punctured at the same time.

Preferably, the sampler is a quantitative sampler 2, and the quantitative sampler 2 includes a capillary 21, a reaming part 22 and a hand-held part 23, and both ends of the capillary 21 are in contact with the outside air; the reaming The part 22 is arranged around the outer periphery of the capillary tube 21, the capillary tube 21 and the reaming part 22 can extend into the storage and detection container 1 and pierce the sealing film 13; the hand-held part 23 is connected with the capillary tube 21 and/or the sealing film 12 connect.

It is further preferred that the sampler is a quantitative sampler 2, and the quantitative sampler 2 includes a capillary 21, a reaming member 22 and a hand-held portion 23. When in use, the capillary 21 of the quantitative sampler 2 is used to pierce the sealing membrane 13, so as to be located in the second chamber 12. The wet reagent R2 inside falls into the first chamber 11, and at the same time the sample sucked in the capillary 21 also enters the first chamber 11, then the two reagents and the sample are mixed in the first chamber 11, and the reagent and the sample occur. Then use the detector analyzer for detection to obtain the detection result; due to the quantitative volume and capillary action of the inner tube of the capillary, quantitative sampling can be achieved when collecting liquid samples, and the detection result is the result of quantitative analysis, which is more qualitative than qualitative analysis. More accurate and more applicable.

When using the quantitative sampler 2 provided in the present application for detection, the user only needs to operate the quantitative sampler 2. After the sampling is completed, insert the quantitative sampler 2 into the storage detection container 1 and insert it in place, and gently shake the storage detection container 1, that is, It can be placed on the analyzer for the final detection step, and the test results can be obtained for fast and easy analyte detection. And when the quantitative sampler 2 provided in the present application is pierced, not only the capillary 21 pierces the sealing membrane, but also the reaming member 22 pierces the sealing membrane at the same time, and the reaming member 22 will further break the sealing membrane 13, so that the second cavity is pierced. The wet reagent R2 in the chamber 12 enters the first chamber 11 as fully as possible, and the wet reagent R2 enters the first chamber 11 as soon as possible, and is mixed with the dry reagent R1 in a short time. For example, the wet reagent R2 is in the sample. Mixed with dry reagent R1 before to ensure accurate test results.

In the actual use process, after the quantitative sampler 2 is pierced, the wet reagent R2 first flows into the first chamber 11 to be mixed with the dry reagent R1. At this time, the sample in the capillary 21 may not flow out (or may flow down, but the probability is higher than that of the dry reagent R1). Shaking can also speed up the mixing of dry reagent R1 and wet reagent R2; when the sample also flows down and mixed, shaking can also speed up dry reagent R1, wet reagent R2 and the sample Mix faster. In this way, the wet reagent R2 can be mixed and reconstituted with the dry reagent R1 first, and then the sample can be mixed and reacted with the mixed reconstituted solution.

The quantitative sampler 2 also includes a hand-held part 23, and the operator can grasp the hand-held part 23, not only can the capillary 21 penetrate deep into the sample for sampling, but also can insert the capillary 21 and the reaming part 22 into the storage detection container 1 and pierce the sealing film 13, and it is convenient for the operator to provide the force to pierce the sealing film 13, which is simple and quick. The capillary 21 , the reaming part 22 and the hand-held part 23 of the quantitative sampler 2 can be integrally formed, or can be assembled and formed after being processed separately.

Both ends of the capillary tube 21 are in contact with the outside air, which can ensure that the capillary tube 21 can normally inhale the sample. The capillary 21 used in this application can quantitatively suck in a certain amount of various liquid samples, the samples can be capillary blood, venous blood, arterial blood, and various other body fluids; the sample volume can be 5-100 microliters, and the preferred volume is 10 µl.

Preferably, the reaming member 22 includes at least one reaming plate 221 , the lower portion of the reaming plate 221 is connected to the side wall of the capillary 21 , and the top of the reaming plate 221 is connected to the hand-held portion 23 .

Preferably, the reaming member 22 includes at least one reaming plate 221, and the lower part of the reaming plate 221 is connected to the side wall of the capillary tube 21, and the extension direction is the same as the axial direction of the capillary tube 21, which can not only enlarge the opening section of the sealing membrane 13, but also Play the role of strengthening the strength of the capillary 21 .

