A monoclonal antibody combination for HPV18 type E6 protein detection and its application

By developing monoclonal antibody combinations and diabodyne sandwich detection methods for HPV18 type E6 protein, the sensitivity and false positive problems of existing cervical cancer screening methods are solved, and high specificity and high sensitivity detection of HPV18 type E6 protein is achieved, supporting the risk assessment of cervical precancerous lesions and vaccine development.

CN120329424BActive Publication Date: 2025-08-26BEIJING SUBENYUANHE BIOTECHNOLOGY CO LTD
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Patent Information

Application Number
CN202510831711.1
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2025-06-20
Publication Date
2025-08-26
Estimated Expiration
2045-06-20

AI Technical Summary

Technical Problem

Existing cervical cancer screening methods such as cervical cytology and HPV DNA testing have problems with low sensitivity, poor repeatability, high false positives and false negatives, which are difficult to accurately reflect the persistent infection status of HPV and its carcinogenic potential, affecting the accuracy and clinical management of screening.

Method used

The active HPV18 type E6 recombinant protein was developed based on prokaryotic expression technology, and highly bound monoclonal antibody combinations (5G3 and 2C7) were screened out. The HPV18 type E6 protein was specifically detected using a dual-antibody sandwich detection method and a biotin-avidin amplification system.

Benefits of technology

High specificity and high sensitivity detection of HPV18 type E6 protein can be achieved, which can quickly and accurately identify HPV18 infection in cervical shedding cells, reduce false positive results, improve the specificity and clinical practicality of cervical cancer screening, and support the risk assessment of cervical precancerous lesions and vaccine development.

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Abstract

The present invention relates to the field of biological detection technology, and in particular to a monoclonal antibody combination and application for the detection of HPV18 type E6 protein. The provided combination consists of 5G3 and 2C7, and the amino acid sequences of the complementary determining regions of the heavy chain and light chain variable regions are clear, as shown in SEQ ID NO.1-12, respectively. The antibody combination has high specificity and sensitivity, with a minimum detection limit of up to 100 pg / ml, and does not cross-react with other HPV subtypes. The double-antibody sandwich ELISA and biotin-avidin amplification detection system constructed based on the combination significantly improves the signal intensity and detection accuracy, is suitable for the rapid detection of HPV18 type E6 protein in cervical exfoliated cell samples, and has application value in the early diagnosis of cervical cancer, risk stratification, vaccine development and efficacy evaluation.
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