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Pet D-dimer detecting kit for micro chemiluminescence immune assay system

A technology of chemiluminescence immunoassay and detection kit, which is applied in the field of immunoassay to avoid non-specific reactions and ensure stability

Pending Publication Date: 2019-03-08
CHENGDU POLYTECH BIOLOGICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] There are discrepancies between the test results of different POCT methods currently on the market and similar methods applied to large-scale instruments. Therefore, it is necessary to further improve the method of domestic POCT reagents to improve their sensitivity. A method that is comparable to the test results of large-scale analyzers in the laboratory should be provided. Maintain a consistent POCT detection system to reduce unnecessary misdiagnosis and missed diagnosis

Method used

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  • Pet D-dimer detecting kit for micro chemiluminescence immune assay system

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0072] A pet D-dimer detection kit for a miniature chemiluminescent immunoassay system, characterized in that: D-dimer calibrator, enzyme conjugate working solution, capillary coated with D-dimer antibody , cleaning solution and chemiluminescence substrate.

[0073] Preparation of D-dimer calibrator:

[0074] The D-dimer calibrator is prepared from calibrator diluent and D-dimer. The D-dimer calibrator has six grades, and the concentrations of the six grades are: 0.01, 0.08, 0.25, 0.74, 2.22, 6.67μg / mL.

[0075] Described calibrator diluent comprises following composition:

[0076] Trishydroxymethylaminomethane 20mmol / L

[0077] NaCl 150mmol / L

[0078] Bovine serum albumin (mass percentage) 1%

[0079] Trehalose (mass percentage) 2%

[0080] Triton (volume percentage) 0.05%

[0081] Proclin300 (volume percentage) 0.05%.

[0082] The pH of the calibrator dilution is 7.0.

[0083] Preparation of enzyme working solution:

[0084] The concentration of the enzyme conjugat...

Embodiment 2

[0119] This embodiment is basically the same as Embodiment 1, the difference is:

[0120] The concentrations of the D-dimer calibrator were: 0.02, 0.1, 0.3, 0.8, 3, 8 μg / mL, respectively.

[0121] Described calibrator diluent comprises following composition:

[0122] Trishydroxymethylaminomethane 50mmol / L

[0123] NaCl 300mmol / L

[0124] Bovine serum albumin (mass percentage) 1%

[0125] Trehalose (mass percentage) 2%

[0126] Triton (volume percentage) 0.05%

[0127] Proclin300 (volume percentage) 0.05%.

[0128] The pH of the calibrator dilution is 7.2.

[0129] The concentration of the enzyme conjugate working solution was 0.8 μg / mL.

[0130] The enzyme conjugate dilution includes the following components: 50 mmol / L of trishydroxymethylaminomethane, 150-300 mmol / L of NaCl (mass percentage), 1% casein (mass percentage), 1% sucrose (mass percentage), glycerin (mass percentage) 1%, Tween 20 (volume percentage) 0.1%, ZnCl 2 (volume percentage) 0.05~5mmol / L, MgCl 2 (vo...

Embodiment 3

[0143] This embodiment is basically the same as Embodiment 1, the difference is:

[0144] The D-dimer calibrator is prepared from calibrator diluent and D-dimer, and the concentrations of the D-dimer calibrator are: 0.06, 0.18, 0.56, 1.67, 5.00, 15.00 μg / mL.

[0145] Described calibrator diluent comprises following composition:

[0146] Trishydroxymethylaminomethane 25mmol / L, NaCl 200mmol / L, bovine serum albumin (mass percentage) 1%, trehalose (mass percentage) 2%, Triton (volume percentage) 0.05%, Proclin300 (volume percentage) 0.05-0.2%.

[0147] The pH of the calibrator dilution is 7.3.

[0148] The concentration of the enzyme conjugate working solution was 1.5 μg / mL.

[0149] The enzyme conjugate working solution is prepared by adding enzyme conjugate diluent to the enzyme conjugate solution, wherein the enzyme conjugate diluent includes the following components:

[0150] Trishydroxymethylaminomethane 30mmol / L, NaCl (mass percentage) 250mmol / L, casein (mass percentage...

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Abstract

The inventio discloses a pet D-dimer detecting kit for a micro chemiluminescence immune assay system. The pet D-dimer detecting kit for the micro chemiluminescence immune assay system comprises D-dimer calibration products, enzyme conjugate working solution, D-dimer antibody-coated capillary tubes, cleaning solution and chemiluminescence substrates. The pet D-dimer detecting kit for the micro chemiluminescence immune assay system is high in sensitivity and specificity, wide in linear range, low in sample loading quantity, low in capacity of required plasma or serum samples and simple in operation method; only through simple operations such as manual adding of a small quantity of samples, users can achieve the aim of rapid and highly accurate pet disease diagnosis.

Description

technical field [0001] The invention belongs to the technical field of immune analysis, in particular to a pet D-dimer detection kit. Background technique [0002] Fibrin is the main component of thrombus. Its generation causes the activation of the fibrinolytic system, leading to the generation of plasmin and the dissolution of fibrin. The dissolution of cross-linked fibrin produces a series of specific degradation products, including D-dimer (D-dimer). The appearance of D-dimer marks the formation of stable fibrin, which also confirms that the fibrinolytic system is activated. The D-dimer monoclonal antibody used can recognize the antigenic determinants that fibrinogen and its degradation products do not have, so that the D-dimer content in plasma can be directly measured. [0003] D-dimer is a specific degradation product of cross-linked fibrin (Fb) after the action of plasmin, which can be used as a molecular marker of hypercoagulability and hyperfibrinolysis in vivo,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/552
CPCG01N33/552
Inventor 高礼珍冉鹏
Owner CHENGDU POLYTECH BIOLOGICAL TECH CO LTD
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