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Quality control product of inflammation marker and preparation method

A technology of quality control products and markers, applied in the field of clinical medical testing, to achieve the effects of easy promotion and use, high compliance, and simple preparation methods

Pending Publication Date: 2020-04-07
郑州标源生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In view of this, the object of the present invention is to provide a stable inflammatory marker substance control substance and its preparation method for the problems existing in the existing inflammation quality control substance

Method used

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  • Quality control product of inflammation marker and preparation method
  • Quality control product of inflammation marker and preparation method
  • Quality control product of inflammation marker and preparation method

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0034] The preparation method of inflammation quality control product described in the present invention, comprises the steps:

[0035] (1) Treatment of quality control matrix solution: reconstitute commercial human serum or plasma and return to room temperature, then place in a water bath at 42-65°C for 1-3 hours.

[0036] (2) Preparation of quality control matrix solution: add HEPES buffer 5-100mmol / L to adjust the pH to 5.0-9.0, add 0.01-5g / L aminopyrine, 0.05-5g / L Proclin300, 5-100g / L L trehalose, mixed evenly;

[0037]3) Preparation of quality control products: divide the prepared quality control product matrix solution into 3 levels of high, middle and low, and add positive high values ​​of inflammatory markers according to the content of the following inflammatory markers for testing: Procalcitonin (PCT) 0.01 -100ng / ml, C-reactive protein (CRP) 0-300mg / L, serum amyloid A (SAA) 10-200mg / L, myeloperoxidase (MPO) 50-1000ng / ml, interleukin-6 (IL -6) 10-1000 pg / ml, lipopro...

Embodiment 1

[0045] Embodiment 1: Inflammation marker substance control product of the present invention

[0046] The matrix solution is composed of the following components: normal human serum, 50mmol / L HEPES buffer, 2.0g / L aminopyrine, 50g / L trehalose, 2.0g / L Proclin300;

[0047] The content of the inflammatory markers:

[0048] 1) The content of the inflammatory markers in the high-level inflammation composite quality control product Procalcitonin (PCT) 20ng / ml, C-reactive protein (CRP) 25mg / L, serum amyloid A (SAA) 50mg / ml L. Myeloperoxidase (MPO) 500ng / ml, interleukin-6 (IL-6) 350pg / ml, lipoprotein-associated phospholipase (LP-PLA2) 1000μg / L;

[0049] 2) The contents of the inflammatory markers in the medium-level inflammation composite quality control product are procalcitonin (PCT) 1ng / ml, C-reactive protein (CRP) 5mg / L, serum amyloid A (SAA) 20mg / ml L. Myeloperoxidase (MPO) 400ng / ml, interleukin-6 (IL-6) 150pg / ml, lipoprotein-associated phospholipase (LP-PLA2) 400μg / L;

[0050] ...

Embodiment 2

[0051] Embodiment 2: Inflammation marker substance control product of the present invention

[0052] The matrix solution is composed of the following components: normal human plasma, 10mmol / L HEPES buffer, 1.0g / L aminopyrine, 30g / L trehalose, 1.0g / L Proclin300;

[0053] The content of the inflammatory markers:

[0054] 1) The content of the inflammatory markers in the high-level inflammation composite quality control product Procalcitonin (PCT) 20ng / ml, C-reactive protein (CRP) 25mg / L, serum amyloid A (SAA) 50mg / ml L. Myeloperoxidase (MPO) 500ng / ml, interleukin-6 (IL-6) 350pg / ml, lipoprotein-associated phospholipase (LP-PLA2) 1000μg / L;

[0055] 2) The contents of the inflammatory markers in the medium-level inflammation composite quality control product are procalcitonin (PCT) 1ng / ml, C-reactive protein (CRP) 5mg / L, serum amyloid A (SAA) 20mg / ml L. Myeloperoxidase (MPO) 400ng / ml, interleukin-6 (IL-6) 150pg / ml, lipoprotein-associated phospholipase (LP-PLA2) 400μg / L;

[0056]...

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Abstract

The invention belongs to the field of clinical medicine detection, and discloses a quality control product of an inflammatory marker and a preparation method of the quality control product. The quality control product of the inflammation marker is composed of a matrix liquid and an inflammation marker component, wherein the matrix liquid is composed of a matrix, a 5-100 mmol / L buffer agent, a 0.01-5 g / L protein protective agent, a 5-100 g / L saccharide and a 0.05-5 g / L preservative; the inflammation marker comprises the following components: procalcitonin, C reactive protein, serum amyloid protein A, myeloperoxidase, interleukin-6 and lipoprotein related phospholipase. The quality control product of the inflammatory marker contains a plurality of inflammatory markers, so that the joint detection of different inflammatory items is realized. Meanwhile, commercial human serum or plasma is adopted as a matrix, the channel source is stable, large-batch production can be achieved, the clinical sample conformity degree is high, the universality is high, the matrix effect can be reduced to the maximum extent, and the uniformity, stability and other performance are good.

Description

technical field [0001] The invention belongs to the field of clinical medical testing, and in particular relates to a quality control product of an inflammatory marker and a preparation method thereof. Background technique [0002] Quality control refers to quality control substances (fixed value and non-fixed value) used in in vitro diagnostics, which is a substance, material, article or equipment used in a detection system intended for medical purposes, the purpose of which is to evaluate or Verify performance characteristics such as measurement precision, measurement accuracy, and possible analytical bias of the detection system due to changes in reagents or analytical instruments. Quality control products can be used for proficiency testing, quality control in the laboratory, and for verifying the performance of analytical instruments or methods. [0003] The quality control product has the following characteristics: the composition of the quality control product should...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/96G01N33/68G01N33/573
CPCG01N33/96G01N33/6893G01N33/573G01N2800/60G01N2800/7095
Inventor 王新明刘俊英祖均丽张举刘功成
Owner 郑州标源生物科技有限公司
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