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Quantitative indoor quality control substance for whole-blood EBV-DNA

A technology of EBV-DNA and quantitative chamber, which is applied in the direction of measuring devices, preparation of test samples, instruments, etc., can solve the problems of lack of whole blood EBV quality control products, and achieve reliable test results, clear production process, and quality assurance Effect

Inactive Publication Date: 2017-11-21
CHANGSHA KINGMED MEDICAL DIAGNOSTICS INST
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  • Application Information

AI Technical Summary

Problems solved by technology

The main advantage of real-time fluorescent PCR detection method is that it can accurately quantify EBV-DNA, which helps to diagnose early infection of the virus and reduce the blindness of diagnosis and treatment. It has certain significance for clinical diagnosis and treatment, but there is no suitable comprehensive method. Blood EBV Quality Control

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  • Quantitative indoor quality control substance for whole-blood EBV-DNA
  • Quantitative indoor quality control substance for whole-blood EBV-DNA
  • Quantitative indoor quality control substance for whole-blood EBV-DNA

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Embodiment Construction

[0041] The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only some, not all, embodiments of the present invention.

[0042] see figure 1 , is a flow chart of the preparation method 1 of the whole blood EBV-DNA quantitative internal quality control product provided by the present invention.

[0043] The preparation method 1 of the whole blood EBV-DNA quantitative indoor quality control product comprises the following steps:

[0044] S1: Sample collection:

[0045] Collect several whole blood samples with negative EBV-DNA test results, and the test results are greater than 10 6 Several whole blood samples of IU / mL are recorded as negative samples and positive samples respectively;

[0046] S2: Sample configuration:

[0047] Prepare three 45mL sample tubes, take 90mL of the negati...

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Abstract

The invention provides a quantitative indoor quality control substance for whole-blood EBV-DNA. A preparation method for the quantitative indoor quality control substance comprises the following steps: sample collection; sample preparation; acquisition of a standby high value; acquisition of a standby low value; corrosion prevention; determination of a quality control value; determination of the quality control substance; storage; etc. A validation method for the quantitative indoor quality control substance comprises stability assessment, uniformity assessment and anti-corrosion assessment. A quality control method using the quantitative indoor quality control substance comprises quality control analysis, setting of quality control rules and other steps. The quantitative indoor quality control substance for whole-blood EBV-DNA in the invention overcomes the technical problem that a real-time fluorescent PCR detection method does not have a proper whole-blood EBV quality control substance during EBV detection in the prior art.

Description

technical field [0001] The invention relates to the field of gene detection, in particular to a whole blood EBV-DNA quantitative indoor quality control product. Background technique [0002] EBV is a source of infection closely related to diseases such as nasopharyngeal carcinoma, infectious mononucleosis, and childhood lymphoma. Targeted quantitative detection of EBV-DNA is of great significance for the screening and diagnosis of related diseases . [0003] Since EBV mainly infects the epithelial cells and B lymphocytes of the human oropharynx, the detection of whole blood cells is better than the detection of serology. [0004] At present, there are mainly immunoassays and real-time fluorescent PCR detection methods used in the detection of EBV. The main advantage of real-time fluorescent PCR detection method is that it can accurately quantify EBV-DNA, which is helpful to diagnose early infection of the virus and reduce the blindness of diagnosis and treatment. It has ce...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N1/28G01N21/64
CPCG01N1/28G01N21/6428G01N2001/2893
Inventor 田倩李欣荣贺乐刘岱璿唐笑何媛周梅华代冰彭兴旺
Owner CHANGSHA KINGMED MEDICAL DIAGNOSTICS INST
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