CN214427446U

CN214427446U - cTnI detection reagent strip and kit

Info

Publication number: CN214427446U
Application number: CN202120289795.8U
Authority: CN
Inventors: 张二盈; 唐劲松; 齐芳
Original assignee: Shenzhen Kingfocus Biomedical Engineering Co ltd
Current assignee: Shenzhen Kingfocus Biomedical Engineering Co ltd
Priority date: 2021-02-01
Filing date: 2021-02-01
Publication date: 2021-10-19
Anticipated expiration: 2031-02-01

Abstract

The utility model discloses a cTnI detection reagent strip, be provided with sample groove, a plurality of reagent groove and a plurality of reaction tank of a splendid attire sample on the reagent strip, it is a plurality of the reagent groove splendid attire respectively is wrapped by the cTnI antibody solution that has the magnetic particle mark, enzyme-labeled cTnI antibody solution, first washing liquid, second washing liquid and substrate liquid, enzyme-labeled cTnI antibody solution includes alkaline phosphatase, horseradish peroxidase or acridinium ester mark's cTnI antibody. Also discloses a kit.

Description

cTnI detection reagent strip and kit

Technical Field

The utility model relates to a biomedical detects the instrument, and more specifically relates to a cTnI detect reagent strip and kit.

Background

Cardiovascular diseases are major fatal diseases which harm the health and life of people in China, according to the statistics of Ministry of health, two hundred and thirty-five people die of cardiovascular and cerebrovascular diseases in every hundred thousand in cities in China, account for the first death caused by various diseases, and are increased by 2% every year. Acute Myocardial Infarction (AMI) is a main cause of death of cardiovascular patients, and AMI is a clinical paroxysmal disease, and the onset of AMI is often accompanied by a series of symptoms such as chest pain, nausea, fever, arrhythmia, serum marker rise and the like, and the AMI can be diagnosed as soon as possible and intervene in treatment, and has important significance for saving dying cardiac muscle, improving prognosis, reducing the death rate in Acute stage and the like.

Troponin (Tn) is a contraction regulation protein of cardiac and skeletal muscles, and cTn is cardiac troponin, which is composed of three subunits, cTnI, cTnT and cTnC. cTnI, cTnC and cTnT play an important regulation role in the muscle relaxation and contraction processes, but the cTnC has no myocardial specificity and is not generally used for detecting myocardial damage, and neither the cTnI nor the cTnT can penetrate cell membranes to enter blood under a normal state, so the cTnI and the cTnT in the blood of healthy people are extremely low, if myocardial cells are damaged, the cTnI and the cTnT can enter intercellular substances and the blood, but the content of the cTnT in the blood is also greatly improved in diseases such as renal failure, pneumonia, septicemia and the like, so the specificity for detecting AMI by the cTnT is low; and cTnI rises 3-5 hours after AMI is diseased, reaches a peak in 15-24 hours, lasts for a long time, and can be reduced to normal after 5-10 days, so that the cTnI is used for diagnosing myocardial infarction and myocardial cell injury at present, and is a new 'gold standard' for diagnosing AMI.

The most common detection method of cTnI in the market at present is a chemiluminescence method, which has high sensitivity, but most hospital detection instruments are large chemiluminescence instruments, which have high instrument cost and need regular maintenance and cleaning and are only suitable for large hospital clinical laboratories; and the corresponding kit has large loading capacity, so that the reagent can not be used up within the bottle opening validity period to cause waste, and the repeated bottle opening use can cause the volatilization of each component liquid of the reagent to cause inaccurate test results.

Disclosure of Invention

The utility model aims to solve the technical problem that a cTnI detection reagent strip and kit that sensitivity is higher and easy and simple to handle, with low costs are provided.

In order to solve the above technical problem, according to an aspect of the present invention, a cTnI detection reagent strip is provided, the reagent strip is provided with a sample tank capable of containing a sample, a plurality of reagent tanks and a plurality of reaction tanks, the reagent tanks are respectively filled with a cTnI antibody solution coated with a magnetic particle label, an enzyme-labeled cTnI antibody solution, a first cleaning solution, a second cleaning solution and a substrate solution, and the enzyme-labeled cTnI antibody solution includes an alkaline phosphatase, horseradish peroxidase or acridinium ester-labeled cTnI antibody.

The further technical scheme is as follows: the magnetic particles include particles having amino groups, carboxyl groups or p-toluenesulfonyl groups on the surface.

The further technical scheme is as follows: the cTnI antibody solution coated with the magnetic particle marker comprises a conjugate of a particle with a carboxyl group on the surface and a cTnI antibody.

The further technical scheme is as follows: the substrate solution comprises dioxane, a dioxane analogue, luminol or a luminol derivative.

