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
CN109916682AInactive Publication Date: 2019-06-21郑州标源生物科技有限公司
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
郑州标源生物科技有限公司
Publication Date
2019-06-21
Estimated Expiration
Not applicable · inactive patent

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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.
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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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