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Test strip for simultaneously detecting gynecological tumor markers HER-2 and HE4

A HER-2, gynecological tumor technology, applied in measurement devices, scientific instruments, instruments, etc., can solve the problems of only single detection, low sensitivity and low specificity of the kit, and improve the detection sensitivity and improve the credibility of the results. degree, the effect of reducing background noise

Inactive Publication Date: 2019-02-15
JIANGSU INST OF NUCLEAR MEDICINE +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The former of the above-mentioned kits is only for the detection of breast cancer, and the latter is only for the detection of ovarian cancer and uterine cancer. There is a defect that it can only detect a single gynecological tumor marker, resulting in the need for clinical diagnosis, treatment and prognosis of human gynecological tumors. It takes a long time and the efficiency is low. At the same time, the sensitivity and specificity of the above-mentioned kits are low, and the errors caused by multiple individual tests are large, which in turn leads to low reliability of the test results.

Method used

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  • Test strip for simultaneously detecting gynecological tumor markers HER-2 and HE4
  • Test strip for simultaneously detecting gynecological tumor markers HER-2 and HE4
  • Test strip for simultaneously detecting gynecological tumor markers HER-2 and HE4

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Embodiment 1 Preparation of HER-2-T antibody and HE4-T antibody

[0038] The amino acid sequences shown in SEQ ID NO: 1 and SEQ ID NO: 2 are respectively used as HER-2-T-1 antigen and HER-2-T-2 antigen to immunize animals, thereby using the above antigens to prepare specific HER-2- T-1 and HER-2-T-2 monoclonal or polyclonal antibodies. Similarly, the amino acid sequences shown in SEQ ID NO: 3 and SEQ ID NO: 4 are respectively used as HE4-T-1 antigen and HE4-T-2 antigen to immunize animals, thereby using the above antigens to prepare specific HE4-T-1 and HE4-T-2 monoclonal or polyclonal antibody. HER-2-T-1 and HER-2-T-2 are referred to as HER-2-T-1 / 2 for short, and HE4-T-1 and HE4-T-2 are referred to as HE4-T-1 / 2 for short.

[0039] 1 Immunization of animals to prepare monoclonal antibodies:

[0040] 1.1. Take the above-mentioned HER-2-T-1 antigen, HER-2-T-2 antigen, HE4-T-1 antigen and HE4-T-2 antigen (immunogen) respectively with an equal volume of Freund's complete...

Embodiment 2

[0053] Example 2: Specific identification of human HER-2-T-1 / 2 antibody and HE4-T-1 / 2 antibody

[0054] Detection was performed by ELISA. Human HER-2, human HE4, carcinoembryonic antigen (CEA), and neuron-specific enolase (NSE) (all purchased from Sigma) were used as detection antigens to coat ELISA plates, and then the prepared HER- The specific reaction of 2-T-1 / 2 monoclonal antibody and HE4-T-1 / 2 monoclonal antibody with the antigen plate, normal BALB / c mouse serum was used as negative control, and PBS solution was used as blank control.

[0055] Results: HER-2-T-1 / 2 monoclonal antibody only reacted positively with HER-2 (P / N>2.1), HE4-T-1 / 2 monoclonal antibody only reacted positively with HE4 (P / N >2.1), but negative with CEA and NSE reactions, it shows that the HER-2-T-1 / 2 monoclonal antibody and HE4-T-1 / 2 monoclonal antibody of the present invention have specificity.

[0056] Using the above method to identify the specificity of HER-2-T-1 / 2 polyclonal antibody and HE4-...

Embodiment 3

[0057] Example 3 Preparation of test strips for simultaneous detection of gynecological tumor markers HER-2 and HE4

[0058] This embodiment provides a test strip for detecting gynecological tumor markers HER-2 and HE4, such as figure 1 with figure 2 shown, including:

[0059] Bottom plate 1, and absorbent paper 3, nitrocellulose membrane 2, binding pad 5 and sample pad 4 that are sequentially pasted on the bottom plate 1 along the length direction of the bottom plate 1; wherein, the nitrocellulose membrane 2 is glued Covering the middle part of the bottom plate 1, between the absorbent paper 3, the nitrocellulose membrane 2, the binding pad 5 and the sample pad 4, in turn and only in contact with the adjacent parts and partially overlapping;

[0060] The nitrocellulose membrane 2 is provided with a first detection zone 8 sprayed with HER-2-T-1 antibody, a second detection zone 7 of HE4-T-1 antibody, and a goat anti-mouse polyclonal sprayed with spaced intervals. The anti...

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Abstract

The invention belongs to the technical field of immunoassay, and particularly relates to a test strip for simultaneously detecting gynecological tumor markers HER-2 and HE4 and use of the test strip.A first detection zone of a first HER-2 antibody, a second detection zone of a first HE4 antibody and a quality control zone of a goat anti-mouse polyclonal antibody are alternately arranged on a nitrocellulose membrane in the test strip; and a binding pad is sprayed with polymer nanospheres having surfaces respectively modified with a second HER-2 antibody and a second HE4 antibody and containingtracers. The test strip can simultaneously detect two tumor markers human HER-2 and HE4 by a time-resolved fluorescence immunoassay method, and helps simultaneous analysis of breast cancer, ovarian cancer and endometrial cancer; and two results can be obtained based on a single operation of the test strip, thereby improving efficiency of screening and clinical interpretation, reducing errors caused by individual test, and benefiting screening and diagnosis of gynecological tumors.

Description

technical field [0001] The invention belongs to the technical field of immunoassay, and in particular relates to a test strip for simultaneously detecting gynecological tumor markers HER-2 and HE4 and its application. Background technique [0002] Cancer has become a major problem threatening public health. In recent years, compared with men, the incidence of cancer in Chinese women has shown a significant increase of 2.2% per year. Among them, the morbidity and mortality of female idiopathic breast cancer, ovarian cancer and uterine cancer are increasing year by year. Breast cancer accounts for 15% of new cancers in women, uterine cancer accounts for 3.6%, and ovarian cancer accounts for 3%. significantly increased in rural areas. In response to the high incidence of idiopathic breast cancer, ovarian cancer and uterine cancer in Chinese women, early detection, early diagnosis and early treatment are one of the effective means to improve the survival rate of patients. Ser...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/574G01N33/533G01N33/558
CPCG01N33/533G01N33/558G01N33/57484
Inventor 张艺郭明明周彬范俊张珏谢敏浩李文新
Owner JIANGSU INST OF NUCLEAR MEDICINE