title: Comparison of HPV genotyping assays and Hybrid Capture 2 for detection of high-risk HPV in cervical specimens.
abstract: High-risk types of human papillomavirus (HR-HPV) are among the primary causes of cervical cancers. Hybrid Capture 2 (HC-II) (Digene, Gaithersburg, MD), which detects 13 HR-HPVs as a group, is the only HPV assay approved to date by the United States Food and Drug Administration. In Korea, several HPV genotyping assays are commercially available, including HPV RFMP (GeneMatrix Co., Seoul), HPVDNACHIP (Biomedlab Co., Seoul), and MyHPV Chip (Mygene Co., Seoul). We compared the results of these assays with those of HC-II. Among 553 residual samples of liquid-based Pap tests, a total of 435 (78.7%) were available for HPV assays. They were classified into four cytologic categories: normal, atypical squamous cells of undetermined significance (ASCUS), low-grade cervical squamous intraepithelial lesions (LSIL), and high grade SIL or carcinoma (HSIL+). Among these samples, 23.0%, 40.6%, 82.5%, 93.8% were HR-HPV positive by HC-II, respectively; 6.6%, 18.1%, 44.4%, 84.4%, by HPV RFMP, respectively; 5.7%, 24.5%, 54.0%, 84.4%, by HPVDNACHIP, respectively; and 6.6%, 11.6%, 42.9%, 84.4%, by MyHPV, respectively. Compared with HC-II, the concordance rates and kappa values were 70.6% and 0.421 for HPV RFMP; 75.4% and 0.514 for HPVDNACHIP; and 67.8% and 0.367 for MyHPV. The concordance rates and kappa values between genotyping assays were 85.1% and 0.644 for HPV RFMP and HPVDNACHIP; 83.4% and 0.574 for HPV RFMP and MyHPV Chip; and 82.8% and 0.579 for HPVDNACHIP and MyHPV Chip. In conclusion, compared with HC-II test, the genotyping tests showed more than fair concordance but lower sensitivity in the detection of HR-HPVs, limiting their usefulness as HR-HPV screening tools.
authors.affiliation: Department of Laboratory Medicine, College of Medicine, Inje University, Goyang, South Korea.
authors.forename: Tae Hyun
authors.initials: TH
authors.lastname: Um
authors.forename: Eun Hee
authors.initials: EH
authors.lastname: Lee
authors.forename: Hyun-Sook
authors.initials: HS
authors.lastname: Chi
authors.forename: Jong-Won
authors.initials: JW
authors.lastname: Kim
authors.forename: Young-Joon
authors.initials: YJ
authors.lastname: Hong
authors.forename: Young Joo
authors.initials: YJ
authors.lastname: Cha
mesh_terms: D001681:Biological Assay / Q000379:methods*; D002584:Cervix Uteri / Q000473:pathology / Q000821:virology*; D004279:DNA, Viral / Q000032:analysis / Q000235:genetics; D005260:Female; D005838:Genotype; D006801:Humans; D027383:Papillomaviridae / Q000235:genetics* / Q000302:isolation & purification*; D011933:Reagent Kits, Diagnostic; D012307:Risk Factors; D014626:Vaginal Smears / Q000379:methods*
chemical_list: D004279:DNA, Viral; D011933:Reagent Kits, Diagnostic