D-dimer buffer reagent with sample diluent function

A technology of buffer reagents and dimers, applied in the field of D-dimer buffer reagents, can solve the factors that affect the reaction environment, test speed interference, increase the difficulty and complexity of consumers' use, and affect the accuracy and reliability of results, etc. Problems, to achieve the effect that is conducive to marketing and customer use, strong achievability, and easy operation

Inactive Publication Date: 2022-07-12
SHENZHEN DYMIND BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, diluents are often not included in the manufacturer’s kits, so hospitals or customers need to purchase additional diluents or prepare diluents separately, which greatly increases the difficulty and complexity of consumers’ use.
At the same time, because it is not included in the kit, it is impossible to make a correct judgment on the diluent used by the client. Whether the diluent is suitable will directly affect the accuracy and reliability of the results.
In addition, the diluent will inevitably affect the reaction environment, test speed and bring new interference factors in the process of diluting the sample.

Method used

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  • D-dimer buffer reagent with sample diluent function
  • D-dimer buffer reagent with sample diluent function
  • D-dimer buffer reagent with sample diluent function

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] A D-dimer buffer reagent with the function of sample diluent, with the total volume of the reagent being 1L, it includes the following components: HEPES buffer solution with a content of 50mmol, 40g polyethylene glycol 6000, 0.05g mouse IgG , 4.5g sodium chloride, 65g bovine serum albumin, 0.6g EDTA, 0.3mL ProClin300, adjust the pH value of the buffer reagent to 7.5.

[0033] The above reagents were prepared as follows:

[0034] Prepare 50mmol of HEPES buffer, mix 40g polyethylene glycol 6000, 0.05g mouse IgG, 4.5g sodium chloride, 65g bovine serum albumin, 0.6g EDTA, 0.3mL ProClin300 with HEPES buffer, and make the total The volume was 1 L and the pH was determined to be 7.5.

[0035] The following examples were prepared in the same way.

[0036] In the present invention, through Example 1, on the basis of the basic buffer, coagulant, blocking agent, alkali metal chloride, inert protein, metal ion chelate, etc. are added, and corresponding performance tests are carried...

Embodiment 2

[0060] A D-dimer buffer reagent with the function of sample diluent, with the total volume of the reagent being 1L, it includes the following components: HEPES buffer solution with a content of 50mmol, 100g polyethylene glycol 6000, 0.1g mouse IgG , 5g sodium chloride, 65g bovine serum albumin, 0.6g EDTA, 0.3mL ProClin300, adjust the pH value of the buffer reagent to 7.5. After six-fold, eight-fold, and ten-fold dilution, the relative deviations of the sample concentration before dilution and the back-calculated concentration after dilution were 3.56%, 8.39%, and 9.77%, respectively.

Embodiment 3

[0062] A D-dimer buffer reagent with the function of sample diluent, with the total volume of the reagent being 1L, it includes the following components: HEPES buffer solution with a content of 50mmol, 20g polyethylene glycol 6000, 0.02g mouse IgG , 2g sodium chloride, 65g bovine serum albumin, 0.6g EDTA, 0.45mL ProClin300, adjust the pH value of the buffer reagent to 7.5. After six-fold, eight-fold, and ten-fold dilution, the relative deviations of the sample concentration before dilution and the back-calculated concentration after dilution were 4.12%, 7.21%, and 9.59%, respectively.

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Abstract

The invention discloses a D-dimer buffer reagent with a sample diluent effect, which is prepared from the following components by taking the total volume of the reagent as 1 L: 10 to 100 mmol of basic buffer solution, 30 to 100 g of coagulant, 0.02 to 0.1 g of blocking agent, 2 to 5 g of alkali chloride, 30 to 90 g of inert protein, 0.5 to 0.8 g of metal ion chelate and 0.3 to 0.8 mL of preservative, and the pH (Potential of Hydrogen) value of the D-dimer buffer reagent is 6.0 to 8.0. On the basis of a buffer function, the kit also has the effect of a sample diluent, does not need an additional sample diluent, can ensure the accuracy and reliability of a test result of a client, does not need to worry about the influence and interference of the sample diluent on the test result, and can eliminate the interference caused by a heterophile antibody in a test sample; compared with the prior art, operation is easy and convenient, realizability is high, and market popularization and customer use are facilitated.

Description

technical field [0001] The invention relates to the technical field of medical in vitro diagnosis, in particular to a D-dimer buffer reagent with the function of a sample diluent. Background technique [0002] The human fibrinolytic system plays a vital role in maintaining the normal permeability of blood vessel walls, maintaining blood flow and tissue repair. D-dimer is a specific degradation product produced by the hydrolysis of cross-linked fibrin by plasmin. Therefore, the changes of D-dimer can reflect the process of coagulation and fibrinolysis. When the level increases, it indicates that there is a frequent fibrin degradation process in the body, which is common in secondary hyperfibrinolysis, such as hypercoagulable state, disseminated intravascular coagulation, Kidney disease, organ transplant rejection, and more. Therefore, in theory, quantitative detection of D-dimer is a key indicator of deep vein thrombosis (DVT), pulmonary embolism (PE), disseminated intravas...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68G01N33/53
CPCG01N33/6893G01N33/5306G01N2333/78G01N2800/224
Inventor 陈志宇
Owner SHENZHEN DYMIND BIOTECH
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