Cervical cancer is still a leading lethal cancer and the third most common cancer among women worldwide, and the 6th most common in Korean women. Human papillomavirus (HPV) infection is a major cause of cervical cancers (>99%). The most important high risk HPV16 and HPV18 account for about 70% of all invasive cervical cancers worldwide.
In our country, different HPV DNA detection and genotyping kits have been established for diagnosing and monitoring HPV-related disease in clinical practice and for research, since 2004. Most of them target the highly conserved region of the HPV L1 gene. The genotyping assays usually differ in their analytical performances with regard to type-specific sensitivities and specificities. However, there was a lack of reference materials to standardize the methods for HPV genotyping.
The Korean CDC constructed candidate reference materials comprising 16 targets (HPV6, -11, -16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, and 68). They were composed of recombinant HPV DNA plasmids including the full-length L1 protein. We evaluated whether the candidate reference materials could be used as the reference for HPV detection and genotyping using quantitative real-time polymerase chain reaction. Our results suggest that these reference materials may provide useful standards for standardizing quality assurance for different HPV-typing assays and for proficiency testing in diagnostic laboratories.
We have twice done two similar studies. The first 2014-subject was the development of an external quality assurance (EQA) program for HPV genotyping, and the second 2015-subject was the practical usage of EQA program for HPV genotyping.