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Calibrator and quality control product of anti-eb virus capsid antigen and early antigen antibody and preparation method thereof

A technology of Epstein-Barr virus and early antigen, applied in the direction of disease diagnosis, material inspection products, instruments, etc., can solve the problems of inability to quantify, inaccurate detection, and unguaranteed quality, and achieve shortened exploration time, simple preparation process, and improved specific effect

Active Publication Date: 2021-09-07
SUN YAT SEN UNIV CANCER CENT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The third method is the emerging chemiluminescence detection method, which has the characteristics of automation and high precision. The disadvantage is that the cost is higher than that of the ELISA method, and the manufacturer generally gives the number of photons and calculates the quantitative results through the calibrators assigned by each manufacturer.
First of all, due to the lack of standard products, the ELISA method can only screen out negative and positive results, which cannot be quantified, and clinical efficacy monitoring cannot be carried out; secondly, my country has many production VCA-IgA and EA-IgA antibody ELISA and chemiluminescent kits. Manufacturers, the results of various testing methods cannot be compared uniformly, resulting in waste of repeated testing
[0004] The ELISA method is affected by many factors in actual operation, which can easily lead to the deviation of the detection results. In order to improve the accuracy of the experiment, the setting of critical value quality control is very important.
At present, there is a lack of effective quality control serum for nasopharyngeal carcinoma ELISA detection critical value on the market. Conventional ELISA kits are often only equipped with negative and strong positive quality controls, which cannot effectively monitor the results of the gray zone.
Clinical laboratories need time-consuming and labor-intensive configuration of critical value quality control, and there are many difficulties in obtaining critical value quality control serum from clinical samples, and there is a lack of uniform standards, and the quality is not guaranteed
At present, the configuration of critical value quality control products mostly uses positive serum and negative serum for a certain proportion of dilution configuration. The ELSIA method needs to detect the S / CO value multiple times to screen out the appropriate concentration, which is time-consuming and labor-intensive.
Moreover, the linear result of the ELISA method is far inferior to that of the IFA method. The detection of the high value of VCA-IgA antibody in patients with nasopharyngeal carcinoma has obvious posterior band phenomenon, which makes the detection inaccurate.

Method used

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  • Calibrator and quality control product of anti-eb virus capsid antigen and early antigen antibody and preparation method thereof
  • Calibrator and quality control product of anti-eb virus capsid antigen and early antigen antibody and preparation method thereof
  • Calibrator and quality control product of anti-eb virus capsid antigen and early antigen antibody and preparation method thereof

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preparation example Construction

[0039] A kind of preparation method of the calibrator of the capsid antigen of anti-Epstein-Barr virus and the IgA antibody of early antigen, the steps are as follows:

[0040] 1) Select nasopharyngeal carcinoma patient plasma containing Epstein-Barr virus VCA-IgA and EA-IgA antibodies and normal human plasma negative for Epstein-Barr virus VCA-IgA and EA-IgA antibodies by immunofluorescence method, and centrifuge to remove the precipitate respectively;

[0041] 2) Add a calcium chloride water bath to the plasma treated in step 1), centrifuge to take the supernatant, mix the nasopharyngeal carcinoma plasma and normal human plasma in proportion, and filter through a filter membrane to prepare VCA-IgA and EA-IgA antibody calibration products.

[0042] A kind of preparation method of the quality control product of the capsid antigen of anti-Epstein-Barr virus and the IgA antibody of early antigen, the steps are as follows:

[0043] 1) By immunofluorescence method, select nasophar...

Embodiment 1

[0058] The preparation method of embodiment 1 calibrator

[0059] (1) Select plasma, Epstein-Barr virus VCA-IgA and EA-IgA antibodies of nasopharyngeal carcinoma patients with EB virus VCA-IgA titer of 1:1280 and EA-IgA antibody titer of 1:320 by immunofluorescence method (IFA) For negative normal human plasma, centrifuge to remove precipitates and interfering substances;

[0060] (2) Add 18mmol / L calcium chloride to the plasma treated in step (1), place in a constant temperature water bath at 38°C for 2 hours, centrifuge at 10,000rpm for 30 minutes, separate, and take the supernatant. Mix nasopharyngeal carcinoma plasma and normal human plasma at a ratio of 1:8, and filter through 0.2 μm cellulose acetate membrane to prepare VCA-IgA and EA-IgA antibody calibration products;

[0061] (3) Subpackage the prepared calibrator, add preservative and 50g / L lyoprotectant, freeze-dry into lyophilized powder for storage.

Embodiment 2

[0062] The preparation method of embodiment 2 calibrator

[0063] (1) Select plasma, Epstein-Barr virus VCA-IgA and EA-IgA antibodies of nasopharyngeal carcinoma patients with EB virus VCA-IgA titer of 1:800 and EA-IgA antibody titer of 1:220 by immunofluorescence method (IFA) For negative normal human plasma, centrifuge to remove precipitates and interfering substances;

[0064] (2) Add 18mmol / L calcium chloride to the plasma treated in step (1), place in a constant temperature water bath at 35°C for 2 hours, centrifuge at 10,000rpm for 30 minutes, separate, and take the supernatant. Nasopharyngeal carcinoma plasma and normal human plasma were mixed at a ratio of 1:5, and filtered through a 0.2 μm cellulose acetate membrane to obtain VCA-IgA and EA-IgA antibody calibrators;

[0065] (3) Subpackage the prepared calibrator, add preservative and 10g / L lyoprotectant, freeze-dry into lyophilized powder for storage.

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Abstract

The invention discloses a calibration product and a quality control product of anti-EB virus capsid antigen and early antigen antibody and a preparation method thereof. The raw material of the present invention is easy to obtain, the preparation process is simple, the calibration curve prepared by the calibrator is highly correlated, true and reliable, the NPC positive rate of VCA and EA detected by the present invention is high, and it has high accuracy, good sensitivity, strong specificity and stability Good features can be used to monitor the curative effect of clinical patients. Further improved the product performance of anti-Epstein-Barr virus VCA-IgA and EA-IgA antibody calibrator and quality control products, playing an important role in the field of biological detection.

Description

technical field [0001] The invention relates to a calibration product and a quality control product of anti-EB virus capsid antigen and early antigen antibody and a preparation method thereof, belonging to the field of biological detection. Background technique [0002] Nasopharyngeal carcinoma is a common head and neck tumor in my country, and its occurrence is related to Epstein-Barr virus. We detect the capsid antigen antibody (VCA-IgA) and early antigen antibody (EA-IgA) of Epstein-Barr virus to screen and observe the curative effect of nasopharyngeal carcinoma. At present, the recognized antibody serological detection method for VCA-IgA and EA-IgA is immunofluorescence (IFA). The whole protein of VCA is used as the antigen for the detection of VCA-IgA antibody, which has the characteristics of high specificity, and the titer The semi-quantitative results are useful for monitoring clinical efficacy. However, IFA has weak automation, strong subjectivity, and high equipm...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/68G01N33/574G01N33/569G01N33/531
CPCG01N33/531G01N33/56983G01N33/57407G01N33/6854G01N2800/14
Inventor 刘万里陈浩陈树林毛敏杰刘纹李林芳
Owner SUN YAT SEN UNIV CANCER CENT