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Composite calibration product containing six indexes and having high anti-interference ability, and preparation method thereof

A calibrator and index technology, applied in the biological field, can solve the problems of high application cost, affecting the accuracy of in vitro diagnostic reagent test results, affecting the performance of calibrator, etc., and achieve the effect of improving stability

Inactive Publication Date: 2019-07-26
BIOBASE BIODUSTRY (SHANDONG) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The cfas calibrator developed by foreign companies such as Roche can provide calibration for more than 30 diagnostic reagents. It is in the state of freeze-dried powder, and the stability time can reach 2 years. It includes many biochemical items, but its application cost is relatively high.
Moreover, when there are many biochemical items contained in the composite calibrator, there will be some interference among the items, which will affect the performance of the calibrator, and then affect the accuracy of the test results of the in vitro diagnostic reagents.

Method used

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  • Composite calibration product containing six indexes and having high anti-interference ability, and preparation method thereof
  • Composite calibration product containing six indexes and having high anti-interference ability, and preparation method thereof
  • Composite calibration product containing six indexes and having high anti-interference ability, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] A composite calibrator containing 6 indicators with strong anti-interference ability, the matrix is ​​fetal bovine serum, and the contents of the 6 indicators are as follows:

[0032]

[0033] The content of each anti-interfering substance in the serum matrix is ​​as follows:

[0034]

[0035] Among them, Genapol X 80 and Emulgen A90 are surfactants, FAD is adenine flavin, and ADP is disodium adenosine diphosphate.

[0036] The preparation method of above-mentioned composite calibrator comprises the steps:

[0037] Step 1: Separating and filtering the collected blood to obtain serum as a matrix;

[0038] In this step, the method of obtaining serum from the collected blood can adopt the centrifugal separation method commonly used in the prior art, and can be filtered with a 0.22um filter.

[0039] Step 2: Add mannitol, Genapol X 80, ascorbic acid, EmulgenA90, FAD, ADP, polyoxyethylene 8000 and glutathione to the matrix in step 1 according to the content requireme...

Embodiment 2

[0049] A composite calibrator containing 6 indicators with strong anti-interference ability, the matrix is ​​fetal bovine serum, and the contents of the 6 indicators are as follows:

[0050]

[0051] The content of each anti-interfering substance in the serum matrix is ​​as follows:

[0052]

[0053] The preparation method is the same as in Example 1.

Embodiment 3

[0055] A composite calibrator containing 6 indicators with strong anti-interference ability, the matrix is ​​fetal bovine serum, and the contents of the 6 indicators are as follows:

[0056]

[0057] The content of each anti-interfering substance in the serum matrix is ​​as follows:

[0058]

[0059]

[0060] The preparation method is the same as in Example 1.

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Abstract

The invention discloses a composite calibration product containing six indexes and having high anti-interference ability, and a preparation method thereof, and relates to the field of biotechnology. The matrix of the composite calibration product is serum, the six index components are apolipoprotein A1, apolipoprotein B, high density lipoprotein cholesterol, low density lipoprotein cholesterin, total cholesterol and triglyceride, and the matrix contains anti-interference substances: mannitol, Genapol X 80, ascorbic acid, Emulgen A90, FAD, ADP, polyoxyethylene 8000 and glutathione. According tothe composite calibration product disclosed by the invention, the anti-interference substances are fully and evenly mixed at first, and then the 6 indexes are added in sequence, so that full play isgiven to the anti-interference substances added to the serum matrix, and the prepared composite calibration product can not only reduce the interference between a plurality of indexes in the product,but also can improve the stability.

Description

technical field [0001] The invention relates to the field of biotechnology, in particular to a composite calibrator with strong anti-interference ability containing six indicators and a preparation method thereof. Background technique [0002] With the improvement of China's living standards, the medical level of the Chinese people is also improving step by step, and my country's in vitro diagnostic reagents have made a qualitative leap between 2000 and 2018. Through domestic and foreign exchanges, technology introduction and independent development, my country's in vitro diagnostic reagent industry is springing up and ready to go. In vitro diagnostic reagent calibrators and quality control products are the main tools to achieve accurate results of clinical testing and supervisory testing of in vitro diagnostic reagents, and their quality is directly related to the diagnosis of human diseases. Calibrators are commonly used substances in clinical practice. When changing kit ...

Claims

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Application Information

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IPC IPC(8): G01N1/28G01N1/42
CPCG01N1/28G01N1/42G01N2001/2893
Inventor 宋现让甘宜梧韩重谢清华胡晓飞罗维晓董雯李志明
Owner BIOBASE BIODUSTRY (SHANDONG) CO LTD
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