Cardiac marker quality control serum preparation method

A quality control substance and substance technology, which is applied in the field of the preparation of myocardial marker substance control substances, can solve the problems such as the unoptimistic current situation of myocardial marker quality control, the inability of product performance to meet clinical requirements, the unstable structure of myocardial markers, and the like. The effect of promotion and development, good clinical practicability, and complete quality control testing items

Inactive Publication Date: 2019-06-21
郑州标源生物科技有限公司
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  • Abstract
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  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the unstable structure of most myocardial markers, there is still a lack of unified standards, which may lead to inconsistent adverse consequences in the test results obtained by using different detection methods or detection products from different manufacturers.
At present, the detection kits produced by most manufacturers do not contain quality control products, and the preparation of quality control products by clinical laboratories is affected by many factors. Therefore, the quality control status of myocardial marker detection in clinical laboratory departments is not optimistic. improve
Individual myocardial markers (such as: BNP, NT-proBNP, cTnI) are susceptible to interference from various enzymes in the serum due to the particularity of the antigen structure, and the stability is not good, so that the product performance cannot meet the clinical requirements; Some myocardial marker substances on the Internet use non-human serum matrix, which is significantly different from the matrix of clinical samples, which may easily cause inconsistent detection trends between quality control substances and clinical samples, causing matrix effects

Method used

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  • Cardiac marker quality control serum preparation method
  • Cardiac marker quality control serum preparation method
  • Cardiac marker quality control serum preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Example 1 Preparation of high, medium and low levels of myocardial marker substance control products

[0020] The first step is to take 1000ml of serum raw material, which comes from commercial normal human serum or hormone-free serum or lipid-free human serum, and the following indicators are negative after testing: HBsAg, HCV-Ab, HIV-Ab, TP ;

[0021] Reconstitute the serum and return it to room temperature, then bathe in water at 40-60°C for 1-3 hours; after returning to normal temperature, the serum background test results should meet the following requirements: CK<200U / L, CK-MB quality<0.6ng / ml, CK-MB activity<25U / L, MYO<45 ng / ml, cTnI<0.3ng / ml, cTnT<0.2ug / L, BNP<100pg / ml, NT-proBNP<300pg / ml, CRP<0.5mg / L , H-FABP<5ng / ml, HCY<15μmol / L, Dig<0.2ng / ml;

[0022] In the second step, the serum after the first water bath is removed by a filter membrane with a pore size of 0.22 μm-0.65 μm to obtain a quality control matrix solution;

[0023] The third step is to add posi...

Embodiment 2

[0026] The performance measurement of the quality control product prepared in embodiment 2 embodiment 1

[0027] 1. Detection value

[0028] Use the corresponding kit to detect each level of the quality control product on the claimed detection system, and the results are shown in Table 1 below.

[0029] Table 1

[0030]

[0031]

[0032] The data in Table 1 show that the above results are all within the given range. It proves that the detection results of each detection system are consistent.

[0033] 2. Uniformity

[0034] Take 10 bottles of quality control products of each level with the same batch number, test each bottle of quality control products once with the corresponding kit, and calculate the average value of the 10 test results ( ) and standard deviation S 1 ;

[0035] In addition, use 1 bottle of the above-mentioned 10 bottles of quality control products for 10 consecutive tests, and calculate the average value of 10 test results ( ) and standard dev...

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Abstract

The invention discloses a cardiac marker quality control serum preparation method. Normal human serum is adopted as a substrate liquid, impurities are removed by a filter membrane after a warm bath for 1 to 3 hours, CK, CK-MB, cTnI, cTnT, CRP, BNP, MYO, NT-proBNP, HCY, H-FABP, Dig and other cardiac marker positive substances are added to the obtained quality control serum substrate liquid, qualitycontrol serum solutions with a high, a medium and a low concentration level are prepared, a proper amount of preservative, a protein protective agent and a stabilizer are added and are then mixed uniformly, debugging and determining are carried out, and after the detected result meets a quality standard, the solution is placed in a glass bottle for low temperature vacuum drying to be in a freeze-dried state and is saved at 2 to 8 DEH C. The quality control serum selects normal human serum / normal human plasma / de-hormone human serum / delipidated human serum as the substrate liquid, and the stable-performance multi-item cardiac marker quality control serum prepared according to actual clinical demands has low viscosity, quick redissolving, little substrate effects, excellent clinical applicability, thereby greatly facilitating clinical promotion and development.

Description

technical field [0001] The invention relates to biological product technology, in particular to a method for preparing a cardiac marker substance control product. Background technique [0002] Myocardial markers are currently routine testing items in clinical laboratories. Due to the unstable structure of most myocardial markers, there is still a lack of unified standards, which may lead to inconsistent adverse consequences in the test results obtained by using different detection methods or detection products from different manufacturers. At present, the detection kits produced by most manufacturers do not contain quality control products, and the preparation of quality control products by clinical laboratories is affected by many factors. Therefore, the quality control status of myocardial marker detection in clinical laboratory departments is not optimistic. improve. Individual myocardial markers (such as: BNP, NT-proBNP, cTnI) are susceptible to interference from vario...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N1/28
Inventor 祖均丽刘俊英张举王新明刘功成
Owner 郑州标源生物科技有限公司
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