The further technical scheme is as follows: the first cleaning solution comprises a buffer solution, a surfactant and a preservative.

The further technical scheme is as follows: the second cleaning solution comprises a buffer solution, a surfactant and a preservative.

In order to solve the technical problem, according to the utility model discloses an on the other hand provides a cTnI detect reagent box, and it includes the box body, place the calibrator and an at least reagent strip of a plurality of different concentrations in the box body, the reagent strip is foretell reagent strip.

The further technical scheme is as follows: the kit comprises 7 calibrators with different concentrations, wherein each calibrator comprises a cTnI antigen, and the concentrations of the cTnI antigens in the 7 calibrators are 0.0ng/mL, 0.25ng/mL, 0.50ng/mL, 2.50ng/mL, 10.0ng/mL, 50.0ng/mL and 100ng/mL respectively.

Compared with the prior art, the utility model discloses in adopt alkaline phosphatase, horse radish peroxidase or acridinium ester mark cTnI antibody, luminous efficacy and sensitivity are higher, and have strong stability, can improve and detect the accuracy, and be provided with the sample groove of splendid attire sample in every reagent strip, the reagent groove of the different reactant of splendid attire and be used for supplying the sample to carry out the reaction tank that reacts with the reagent, can accomplish a sample detection through a reagent strip, and easy operation exhausts the abandonment can, the cost is lower, and the volume is less, can avoid the big packing to use to cause the waste with incomplete, open the bottle repeatedly and use and cause the pollution scheduling problem.

Drawings

Fig. 1 is a schematic structural diagram of a specific embodiment of the cTnI test strip of the present invention.

Detailed Description

To make the objects, technical solutions and advantages of the present invention more clearly understood by those skilled in the art, the present invention will be further described with reference to the accompanying drawings and examples.

Referring to fig. 1, fig. 1 is a schematic structural diagram of a specific embodiment of a cTnI detection reagent strip 10 of the present invention. In the embodiment shown in the drawings, a sample tank 1 capable of containing a sample, a plurality of reagent tanks 2 and a plurality of reaction tanks 3 are arranged on the reagent strip 10, the plurality of reagent tanks 2 respectively contain a magnetic particle-coated cTnI antibody solution, an enzyme-labeled cTnI antibody solution, a first cleaning solution, a second cleaning solution and a substrate solution, and the enzyme-labeled cTnI antibody solution comprises alkaline phosphatase, horseradish peroxidase or acridinium ester-labeled cTnI antibody. The total number of the reagent grooves 2, the sample grooves 1 and the reaction grooves 3 in the utility model can be 12-18, in this embodiment, 14 are provided, the distribution of the reagent grooves 2, the sample grooves 1 and the reaction grooves 3 on the reagent strip 10 is shown in the figure, the sample grooves 1 are positioned on one side of the reagent strip 10, the reaction grooves 3 can be positioned on the other side of the reagent strip 10, and can also be positioned between the reagent grooves 2; understandably, the magnetic-particle-labeled cTnI antibody solution, the enzyme-labeled cTnI antibody solution, the first cleaning solution, the second cleaning solution, and the substrate solution may be placed in the reagent reservoir 2 at will. Based on above-mentioned design, adopt alkaline phosphatase, horseradish peroxidase or acridinium ester mark cTnI antibody, luminous efficacy is high, and can discern the trace antibody, have high sensitivity, characteristics such as strong stability, can improve and detect the accuracy, and be provided with the sample groove 1 of splendid attire sample in every reagent strip 10, the reagent groove 2 of the different reaction reagent of splendid attire and be used for supplying the sample to carry out the reaction tank 3 that reacts with the reagent, can accomplish a sample detection through a reagent strip 10, and easy operation, use up the abandonment can, the cost is lower, and the volume is less, can avoid the incomplete waste that causes of big packing, open the bottle repeatedly and use and cause the pollution scheduling problem.

In certain embodiments, the magnetic particles may be particles having any one of amino groups, carboxyl groups, or p-toluenesulfonyl groups on the surface thereof, which can be coupled to an antibody; preferred are microparticles having carboxyl groups on the surface of the microsphere. In this embodiment, the magnetic particle-labeled cTnI antibody solution includes a conjugate of a particle having a carboxyl group on the surface and a cTnI antibody.

In some embodiments, the substrate solution comprises dioxane, a dioxane analog, luminol, or a luminol derivative, preferably a dioxane analog; the first cleaning solution comprises a buffer solution, a surfactant and a preservative, the second cleaning solution and the first cleaning solution can be the same solution or different solutions, namely the proportions of the components in the first cleaning solution and the second cleaning solution can be different.

