Cardiac troponin I magnetic particle chemiluminescence assay kit and usage method thereof

A cardiac troponin and chemiluminescence detection technology, applied in the field of troponin assay kits, can solve the problems of insufficient sensitivity and anti-interference ability, low degree of automation, low sensitivity, etc., so as to improve detection safety and accuracy, High detection sensitivity and specificity, reducing the effect of manual operations

Pending Publication Date: 2018-02-09
SUZHOU SYM BIO LIFESCI CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Among them, although the ELISA method has been used clinically for nearly two decades, it still has some fatal shortcomings, such as poor quantitative accuracy, long operation time, and low degree of automation; the colloidal gold method is flexible and easy to operate, but its sensitivity is low and its specificity is low. Poor; In addition, the myoglobin assay kit represented by radioimmunity in the past was limited by methodology, its sensitivity and anti-interference ability were seriously insufficient, and there were great disadvantages in polluting the environment, so it has basically withdrawn from the market
The chemiluminescence method has high sensitivity and good specificity, but the general chemiluminescence machine has a complicated liquid cleaning system, and the machine is generally relatively large. Even if it is made smaller by optimizing the design, it also makes the daily maintenance of the machine difficult.

Method used

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  • Cardiac troponin I magnetic particle chemiluminescence assay kit and usage method thereof
  • Cardiac troponin I magnetic particle chemiluminescence assay kit and usage method thereof
  • Cardiac troponin I magnetic particle chemiluminescence assay kit and usage method thereof

Examples

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Effect test

Embodiment 1

[0045]This embodiment provides a cardiac troponin I magnetic particle chemiluminescence detection kit, which includes a reagent strip consisting of several wells arranged side by side. The reagents contained in the reagent strip include cTnI magnetic particle reagent, cTnI labeled reactant, sample The diluent, calibrator, magnetic bead cleaning solution, and pre-excitation solution, each reagent is sealed and stored in the corresponding hole using heat-sealing film technology, which effectively prevents the reagent from crossing holes and solves the transportation problem.

[0046] On the magnetic particle chemiluminescence detection kit, a magnetic rod cover for use with a special up-suction magnetic bead transfer gun is provided in a hole on the kit, and the kit is used to detect cardiac troponin When detecting magnetic particle chemiluminescence, use the up-suction magnetic bead transfer gun to transfer the magnetic beads, and insert the magnetic rod deep into the liquid to ...

Embodiment 2

[0050] This embodiment provides a preparation method of the magnetic particle chemiluminescence detection kit, which specifically includes the following steps:

[0051] (1) Preparation of Cardiac Troponin I Calibrator

[0052] The cardiac troponin I antigen was prepared into a calibrator solution with 2% BSA and freeze-dried, and the enterprise standard product was used for assignment, and the concentrations were 0.2 and 10 ng / mL;

[0053] (2) Preparation of biotin-labeled cardiac troponin I antibody

[0054] Take 1 mg of cardiac troponin I antibody and dialyze with PB buffer (pH 8.1) at 4°C or room temperature for no less than 16-24 hours; add 0.05 mg of biotin to the dialyzed antibody, and then add PB buffer (pH 8.1) Make the final antibody concentration 1mg / mL, mix for 5min; place the mixture in a constant temperature incubator at 25±1°C, and let it stand for 120±10min to react. Use PB buffer (pH 7.4) to dialyze the biotinylated antibody at 4°C or room temperature for 16-...

Embodiment 3

[0074] This embodiment provides a method for using the cardiac troponin I magnetic particle chemiluminescence detection kit. During specific detection, the reagent strip 4 is placed in the incubation chamber 3, and the incubation chamber 3 is arranged on the conveyor belt. 2, the conveyor belt 2 is connected to the horizontal displacement motor 1, and the end of the conveyor belt 2 is provided with an analysis reading module 13; and an up-suction magnetic bead transfer gun that can move up and down relative to the magnetic rod cover 5 is used to realize the magnetization on the reagent strip. Rod cover, suction magnetic beads, magnetic bead elution, magnetic bead mixing, magnetic rod cover removal action;

[0075] Specifically include the following steps:

[0076] Step 1, take out the reagents, and place them in room temperature environment away from light as required. The reagent strips should be kept in an opaque aluminum foil bag. If you need to take them out, it is recomme...

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Abstract

The invention discloses a cardiac troponin I magnetic particle chemiluminescence assay kit and a usage method thereof. The kit includes a plurality of reagent strips composed of a plurality of side-by-side hole sites. The reagent strip includes a cTnI magnetic microparticle reagent and a cTnI labeled reagent and further includes a sample diluent, a calibration product, a magnetic bead cleaning solution and a pre-exciting solution. A magnetic rod sleeve is arranged in one hole site on the reagent strip. By combination of a chemiluminescence technology and immunomagnetic particles, the cardiac troponin I magnetic particle chemiluminescence assay kit has higher detection sensitivity and specificity and better performance parameters; the flexibility is high; different tests can be performed simultaneously, a single test can also be carried out, so that shorter test time can be obtained, and the product cost is greatly reduced.

Description

technical field [0001] The invention relates to a troponin assay kit, in particular to a cardiac troponin I assay magnetic particle chemiluminescence kit and a use method thereof. Background technique [0002] Cardiac Troponin I (cTnI) is a specialized contractile protein on cardiac muscle fibers, with a molecular weight of about 24KD. It is one of the three subunits of troponin (I, T, C), and tropomyosin Combined with actin through myofibril myofilaments. Its biological function is to inhibit the activity of actin-myosin ATPase and prevent the movement of myosin in the absence of calcium ions. Generally, it exists in cardiomyocytes in the form of cTnI-C-T complex and free cTnI. When cardiomyocytes are damaged by ischemia, free cTn is rapidly released into the blood through the cell membrane, and a low peak appears. When persistent or irreversible When injured, cardiomyocytes are necrotic and myofilaments are degraded, causing the release of bound cTn. The second peak appe...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68
CPCG01N33/6887
Inventor 颜克亮胡星海
Owner SUZHOU SYM BIO LIFESCI CO LTD
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