Development and validation of a multiplex qPCR method for identification of high-risk genotypes of human papillomavirus.

IF 3.1 2区医学 Q3 IMMUNOLOGY

Infectious Agents and Cancer Pub Date : 2025-03-07 DOI:10.1186/s13027-024-00633-z

Ali Mohammadi, Ehsan Lotfi, Fatemeh Karamali, Fereshteh Golab, Mahmood Barati

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引用次数: 0

Abstract

Cervical cancer is a significant public health concern, disproportionately affecting women in less developed regions due to limited access to screening and vaccination programs. Despite advancements in cervical cancer prevention and treatment, there remains a need for efficient and cost-effective diagnostic tools. This study aimed to develop a multiplex real-time PCR assay to rapidly and accurately identify 15 human papillomavirus (HPV) genotypes.The primary objective was to design a screening method capable of simultaneously detecting HPV types 16 and 18, which account for over 70% of cervical cancers, as well as other clinically relevant high-risk and probable/possible high-risk. To validate the assay's performance, we compared its results with those obtained using the commercially available INNO-LiPA HPV Genotyping Extra II Assay kit (FujireBio, Tokyo, Japan). The developed assay successfully identified 15 HPV genotypes in a single reaction. Analysis of 150 positive and 40 negative clinical samples demonstrated excellent concordance between the two assays. The in-house real-time PCR test exhibited a clinical sensitivity of 98% and a clinical specificity of 100%, indicating its reliability and accuracy for HPV genotyping. The multiplex real-time PCR assay is a cost-effective and efficient tool for HPV screening, detecting multiple genotypes simultaneously. It enhances screening efficiency and accuracy, improving early detection and management of HPV-related diseases.

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来源期刊

Infectious Agents and Cancer ONCOLOGY-IMMUNOLOGY

CiteScore

5.80

自引率

2.70%

发文量

期刊介绍： Infectious Agents and Cancer is an open access, peer-reviewed online journal that encompasses all aspects of basic, clinical, epidemiological and translational research providing an insight into the association between chronic infections and cancer. The journal welcomes submissions in the pathogen-related cancer areas and other related topics, in particular: • HPV and anogenital cancers, as well as head and neck cancers; • EBV and Burkitt lymphoma; • HCV/HBV and hepatocellular carcinoma as well as lymphoproliferative diseases; • HHV8 and Kaposi sarcoma; • HTLV and leukemia; • Cancers in Low- and Middle-income countries. The link between infection and cancer has become well established over the past 50 years, and infection-associated cancer contribute up to 16% of cancers in developed countries and 33% in less developed countries. Preventive vaccines have been developed for only two cancer-causing viruses, highlighting both the opportunity to prevent infection-associated cancers by vaccination and the gaps that remain before vaccines can be developed for other cancer-causing agents. These gaps are due to incomplete understanding of the basic biology, natural history, epidemiology of many of the pathogens that cause cancer, the mechanisms they exploit to cause cancer, and how to interrupt progression to cancer in human populations. Early diagnosis or identification of lesions at high risk of progression represent the current most critical research area of the field supported by recent advances in genomics and proteomics technologies.