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Quality Control Substance for Blood Lipid Test

A quality control and substance technology, applied in the field of clinical testing, can solve the problems of reducing the stability of quality control substances, reducing stable and preservative components, and unfavorable laboratory quality control.

Active Publication Date: 2019-02-15
BEIJING STRONG BIOTECH INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This is not good for the quality control of the laboratory
However, reducing the introduction of stabilizing and preservative components will reduce the stability of the quality control material

Method used

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  • Quality Control Substance for Blood Lipid Test
  • Quality Control Substance for Blood Lipid Test
  • Quality Control Substance for Blood Lipid Test

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Embodiment 1. The preparation method of quality control substance

[0053] 1. Source and Processing of Serum Matrix

[0054] The serum matrix is ​​derived from human serum (provided by clinical institutions or blood donation centers); optionally, the human serum is subjected to harmless pretreatment according to conventional methods to avoid environmental pollution and disease transmission. The serum matrix is ​​not limited to be ultimately derived from the same source (such as the same mammalian subject), but can be a mixture of sera from multiple subjects.

[0055] After testing (such as but not limited to colloidal gold method), the serum matrix exhibits any one or combination selected from the following: HIV1 antibody negative, HIV2 antibody negative, hepatitis B surface antigen negative, hepatitis C virus antibody negative. "Negative" in this application refers to the presence of the analyte at a level that cannot be detected by the detection method; or its comple...

Embodiment 2

[0070] Embodiment 2. The preparation method of freeze-dried type quality control substance

[0071] According to conventional methods in the art, the quality control substance in Example 1 was freeze-dried.

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Abstract

This application discloses a quality control substance for a blood lipid test. Specifically, a disclosed composition comprises serum matrix, protective agent, preservative, total cholesterol, triglyceride, high density lipoprotein cholesterol, low density lipoprotein cholesterol, apolipoprotein A1, apolipoprotein B, lipoprotein (a), optional apolipoprotein E, optional phospholipid, optional homocysteine, optional C-reactive protein, and optional small and low density lipoprotein cholesterol. The application also relates to the use of this combination in the preparation of quality control substances. The quality control substance according to this application has excellent uniformity in and between bottles, while maintaining good stability.

Description

technical field [0001] This application relates to the field of clinical testing. More specifically, the present application relates to quality control substances used in various detection items in blood lipid detection. Background technique [0002] Blood lipid determination is not only of great significance for the diagnosis of hyperlipidemia and the risk assessment and prevention of coronary heart disease, but also has been applied to the research of many other clinical related professional diseases (Yan Shengkai, Chen Wenxiang; Chinese Journal of Cardiovascular Diseases, November 2004, No. 32 Volume 11). [0003] The methodology and standardization of blood lipid measurement is also a problem that has attracted widespread attention. The Laboratory Branch of the Chinese Medical Association is aimed at clinical serum total cholesterol (CHO), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein A1, li...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/531
CPCG01N33/531
Inventor 王晓建胡雅琦付红伟刘希
Owner BEIJING STRONG BIOTECH INC
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