The hand-held part 23 can be connected with the capillary tube 21 and/or the reaming part 22. Here, preferably, the lower part of the reaming plate 221 is connected with the side wall of the capillary tube 21, and the top of the reaming plate 221 is connected with the hand-held part 23. 221 realizes the connection between the hand-held part 23 and the capillary 21 , which is easy to process, and can avoid the influence on the capillary 21 to absorb the sample.

When a plurality of reaming plates 221 are provided, the reaming plates 221 are distributed circumferentially around the capillary tube 21 , and the reaming plate 221 forms a structure similar to a rib on the outside of the capillary tube 21 . Preferably, the reaming plates 221 are evenly distributed around the circumference of the capillary 21 .

Preferably, the lower part of the reaming plate 221 is connected to the upper side of the side wall of the capillary 21, then the lower part of the capillary 21 is not connected to the reaming plate 221 in the circumferential direction. When sampling the capillary 21, it can be avoided that the residual sample on the reaming plate 221 leads to inaccurate quantification. At the same time, when both the capillary 21 and the reaming plate 221 break the sealing membrane 13, the capillary 21 will further extend into the first chamber 11 to ensure that the sample in the capillary 21 can be in contact with the reagent.

The handle portion 23 preferably includes a central handle post and a circle of protrusions around the periphery of the handle post. The recess between the handle post and the protrusion is for the operator's fingers to insert, which can be firmly grasped even when wearing gloves.

Preferably, the radial dimension of the reaming plate 221 gradually shrinks from the top to the bottom.

Preferably, the radial dimension of the reaming plate 221 gradually shrinks from the top to the bottom, which reduces resistance and is more conducive to expanding the opening on the sealing membrane 13 .

The storage detection container 1 provided in this application is preferably made of any one or more of plastic, glass, paper, metal, metal oxide or quartz materials; the quantitative sampler 2 is preferably made of any one of plastic and glass or more. Specifically, the plastic is any one of polyethylene, polypropylene, polyvinyl chloride, styrene, polyamide, polycarbonate, polyoxymethylene, polyphenylene ether, and polyester.

A glycosylated hemoglobin detection kit, using the detection device described in any one of the above to store reagents and add samples, wherein the dry reagent R1 stored in the first chamber 11 includes protease, hydrogen peroxide, fructose base peptide oxidase, hydrogen peroxide color reagent;

The wet reagent R2 stored in the second chamber 12 includes water, preservatives.

The present application also provides a glycated hemoglobin detection kit, the dry reagent R1 stored in the first chamber 11 includes protease (PRK), hydrogen peroxide, fructosyl peptide oxidase (FPOX), and hydrogen peroxide chromogenic reagent; Defoamers and stabilizers are preferably also included. The wet reagent R2 stored in the second chamber 12 includes water, preservatives; preferably surfactants and buffer solutions. The volume of the wet reagent R2 is between 10-2000 microliters, preferably the volume of the wet reagent R2 is 500 microliters; the function of the wet reagent R2 is for blood dilution, hemolysis, and a chemical reagent for dissolving the dry reagent R1.

The present application also provides a method for detection using a glycosylated hemoglobin detection kit. The user collects blood samples through a sampler, inserts the sampler into the storage detection container 1 and breaks the sealing film 13, so that the wet reagents R2, After the dry reagent R1 and the blood sample are mixed together, shake the storage test container 1 gently to mix the three evenly; due to the difference in osmotic pressure and the effect of the surfactant, the blood is immediately hemolyzed, and the reagent R1 is also dissolved, and the protease (PRK) Under the action of hemoglobin A1c, the N-terminus of the β chain of hemoglobin A1c is cut off and the glycated dipeptide is released, and fructosyl peptide oxidase (FPOX) acts on the glycated dipeptide to generate hydrogen peroxide; in the presence of peroxidase (POD), The hydrogen peroxide reacts with the developer to produce a color reaction. The reaction principle is as follows:

(1)

(2)

(3)

The above reactions (1)-(3) can be accelerated under the temperature control state of 37°C.

The concentration of the glycated moiety (GHb) of hemoglobin can be obtained by measuring the absorbance at 660 nm, and the concentration of hemoglobin (Hb) can be obtained by measuring the absorbance at 520 nm. According to the obtained GHb concentration and Hb concentration, the content of glycated hemoglobin HbA1c can be calculated:

(4)

The analyzer can use spectrophotometric test equipment, which can be desktop equipment, portable small equipment, or hand-held meters. The spectrophotometric test equipment has a temperature control function, which can maintain a stable temperature during the test process. The temperature control range can be 25℃-45℃. From the preferred angle, the temperature is controlled at 37±0.5℃. Spectrophotometric testing equipment has at least one light source capable of emitting light of at least two different wavelengths.

