GT-Digital Human Papillomavirus (HPV) Assay Panel v1.0 for the Bio-Rad QX600™ Droplet Digital™ PCR System
Description
(Cat# 101070)
GT-Digital Human Papillomavirus (HPV) Assay Panel v1.0 for the Bio-Rad QX600™ Droplet Digital™ PCR System is a molecular reagent kit consisting of all primers, probes, and controls necessary for detection of high-risk HPV viral DNA subtypes, including HPV 16 (FAM), HPV 18 (ROX), HPV 45 (HEX) and HPV 31 (Cy5). This assay also utilizes Polypyrimidine Tract Binding Protein (PTBT, Cy5.5) as a housekeeping gene, allowing the user to normalize HPV copies per diploid human genome. This assay allows identification of HPV infection in cell-free DNA (cfDNA) extracted from human plasma. Assay solutions and appropriate controls are provided to ensure accurate quantification of all targets. When used in conjunction with the Bio-Rad QX600™ Digital PCR System, this kit facilitates reliable HPV infection detection, monitoring of HPV infection progression, and public health surveillance efforts. Contains enough material for 50 reactions.
IMPORTANT! Human Papillomavirus (HPV) Assay Panel has been validated on Human cfDNA plasma extracts. This panel can work on other matrixes, however further optimization and validation is required by the user.
More Information
Clinical Relevance of Target Coverage
Human Papillomavirus (HPV) is responsible for the majority of virus-related cancers worldwide. Persistent infection with high-risk HPV genotypes can lead to cervical, anal, penile, vulvar, vaginal, and oropharyngeal cancers. Globally, HPV is estimated to cause almost all cervical cancers, over 90% of anal cancers, 70% of vaginal and vulvar cancers, 63% of penile cancers, and 70% of oropharyngeal (throat) cancers. (National Cancer Institute. HPV and Cancer. U.S. Department of Health and Human Services, updated May 9 2025. https://www.cancer.gov/about-cancer/causes-prevention/risk/infectious-agents/hpv-and-cancer)
Overall, HPV is responsible for about 4.5% of all cancers worldwide, making it one of the most significant infectious contributors to cancer burden.
Estimated Coverage of High-Risk HPV Cases
The GT-Digital® Human Papillomavirus (HPV) Assay Panel v1.0 (RUO) targets the four most clinically significant high-risk HPV genotypes, HPV 16, 18, 31, and 45, which together account for approximately 80% of all HPV-related cancers worldwide. HPV 16 and 18 are responsible for the majority of cervical and other anogenital cancers, while HPV 31 and 45 contribute to additional high-risk cases, including adenocarcinomas. By focusing on these dominant oncogenic strains, this multiplexed assay panel delivers highly relevant data for cancer research through cfDNA-based monitoring and offers a powerful tool for understanding and tracking HPV’s role in disease progression.
Citations from epidemiological studies (such as In vivo, 2015; de Sanjosé et al., Lancet Oncology, 2010; ICO/IARC HPV Information Centre, 2024 updates)
The GT Molecular HPV Assay Panel targets the primary oncogenic genotypes responsible for the majority of high-risk HPV infections and HPV-attributable cancers.