Search

CN-122029430-A - Colloid detection kit and detection card for diagnosing and screening nasopharyngeal carcinoma and application thereof

CN122029430ACN 122029430 ACN122029430 ACN 122029430ACN-122029430-A

Abstract

The application relates to a detection kit for diagnosing and screening nasopharyngeal carcinoma, which comprises an immunochromatography detection card, wherein the immunochromatography detection card comprises a reagent for detecting an EB virus antigen antibody by a colloidal gold labeling method. The application also relates to the application of the detection card and the EB virus antigen antibody in preparing a detection kit or a detection card for diagnosing and screening nasopharyngeal carcinoma.

Inventors

  • YU HAOYANG
  • XU HUALIN
  • CHENG XIAOJIE
  • LIANG NING
  • Deng si
  • Zhang Jianggu

Assignees

  • 深圳市晋百慧生物有限公司

Dates

Publication Date
20260512
Application Date
20250324
Priority Date
20240407

Claims (10)

  1. A detection kit for diagnosing and screening nasopharyngeal carcinoma comprises an immunochromatography detection card which comprises a reagent for detecting EB virus early antigen antibodies by a colloidal gold labeling method, The early antigen is preferably EAD-P47/54, more preferably it has the sequence shown in SEQ ID No. 1, and/or The antibody is preferably an IgG antibody.
  2. The detection kit according to claim 1, wherein the detection card comprises a sample pad, a colloidal gold pad, a detection line T, a quality control line C and absorbent paper according to the sample flow direction, the colloidal gold pad is coated with the early antigen of the EB virus marked by the colloidal gold, the detection line T is coated with a secondary antibody of an antibody to be detected, and the secondary antibody is preferably an anti-human IgG antibody.
  3. The test kit of claim 1 or 2, wherein the test card further comprises reagents for quality control.
  4. The detection kit of claim 3, wherein the reagents for quality control are: A colloidal gold-labeled antigen coated in a colloidal gold pad, and an antibody to the antigen coated in a quality control line C, or A colloidal gold-labeled antibody coated in the colloidal gold pad, and a secondary antibody of the antibody or an antigen against which the antibody is coated on the quality control line C, Preferably, the colloidal gold-labeled antibody is chicken IgY, and correspondingly, the secondary antibody of the chicken IgY is coated on the quality control line.
  5. The application of EB virus early antigen in preparing immunochromatography detection card or detection kit for diagnosing and screening nasopharyngeal carcinoma, wherein: The detection kit comprises the immunochromatographic detection card, which is the immunochromatographic detection card according to any one of claims 1 to 4.
  6. An immunochromatographic assay card according to any one of claims 1 to 4.
  7. A detection kit for diagnosing and screening nasopharyngeal carcinoma comprises an immunochromatography detection card containing a reagent for detecting EB virus antigen antibodies by a colloidal gold labeling method, wherein the immunochromatography detection card comprises an immunochromatography detection card for detecting Zta-IgG antibodies and/or an immunochromatography detection card for detecting EBNA-IgA antibodies, and can further comprise an immunochromatography detection card for detecting Early Antigen (EA) -IgG antibodies, wherein: The EA is preferably EAD-P47/54, more preferably it has the sequence shown in SEQ ID No. 1, the Zta is preferably the sequence shown in SEQ ID No. 2, and the EBNA is preferably EBV nuclear antigen 1 (EBNA 1), more preferably it has the sequence shown in SEQ ID No. 3.
  8. The detection kit according to claim 1, wherein the detection card comprises a sample pad, a colloidal gold pad, a detection line T, a quality control line C and absorbent paper according to the sample flow direction, the colloidal gold pad is coated with the early antigen of the EB virus marked by the colloidal gold, the detection line T is coated with a secondary antibody of an antibody to be detected, and the secondary antibody is preferably an anti-human IgG antibody.
  9. The test kit of claim 7 or 8, wherein the test card further comprises reagents for quality control.
  10. The detection kit of claim 9, wherein the reagents for quality control are: A colloidal gold-labeled antigen coated in a colloidal gold pad, and an antibody to the antigen coated in a quality control line C, or A colloidal gold-labeled antibody coated in the colloidal gold pad, and a secondary antibody of the antibody or an antigen against which the antibody is coated on the quality control line C, Preferably, the colloidal gold-labeled antibody is chicken IgY, and correspondingly, the secondary antibody of the chicken IgY is coated on the quality control line.

