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Preparation method of C reactive protein quality control substance used for POCT

A technology of reactive protein and control products, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of shortening the quality control test cycle of POCT, POCT instruments without supporting quality control products, etc., and achieve the effect of shortening the test cycle

Inactive Publication Date: 2017-12-22
嘉兴博泰生物科技发展有限公司
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Problems solved by technology

[0006] Aiming at the state of the prior art, the present invention provides a method for preparing a C-reactive protein quality control product for POCT, which significantly shortens the verification cycle of POCT quality control and solves the defect that POCT instruments have no matching quality control products

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  • Preparation method of C reactive protein quality control substance used for POCT
  • Preparation method of C reactive protein quality control substance used for POCT
  • Preparation method of C reactive protein quality control substance used for POCT

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Embodiment Construction

[0013] The present invention discloses a method for preparing a C-reactive protein quality control product for POCT. The specific embodiments of the present invention will be further described below with reference to the preferred embodiments.

[0014] A preparation method of a C-reactive protein quality control product for POCT according to the present invention, the preparation method comprises the following steps:

[0015] Step 1: The starting material is derived from commercially available sterile-filtered horse serum. After adding preservatives to the horse serum, centrifuge at 9000 rpm for 30 min at 4°C, take the supernatant, and filter it with double-layer qualitative fast filter paper. Lipid substances, and then pass through 0.45μm or 0.22μm hydrophilic membrane aseptic filtration in turn to form matrix substances;

[0016] Step 2: According to the concentration of the C-reactive protein mother solution and the recovery rate of addition, add C-reactive protein to the m...

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Abstract

The invention discloses a preparation method of a C reactive protein quality control substance used for POCT. The preparation method includes the steps of: 1) preparation of a substrate material: employing commercially available and sterile-filtered healthy horse serum as an initial raw material, adding a preservative, and performing granule removal, fat removal and sterile filtration to form the substrate material; 2) preparation of the quality control substance: adding human-sourced C reactive protein to the substrate material until target concentration 7-9 mg / L, and moving the quality control substance into cleaned and dried cryopreservation tubes by the volume of 1 ml in each tube, and performing liquid preservation at 2-8 DEG C to form a homogeneous and stable C reactive protein quality control substance, of which the concentration level is 7-9 mg per liter of horse serum substrate. The C reactive protein quality control substance has excellent uniformity and stability, and satisfies the demands in "Guiding Principle of Researching Techniques of In-vitro Diagnosis Reagent Calibration Substances and Quality Control Substances". The C reactive protein quality control substance is prepared from horse serum which has wide sources. The preparation method is simple.

Description

technical field [0001] The invention relates to a preparation method of a C-reactive protein quality control product, in particular to a preparation method of a C-reactive protein quality control product for POCT. Background technique [0002] 1. Clinical significance of C-reactive protein [0003] The full name of myocardial markers is the early markers of myocardial injury, which refer to markers whose blood levels increase within 6 hours after myocardial injury. Hypersensitive C-reactive protein (hs-CRP) is a series of inflammatory markers of acute coronary syndrome (ACS), which is mainly used for screening risk factors of coronary heart disease. [0004] 2. Research background of POCT quality control products [0005] Point of care testing (POCT) refers to a type of method that samples and analyzes at the patient's side to obtain diagnostic results quickly. The detection of myocardial markers in this way can rapidly diagnose myocardial infarction and heart failure, wh...

Claims

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Application Information

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IPC IPC(8): G01N33/533
CPCG01N33/533
Inventor 李海龙孟凡国薄哲程贝
Owner 嘉兴博泰生物科技发展有限公司