The utility model discloses the volume that sample groove 1 can deposit liquid in the cTnI test reagent strip 10 is 100 mu L, reagent groove 2 has two kinds of different capacity specifications, the volume that can deposit liquid is 100 mu L, another kind is 300 mu L, wherein the parcel has magnetic particle mark's cTnI antibody solution, enzyme mark's cTnI antibody solution can place in small-capacity reagent groove 2, first washing liquid, second washing liquid and substrate liquid can place in large-capacity reagent groove 2, and reaction tank 3 is the preparation container, can supply sample and reagent to react, it can deposit the volume of liquid is 300 mu L, in the time of using, at first react 50 mu L's sample to be measured and 50 mu L's parcel has magnetic particle mark's cTnI antibody solution and 50 mu L's enzyme mark's cTnI antibody solution for 5 minutes, carry out magnetic separation after the reaction, the complex that obtains after about to react is placed in first washing liquid and second washing liquid and is washd, after the cleaning, 200 mu L of substrate solution is added and mixed evenly, and a POCT luminometer or a full-automatic chemiluminescence meter can be used for reading a signal value to detect the luminous intensity within 5 minutes, so that the accuracy is high, the application range is wide, and great convenience is provided for clinical instant detection.

Understandably, the utility model also provides a cTnI detect reagent box, the kit includes the box body, place 7 calibrators and at least one reagent strip of different concentration in the box body, the reagent strip is the reagent strip of above-mentioned embodiment, and the calibrators is including cTnI antigen, preferably, 7 the concentration of cTnI antigen is 0.0ng/mL, 0.25ng/mL, 0.50ng/mL, 2.50ng/mL, 10.0ng/mL, 50.0ng/mL, 100ng/mL respectively in the calibrators.

To sum up, the utility model discloses in adopt alkaline phosphatase, horseradish peroxidase or acridinium ester mark cTnI antibody, luminous efficacy and sensitivity are higher, and have strong stability, can improve and detect the accuracy, and be provided with the sample groove of splendid attire sample in every reagent strip, the reagent groove of the different reactant of splendid attire and be used for supplying the sample to carry out the reaction tank that reacts with reagent, can accomplish a sample detection through a reagent strip, easy operation, it can to use up the abandonment, the cost is lower, and the volume is less, can avoid the big packing to use to cause the waste, open the bottle repeatedly and use and cause the pollution scheduling problem.

The foregoing is considered as illustrative of the preferred embodiments of the invention and is not intended to limit the invention in any way. Various equivalent changes and modifications can be made on the basis of the above embodiments by those skilled in the art, and all equivalent changes and modifications within the scope of the claims should fall within the protection scope of the present invention.

Claims

1. A cTnI detection reagent strip, which is characterized in that: the reagent strip is provided with a sample groove capable of containing a sample, a plurality of reagent grooves and a plurality of reaction grooves, the plurality of reagent grooves are respectively used for containing a magnetic particle-labeled cTnI antibody solution, an enzyme-labeled cTnI antibody solution, a first cleaning solution, a second cleaning solution and a substrate solution, and the enzyme-labeled cTnI antibody solution comprises alkaline phosphatase, horseradish peroxidase or acridinium ester-labeled cTnI antibody.

2. The cTnI detection reagent strip of claim 1, wherein: the magnetic particles include particles having amino groups, carboxyl groups or p-toluenesulfonyl groups on the surface.

3. The cTnI detection reagent strip of claim 1, wherein: the cTnI antibody solution coated with the magnetic particle marker comprises a conjugate of a particle with a carboxyl group on the surface and a cTnI antibody.

4. The cTnI detection reagent strip of claim 1, wherein: the substrate solution comprises dioxane, a dioxane analogue, luminol or a luminol derivative.

5. The cTnI detection reagent strip of claim 1, wherein: the first cleaning solution comprises a buffer solution, a surfactant and a preservative.

6. The cTnI detection reagent strip of claim 1, wherein: the second cleaning solution comprises a buffer solution, a surfactant and a preservative.

7. A cTnI detection kit is characterized in that: the kit comprises a kit body, wherein a plurality of calibrators with different concentrations and at least one reagent strip are placed in the kit body, and the reagent strip is the reagent strip in any one of claims 1-6.

8. The cTnI detection kit of claim 7, wherein: the kit comprises 7 calibrators with different concentrations, wherein each calibrator comprises a cTnI antigen, and the concentrations of the cTnI antigens in the 7 calibrators are 0.0ng/mL, 0.25ng/mL, 0.50ng/mL, 2.50ng/mL, 10.0ng/mL, 50.0ng/mL and 100ng/mL respectively.