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Treating agent and application thereof

A treatment agent and reagent technology, applied in the treatment agent and its application field, can solve problems such as the reduction of detection sensitivity, and achieve the effects of improving detection sensitivity, reducing interference, and shortening detection window period.

Pending Publication Date: 2020-08-11
CHEMCLIN DIAGNOSTICS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, once HCV-infected patients produce antibodies in vivo and undergo seroconversion, antigen-antibody complexes can be formed between anti-core antigen antibodies and HCVcAg, and the detection sensitivity will be significantly reduced

Method used

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  • Treating agent and application thereof
  • Treating agent and application thereof
  • Treating agent and application thereof

Examples

Experimental program
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Effect test

specific Embodiment

[0073] In order to make the present invention easier to understand, the present invention will be further described in detail below in conjunction with examples, and these examples are for illustrative purposes only, and do not limit the scope of application of the present invention. The raw materials or components used in the present invention can be prepared by commercial channels or conventional methods unless otherwise specified.

[0074] The detection results in the following examples are all detection results using LITA HT.

[0075] In the following examples, the treatment agent is used to process the sample to be tested in the antigen well in the combined detection of HCV Ag / Ab. In the antigen well, other components include FG-HCV-Ab1 and Bio-HCV-Ab2 (two strains are aimed at HCV core Monoclonal antibodies with different epitopes of the antigen, one monoclonal antibody binds to the receptor, and the other monoclonal antibody binds to biotin). There are two ways to use ...

Embodiment 1

[0082] Embodiment 1: the impact of different concentrations of NaCl in the treatment agent on the detection sensitivity of HCV antigen

[0083] (1) The treating agent used includes: 10wt% urea, 3v% n-butanol, 1v% Triton X-114, 0.75wt% CTAB and NaCl; wherein the concentration of NaCl is shown in Table 1.

[0084] (2) Experimental method: use method 1 for detection, wherein the concentration of FG-HCV-Ab1 used is 100ug / ml, the concentration of Bio-HCV-Ab2 is 0.5ug / ml, and the sample to be tested is HCV diluted with negative serum Recombinant core antigen, test results are shown in Table 1.

[0085] Table 1

[0086]

[0087] It can be seen from Table 1 that with the increase of the concentration of sodium chloride in the treatment agent, the ratio of positive and negative signal values ​​in the test results increases significantly. It shows that increasing the concentration of sodium chloride can help to improve the sensitivity of antigen detection.

Embodiment 2

[0088] Embodiment 2: The impact of CTAB / Triton X-114 on the detection sensitivity of HCV antigen in the treatment agent

[0089]1) Use method 2 for detection, wherein the concentration of FG-HCV-Ab1 used is 100ug / ml, the concentration of Bio-HCV-Ab2 is 0.5ug / ml, and the sample to be tested is HCV recombinant core antigen diluted in phosphate buffer , and the test results are shown in Table 2.

[0090] Table 2

[0091]

[0092]

[0093] It can be seen from Table 2 that after adding surfactants, the ratio of positive and negative signal values ​​increased significantly, especially for CTAB, the increase effect was very obvious, indicating that adding surfactants can improve the sensitivity of antigen detection. The possible reason is that CTAB will bind to the protein and change the conformation of the core antigen, exposing the epitope bound by the selected antibody.

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Abstract

The invention relates to a treating agent and an application thereof in the technical field of immunodetection. The treating agent is prepared from the following components in percentage by weight of5wt%-15wt% of urea, 1 v%-5 v% of n-butyl alcohol, 0.5 wt%-2wt% of ionic surface active agent, 0.1 v%-2 v% of non-ionic surface active agent, and 5 wt%-15 wt% of metal salt. The treating agent disclosed by the invention can be used for cracking HCV viruses and denaturing core antigens, so HCV core epitopes are exposed, detection sensitivity of the HCV core antigens is improved,an HCV detection window period is further shortened; in addition, the treating agent disclosed by the invention can dissociate the low-affinity antibody, so interference of the early-stage in-vivo low-affinity antibody isreduced.

Description

technical field [0001] The invention belongs to the technical field of immunoassay, and in particular relates to a treatment agent and its application. Background technique [0002] When the body is infected with a pathogen, such as hepatitis C virus (HCV), the antigen is one of the infectious markers that appear before the antibody, and the detection of the antigen is used in serological examination as the most direct and earliest evidence of the existence of a pathogen , but due to the low detection rate, it is usually clinically used to detect antibodies as a sign of infection. After the pathogen infects the body, there is still a period of time for the emergence of antibodies. In this window period, the detection of antibodies will be missed, but the principle of antibodies can be detected. However, when a large number of antibodies appear in the serum, they combine with the antigen to form an antigen-antibody complex, which significantly reduces the sensitivity of anti...

Claims

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Application Information

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IPC IPC(8): G01N33/576
CPCG01N33/5767G01N33/54313G01N33/56983
Inventor 吴晨张林钰赵琪李临
Owner CHEMCLIN DIAGNOSTICS CO LTD
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