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Creatine kinase isoenzyme (CK-MB) detection kit capable of resisting heparin interference

A detection kit, creatine kinase technology, which can be used in measurement devices, instruments, scientific instruments, etc., can solve the problem of high measurement results

Pending Publication Date: 2021-02-19
SHANGHAI KEHUA BIO ENG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The existing creatine kinase isoenzyme (CK-MB) assay kit has the following defects: when a heparin tube is used as an anticoagulant tube, the measured result of the collected plasma is higher than that of the serum tube under the same conditions.

Method used

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  • Creatine kinase isoenzyme (CK-MB) detection kit capable of resisting heparin interference
  • Creatine kinase isoenzyme (CK-MB) detection kit capable of resisting heparin interference
  • Creatine kinase isoenzyme (CK-MB) detection kit capable of resisting heparin interference

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] The kit of the present invention comprises R1 reagent and R2 reagent, and described R1 reagent comprises: Magnesium acetate, polyethyleneimine (PEI), PGE, succinic acid, glucose, EDTA, AMP, ADP, NAD, 5-diadenosine phosphate , N-acetylcysteine, hexokinase, glucose-6-phosphate dehydrogenase and anti-CK-MB antibody, the R2 reagent includes: phosphocreatine.

[0036] The concentration of each substance in the R1 reagent is as follows:

[0037]

[0038] The concentration of each substance in the R2 reagent is as follows:

[0039] Imidazole buffer 63.5mmol / L

[0040] Phosphocreatine 4.3g / L

[0041] Parabens 13%.

[0042] The volume ratio of R1 reagent to R2 reagent is 3:1.

Embodiment 2

[0044] The steps of using the kit of Example 1 of the present invention to detect creatinine in a sample are as follows:

[0045] In the detection process, take the automatic Hitachi biochemical analyzer 7100 as an example. The main wavelength is 340nm (or near); the secondary wavelength is 410nm (or near); the light path of the cuvette is 1.0cm; the two-point velocity method; the rising reaction.

[0046] See Table 2 for reagent addition ratio:

[0047] Table 2 Reagent loading ratio

[0048]

[0049] The default unit of this kit is: U / L.

[0050] Calibration curve drawing: using Linear 2-point calibration curve calibration method. The value of the blank sample is 0.00 μmol / L, and the corresponding △A is measured for the calibrator, with △A as the Y axis and the concentration as the X axis. On the automatic analyzer, use Linear 2 points to establish the calibration curve. When calculating, find the corresponding concentration on the calibration curve according to the △...

Embodiment 3

[0054] In order to verify the probability of false positive detection between the invented kit and the commercially available creatine kinase assay kit, the best method is to use a third-party kit for verification, and the selected third-party kit is the Roche creatine kinase assay reagent box.

[0055] Among them, the three kits are: commercially available creatine kinase assay kit (kit I) without PEI, Roche creatine kinase kit (kit II) and the creatine kinase kit added in this embodiment. (Kit III). The reference range of the Roche creatine kinase kit is <25U / L, the reference range of the commercially available creatine kinase kit is <25U / L, and the reference range of the kit in this embodiment is <25U / L.

[0056] Source of specimens: 50 males with routine physical examination were selected as the research subjects. 5ml of venous blood was collected under fasting state and added to heparin anticoagulant blood vessels. The samples were centrifuged at low temperature for 5 mi...

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Abstract

The invention belongs to the technical field of creatine kinase isoenzyme (CK-MB) biochemical diagnosis, and discloses a creatine kinase isoenzyme (CK-MB) detection kit and a creatine kinase isoenzyme(CK-MB) detection method for resisting heparin interference. The detection kit comprises an R1 reagent and an R2 reagent, the R1 reagent comprises PEI or hydrophilic macromolecule modified PEI, and interference caused by heparin contained in a sample can be eliminated. Through test detection, compared with a serum tube, a heparin anticoagulant tube determination result is not too high and is consistent with a serum tube result by adding amine modified by a modification group into the reagent, so that the accuracy of the creatine kinase isoenzyme (CK-MB) detection kit is improved, and the stability of the kit is improved.

Description

technical field [0001] The invention belongs to the technical field of creatine kinase isoenzyme CK-MB biochemical detection, and relates to a heparin-resistant creatine kinase isoenzyme CK-MB detection kit. Background technique [0002] The creatine kinase isoenzyme CK-MB is mainly distributed in the myocardium. After the onset of acute myocardial infarction with chest pain, the serum CK-MB level increases. Serum CK-MB is an important indicator for diagnosing acute myocardial infarction and determining whether there is myocardial necrosis. Especially for acute myocardial infarction and recurrent myocardial infarction without Q wave in the electrocardiogram, the increase of serum CK-MB is decisive. The role of diagnosis. [0003] The creatine kinase isoenzyme (CKMB) assay kit is a relatively mature routine item on the market and registered by most IVD manufacturers. The existing creatine kinase isoenzyme (CK-MB) assay kit has the following defects: when a heparin tube is u...

Claims

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Application Information

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IPC IPC(8): G01N33/573
CPCG01N33/573G01N2333/9123
Inventor 沈宇杰
Owner SHANGHAI KEHUA BIO ENG
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