Liver fibrosis marker control material and preparation method thereof

A technology for liver fibrosis and quality control materials, which is applied in the preparation of test samples, chemiluminescence/bioluminescence, and analysis by chemical reaction of materials, etc. Good uniformity and stability, low cost effect

Inactive Publication Date: 2019-03-08
AUTOBIO DIAGNOSTICS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The quality control products provided by commercial reagent manufacturers cannot be used for the detection of all quantitative items of liver fibrosis

Method used

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  • Liver fibrosis marker control material and preparation method thereof
  • Liver fibrosis marker control material and preparation method thereof
  • Liver fibrosis marker control material and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1 Preparation of Liver Fibrosis Marker Substance Control

[0024] Six levels of liver fibrosis markers (Q1: HA-70ng / mL, LN-70ng / mL, PIIINP-5ng / mL, CIV-50ng / mL, CG-1.5μg / mL; Q2: HA-100ng / mL , LN-100ng / mL, PIIINP-10ng / mL, CIV-100ng / mL, CG-2.5μg / mL; Q3: HA-150ng / mL, LN-150ng / mL, PIIINP-15ng / mL, CIV-150ng / mL mL, CG-5.0μg / mL; Q4: HA-250ng / mL, LN-250ng / mL, PIIINP-35ng / mL, CIV-250ng / mL, CG-10μg / mL; Q5: HA-500ng / mL, LN -500ng / mL, PIIINP-50ng / mL, CIV-500ng / mL, CG-25μg / mL; Q6: HA-700ng / mL, LN-700ng / mL, PIIINP-70ng / mL, CIV-700ng / mL, CG -40 μg / mL).

[0025] 1. Select healthy adults who are negative for infectious markers such as HBsAg, anti-HCV, anti-specific TP, and anti-HIV in blood as qualified blood donors, and collect liver fibrosis-negative mixed serum;

[0026] 2. Treat the above-mentioned hepatic fibrosis-negative mixed serum in a 56°C water bath for 2 hours, then centrifuge it in a high-speed centrifuge (3500r / min≤speed≤8000r / min) for 10 minutes, and store it at...

Embodiment 2

[0032] Embodiment 2 The performance test of the quality control product of the present invention

[0033] The homogeneity and stability of liver fibrosis marker controls were assessed. Through the statistical analysis of the performance evaluation results, it is verified whether the indicators meet the requirements of the experimental design.

[0034] 1. Uniformity verification

[0035] Take 10 bottles of each level of quality control products of the same batch number, each bottle of quality control products is tested once with the corresponding reagent, and the average value of the 10 test results is calculated according to formulas 1 and 2 ( ) and standard deviation S1;

[0036] In addition, use 1 bottle of the above-mentioned 10 bottles of quality control products for 10 consecutive tests, and calculate the average value of 10 test results ( ) and standard deviation S2; calculate the coefficient of variation CV between bottles according to the following formula, and th...

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Abstract

The invention discloses a liver fibrosis marker control material. The liver fibrosis marker control material is a lyophilized product prepared from matrix diluent, hyaluronic acid (HA), laminin (LN),type III procollagen (PIIINP), type IV collagen (Col IV) and glycocholic acid (CG). The control material prepared by the invention has the advantages of good uniformity and stability, free from influence of transportation, temperature and the like, suitability for quantitative detection of different instrument models and different reagents, as well as detection operation of different laboratory personnel in different regions. After the control material is redissolved, the detection process has a longer stable time, detection repeatability and high accuracy are realised; the quality control requirements of clinical detection of a liver fibrosis marker can be met and further the accuracy of clinical sample test results can be detected more accurately.

Description

technical field [0001] The invention relates to biological product technology, in particular to a hepatic fibrosis marker substance control substance, and also relates to a preparation method of the quality control substance. Background technique [0002] The formation of hepatic fibrosis is due to the loss of balance between the liver's control of matrix formation and deposition and matrix degradation and clearance, resulting in excessive deposition of connective tissue and fibrosis. Liver fibrosis is the common pathological basis of chronic liver diseases, and liver fibrosis can gradually form with the progress of various chronic liver diseases. [0003] The diagnosis of liver fibrosis mainly includes histological examination, imaging examination and serological examination of liver biopsy samples. At present, the most reliable indicator for evaluating the degree of liver fibrosis and its activity is still the histological examination of liver biopsy samples, which is cal...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N1/28G01N21/76
CPCG01N1/28G01N21/76
Inventor 李忠信谢茜尹伊
Owner AUTOBIO DIAGNOSTICS CO LTD
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