title: Development of reference materials to detect 15 different human papillomavirus genotypes.
abstract: Accurate human papillomavirus (HPV) typing is essential for evaluating and monitoring HPV vaccines in cervical cancer screening and in epidemiological surveys. In our country, different HPV DNA detection and genotyping methodologies have been established for diagnosing and monitoring HPV-related disease in clinical practice and for research. However, there is a lack of reference materials to standardize the methods for HPV detection and genotyping. In this study, we constructed candidate reference materials comprising 15 targets (13 types of high-risk HPV, two types of low-risk HPV). 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. Standard curves for the wide linear range (10(1)-10(6)copies/μL) produced high correlation regression coefficient R(2) of 0.99. The reaction efficiencies were 96.3% to 101.2% for the standard curves, indicating highly efficient reactions. Specific genotypes were detected in single or multiple mixed samples. 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.
authors.affiliation: Division of AIDS, Center for Immunology and Pathology, Korea National Institute of Health, Chungcheong-Bukdo, Republic of Korea.
authors.forename: Jee Eun
authors.initials: JE
authors.lastname: Rhee
authors.affiliation: Office of Genome Research and Development, Cheil General Hospital & Women's Healthcare Center, College of Medicine, Kwandong University, Seoul, Republic of Korea.
authors.forename: Young Soon
authors.initials: YS
authors.lastname: Kang
authors.affiliation: Office of Genome Research and Development, Cheil General Hospital & Women's Healthcare Center, College of Medicine, Kwandong University, Seoul, Republic of Korea.
authors.forename: Hyun Hee
authors.initials: HH
authors.lastname: Seo
authors.affiliation: Division of AIDS, Center for Immunology and Pathology, Korea National Institute of Health, Chungcheong-Bukdo, Republic of Korea.
authors.forename: Ju-yeon
authors.initials: JY
authors.lastname: Choi
authors.affiliation: Division of AIDS, Center for Immunology and Pathology, Korea National Institute of Health, Chungcheong-Bukdo, Republic of Korea.
authors.forename: Mee-Kyung
authors.initials: MK
authors.lastname: Kee
authors.affiliation: Department of Obstetrics and Gynecology, Cheil General Hospital & Women's Healthcare Center, College of Medicine, Kwandong University, Seoul, Republic of Korea.
authors.forename: Tae-Jin
authors.initials: TJ
authors.lastname: Kim
authors.affiliation: Department of Pathology, Cheil General Hospital & Women's Healthcare Center, College of Medicine, Kwandong University, Seoul, Republic of Korea. Electronic address: srh7661@naver.com.
authors.forename: Sung Ran
authors.initials: SR
authors.lastname: Hong
authors.affiliation: Division of AIDS, Center for Immunology and Pathology, Korea National Institute of Health, Chungcheong-Bukdo, Republic of Korea. Electronic address: sungskim@korea.kr.
authors.forename: Sung Soon
authors.initials: SS
authors.lastname: Kim
mesh_terms: D019411:Clinical Laboratory Techniques; D004274:DNA, Recombinant / Q000235:genetics; D060005:Genotyping Techniques / Q000592:standards*; D006801:Humans; D027383:Papillomaviridae / Q000235:genetics*; D012015:Reference Standards; D015203:Reproducibility of Results
chemical_list: D004274:DNA, Recombinant
keywords: Genotype; Human papillomavirus; Proficiency; Reference material