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Plasma endotoxin detection kit quality control product and preparation method thereof

A technology for detection kits and quality control products, which is applied in the field of plasma endotoxin detection kit quality control products and its preparation, can solve the problems of large differences in plasma, achieve long validity period, reduce matrix effect, and facilitate storage and transportation Effect

Inactive Publication Date: 2014-09-24
XIAMEN BIOENDO TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The matrix component is water for bacterial endotoxin testing, which is very different from the plasma of the test sample. There is no quality control product for quantitative detection of plasma endotoxin on the market.

Method used

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  • Plasma endotoxin detection kit quality control product and preparation method thereof
  • Plasma endotoxin detection kit quality control product and preparation method thereof
  • Plasma endotoxin detection kit quality control product and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] A plasma endotoxin detection kit quality control product, including a high-value quality control product and a low-value quality control product; the components of the high-value quality control product are finished human plasma with an endotoxin content of 1.8-2.2 EU / ml; The components of the low-value quality control product are finished human plasma with an endotoxin content of 0.3-0.7 EU / ml.

[0022] As a preferred embodiment of the embodiment, the matrix used in the high-value quality control and the low-value quality control is finished human plasma with an endotoxin content less than 0.01 EU / ml.

[0023] As a preferred mode of the embodiment, the high-value quality control substance and the low-value quality control substance are in the form of dry powder after freeze-drying.

[0024] As a preferred mode of the embodiment, the sample processing solution added to the endotoxin detection kit or the bacterial endotoxin test water is reconstituted into a liquid durin...

Embodiment 2

[0026] A method for preparing a plasma endotoxin detection kit quality control product, comprising the following steps:

[0027] Step 1. Use 200ml of finished human plasma, and perform quantitative detection of endotoxin according to the requirements of the plasma endotoxin detection kit instructions. If the endotoxin content is less than 0.01EU / ml, it can be used as a quality control matrix;

[0028] Step 2: Prepare 2 tubes of 100EU endotoxin standard solution, take endotoxin national working standard or endotoxin working standard, add 1ml bacterial endotoxin test water according to the instructions, vortex and mix for more than 15 minutes, and get 100EU / ml endotoxin Toxin standard solution;

[0029] Step 3: Take the endotoxin standard solution prepared in step 2, add 0.3ml of endotoxin standard solution to the quality control matrix in step 1 according to the ratio of adding 0.3ml of endotoxin standard solution per 100ml of quality control substance matrix, and use a magneti...

Embodiment 3

[0042] A method for preparing a plasma endotoxin detection kit quality control product, comprising the following steps:

[0043] Step 1. Use 200ml of finished human plasma, and perform quantitative detection of endotoxin according to the requirements of the plasma endotoxin detection kit instructions. If the endotoxin content is less than 0.01EU / ml, it can be used as a quality control matrix;

[0044] Step 2: Prepare 2 tubes of 100EU endotoxin standard solution, take endotoxin national working standard or endotoxin working standard, add 1ml bacterial endotoxin test water according to the instructions, vortex and mix for more than 15 minutes, and get 100EU / ml endotoxin Toxin standard solution;

[0045] Step 3: Take the endotoxin standard solution prepared in step 2, add 0.5ml of endotoxin standard solution to the quality control matrix in step 1 according to the ratio of adding 0.5ml of endotoxin standard solution per 100ml of quality control substance matrix, and use a magneti...

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Abstract

The invention discloses a plasma endotoxin detection kit quality control product. The plasma endotoxin detection kit quality control product comprises a high-value quality control product and a low-value quality control product; the ingredient of the high-value quality control product is finished product human plasma with the endotoxin content of 1.8 to 2.2 EU / ml; the ingredient of the low-value quality control product is finished product human plasma with the endotoxin content of 0.3 to 0.7 EU / ml. The invention also discloses a preparation method of the plasma endotoxin detection kit quality control product. The preparation method is characterized in that the finished product human plasma with low endotoxin is selected as a substrate material, so that the substrate effect can be reduced; by reasonably setting the endotoxin valence of the quality control product, the controllability of the quality control product can be enhanced. The quality control product prepared through the preparation method has the characteristics of good stability, small inter-bottle difference and long period of validity.

Description

technical field [0001] The invention relates to the technical field of biological products, in particular to a plasma endotoxin detection kit quality control product and a preparation method thereof. Background technique [0002] Sepsis caused by Gram-negative bacterial infection is an important cause of death in critically ill patients. Studies have demonstrated that many of the symptoms and signs of Gram-negative bacterial sepsis are caused by endotoxemia, both in humans and animals. Therefore, the level of plasma endotoxin in patients is an important specific indicator of severe bacterial inflammation, a reliable indicator of sepsis and multi-organ failure related to inflammatory activity, and an important parameter to monitor inflammatory activity. At present, the quantitative bacterial endotoxin detection kit based on the bypass reaction principle of Limulus test factor C can quantitatively detect bacterial endotoxin in human plasma within a few hours, and is used as a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N1/28
Inventor 不公告发明人
Owner XIAMEN BIOENDO TECH CO LTD
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