Manufacture and application methods of hepatitis B surface antigen serum laboratory quality control material

A hepatitis B surface antigen and indoor quality control technology, applied in the medical field, can solve the problems of no preparation and use methods, inability to be sensitive to system variables and discover system problems, and achieve basic process optimization and long-term help, complete preparation and use methods , Optimizing the effect of the production process

Inactive Publication Date: 2016-12-07
CHANGSHA KINGMED MEDICAL DIAGNOSTICS INST
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] Among the relevant patents that have been applied for in China, there is no existing patent on hepatitis B quality control products, that is, in the related technical field, the complete operation method and process are still blank, there is no complete and clear preparation and use method, let alone Sensitivity to system variables and discover system problems and make continuous improvements

Method used

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Experimental program
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Embodiment Construction

[0031] A kind of manufacture method of hepatitis B surface antigen serum indoor quality control product, comprises the steps:

[0032] 1) Raw material collection and screening:

[0033] ①Collect HBsAg-positive and negative plasma or serum, mark the hepatitis B-positive plasma or serum and hepatitis B-negative plasma or serum separately, and screen the plasma or serum without obvious hemolysis, jaundice, fat or contamination as a reserve plasma or serum;

[0034] ② Determine the four items of infection (TPPA, HbSAg, HIV, HCV-IgG) on the preparatory plasma or serum screened in step ①, and screen out the negative plasma or serum as the spare plasma or serum;

[0035] 2) Production of diluted serum:

[0036] ① Place the spare plasma or serum obtained in 1) in an environment of 55°C-60°C, keep it warm for 0.5-1h, and perform inactivation treatment;

[0037] ② Centrifuge the inactivated plasma or serum in step ①, the centrifugation speed is 3000-3500r / min, and the centrifugation ...

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Abstract

The invention discloses manufacture and application methods of a hepatitis B surface antigen serum laboratory quality control material. The manufacture method comprises five steps as follows: acquisition and screening of raw materials, diluted serum manufacturing, preservation and monitoring of a standby quality control material, quality control, continuous improvement, etc. The application method comprises three steps as follows: storage, re-dissolution and application. The manufacture and application methods of the hepatitis B surface antigen serum laboratory quality control material are complete and clear. Due to the usage of a quality control chart of multiple impact factors, accuracy is high and control range is wide. By adoption of 31S quality control limit which is very sensitive to the system problem of unreasonable fundamental technological processes caused by insufficient technical capacity in the production process, the method is helpful for guaranteeing accuracy of the technological direction and determining good technological foundation and optimizing production technology.

Description

technical field [0001] The invention relates to the medical field, in particular to a method for manufacturing and using an indoor quality control product of hepatitis B surface antigen serum. Background technique [0002] A quality control is a quality control substance (fixed and non-fixed) used in in vitro diagnostics, a substance, material, article or device intended for use in a testing system intended for medical use, 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 substances (fixed value and non-fixed value), which can be used for proficiency testing and quality control in the laboratory. [0003] Among the relevant patents that have been applied for in China, there is no existing patent on hepatitis B quality control products, that is, in the related technical field, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/576G01N33/531
CPCG01N33/531G01N33/5764
Inventor 向玉珍刘程荣唐春燕刘文琼欧阳伟李慧源周梅华代冰
Owner CHANGSHA KINGMED MEDICAL DIAGNOSTICS INST
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