The intensity of the color developed or the absorbance at a specific wavelength is directly proportional to the glycated dipeptide. Commercially available various proteases, hydrogen peroxide and fructosyl peptide oxidase can be used. There are many commercially available hydrogen peroxide color-developing agents, which have different wavelengths of absorption from the color-developing products of hydrogen peroxide. The larger the difference between the absorption peaks, the better. In the present invention, light with wavelengths of 520 nm and 660 nm is preferred for the determination of hemoglobin (Hb) and the glycated fraction (GHb) in hemoglobin, respectively, and the ratio of GHb and Hb concentration is HbA1c (%). The wavelength range that can be selected for measuring Hb is very wide, but when Hb is measured at a wavelength of 520 nm, GHb has almost no light absorption and does not interfere with the measurement of Hb. For the same reason, the wavelength of 660 nm was chosen to measure GHb, which also avoided the interference of Hb. It is also worth emphasizing that, because in the same solution, using two different wavelengths to measure Hb and GHb at the same time can eliminate the interference of the background of the solution and the background of the test tube material to the greatest extent, so as to achieve the purpose of accurately measuring HbA1c, as shown in the figure. 12 shown.

The above description of the disclosed embodiments enables any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims (10)

1. A storage and assay container, characterized in that the top of the storage and assay container (1) is provided with an opening, a first chamber (11) for storing a dry reagent and a second chamber (12) for storing a wet reagent are formed in the storage and assay container (1),

the second chamber (12) is positioned above the first chamber (11), and the first chamber (11) and the second chamber (12) are separated by a sealing film (13);

the opening at the top of the storage detection container (1) is sealed by a sealing member.

2. A storage testing container according to claim 1 wherein the seal is a sealing membrane and/or a removable cover.

3. A storage testing container according to any of claims 1-2, characterized in that the storage testing container (1) is assembled from a first housing (14), a second housing (15), the first chamber (11) being located within the first housing (14), the second chamber (12) being located within the second housing (15); sealing films (13) are respectively arranged at the top of the first shell (14) and the bottom of the second shell (15).

4. A storage test receptacle according to any of claims 1-2, characterized in that the storage test receptacle (1) is formed by assembling a body housing (16) with a base (17), the first chamber (11) and the second chamber (12) being located in the body housing (16); the base (17) is connected with the bottom of the main body shell (16) and seals the first chamber (11).

5. A storage assay container according to any of claims 1-2, wherein the first chamber (11) is at least two parallel sided and the two parallel sides are made of a light transmissive material; or the like, or, alternatively,

at least two adjacent side surfaces of the first cavity (11) are planes, and the two adjacent side surfaces are made of light-transmitting materials.

6. A test device comprising a storage test receptacle (1) and a sampler, wherein the storage test receptacle (1) is a storage test receptacle according to any one of claims 1-5;

the sampler can extend into the storage detection container (1) to puncture the sealing film (13) and inject the sample into the storage detection container (1).

7. The detection apparatus according to claim 6, wherein the sampler is a quantitative sampler (2), the quantitative sampler (2) comprises a capillary tube (21), a hole-expanding member (22) and a hand-held portion (23), and both ends of the capillary tube (21) are in contact with the outside air; the pore-expanding component (22) is arranged around the periphery of the capillary tube (21), and the capillary tube (21) and the pore-expanding component (22) can extend into the storage detection container (1) and puncture the sealing membrane (13); the handle (23) is connected to the capillary (21) and/or the sealing membrane (12).

8. The detection device according to claim 7, wherein the reaming means (22) comprises at least one reaming plate (221), the lower part of the reaming plate (221) is connected with the side wall of the capillary tube (21), and the top part of the reaming plate (221) is connected with the hand-held part (23).

9. The detection device according to claim 8, characterized in that the radial dimension of the expanded well plate (221) is gradually reduced from top to bottom.

10. A glycated hemoglobin assay kit, storing reagents and loading them using the assay device according to any one of claims 6 to 9, wherein the dry reagent R1 stored in the first chamber (11) comprises protease, hydrogen peroxide oxidase, fructosyl peptide oxidase, hydrogen peroxide developer;

the wet reagent R2 stored in the second chamber (12) includes water, a preservative.

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