Description

Colloid detection kit and detection card for diagnosing and screening nasopharyngeal carcinoma and application thereof Technical Field The application relates to the field of immunology, in particular to a nasopharyngeal carcinoma diagnosis and screening, and more particularly relates to a colloidal gold detection kit, a detection card and application thereof for diagnosing and screening nasopharyngeal carcinoma. Background Nasopharyngeal carcinoma (Nasopharyngeal Carcinoma, NPC) is a common malignant tumor in otorhinolaryngology, and is characterized by malignant tumor originating from nasopharyngeal mucosa epithelial cells, is a special type of head and neck malignant tumor, and is highly developed in southeast Asia, africa, middle and southern coastal areas of China, especially in Guangdong and Guangxi areas, the annual incidence rate is about 30/10 ten thousand, the total incidence accounts for more than half of the world, and a series of serious health problems of people are caused. The pathological and anatomical characteristics of the nasopharyngeal carcinoma determine the comprehensive treatment mainly based on radiotherapy, clinical stage is closely related to prognosis of patients, and the total survival rate of early nasopharyngeal carcinoma patients for 5 years is up to more than 90%. Early intervention can be seen to greatly improve long-term survival of patients. Therefore, the screening technology and the scheme with high efficiency, easy implementation and high cost performance are explored, and the early diagnosis platform with wide coverage and strong accessibility is established, so that the method has important significance for improving the full-path management and diagnosis level of nasopharyngeal carcinoma, prolonging the life time of patients and improving the life quality. Nasopharyngeal carcinoma has very low incidence in most areas of the world, but has a high incidence in south China, especially Guangdong province, so it is also called 'Guangdong carcinoma' [1]. The statistics report of the Chinese cancer center shows that about 60,000 new cases of nasopharyngeal carcinoma in China and about 34,000 [2] death cases exist in 2015. In China, the incidence rate of nasopharyngeal carcinoma has great regional difference, increases from north to south in turn, and in some northern areas, the incidence rate of men is as low as 3/10 ten thousand people [1], but in the river areas of the West river and the Zhujiang river, the incidence rate is as high as 25-40/10 ten thousand people. Developed countries such as Europe and America have extremely low incidence rate of nasopharyngeal carcinoma, lack of research objects and have few researches. Therefore, most of the research on nasopharyngeal carcinoma is carried out in China. At present, the screening means of nasopharyngeal carcinoma in China mainly comprise endoscopy, EBV-DNA detection and serology detection. Among them, imaging examinations mainly using endoscopes (nasopharyngeal mirrors) are widely used in clinical and physical examinations. Combining with histopathological examination, the method is regarded as a gold standard for diagnosing nasopharyngeal carcinoma in China, and the nasopharyngeal mirror examination can find out the opposite hyperplasia of the nasopharyngeal epithelium in early stage, which belongs to the precancerous lesions of the nasopharyngeal carcinoma. However, the nasopharyngeal examination still has the problems of difficult discovery of early nasopharyngeal carcinoma, incorrect sampling success rate of biopsy, misdiagnosis risk and the like, and the nasopharyngeal examination belongs to invasive examination, has poor compliance, huge consumption of manpower and medical resources, is difficult to be applied to large-scale crowd screening, and has reports on nasopharyngeal injury and cross infection caused by insufficient experience of operators or improper equipment cleaning. Currently, EBV-DNA detection determines whether or not to infect EB virus and the extent of infection by analyzing the EB virus DNA content in the human plasma or serum of the subject. The method has the advantages that the existence of the virus can be directly detected, and the method has higher specificity [8] for early screening of nasopharyngeal carcinoma. However, the early diagnosis of EBV-DNA detection is poor, and it has been reported that this method has a specificity of up to 99.3% for detecting NPC patients, and a sensitivity of only 41.5% [9]. In addition, EBV-DNA detection has not been standardized, and its detection results are susceptible to factors such as experimental manipulation, sample quality, etc. The detection results may be different from laboratory to laboratory, and this difference affects not only the accuracy of the detection results, but also brings trouble to diagnosis and treatment of doctors. For serological detection of EBV antibodies, the currently used serological screening targets are VCA-IgA and EBNA1-