title: Significance of "Not Detected but Amplified" Results by Real-Time PCR Method for HPV DNA Detection.
abstract: Human papillomavirus (HPV) infection is an important etiologic factor in cervical carcinogenesis. Various HPV DNA detection methods have been evaluated for clinicopathological level. For the specimens with normal cytological finding, discrepancies among the detection methods were frequently found and adequate interpretation can be difficult. 6,322 clinical specimens were submitted and evaluated for real-time PCR and Hybrid Capture 2 (HC2). 573 positive or "Not Detected but Amplified" (NDBA) specimens by real-time PCR were additionally tested using genetic analyzer. For the reliability of real-time PCR, 325 retests were performed. Optimal cut-off cycle threshold (CT) value was evaluated also. 78.7% of submitted specimens showed normal or nonspecific cytological finding. The distributions of HPV types by real-time PCR were not different between positive and NDBA cases. For positive cases by fragment analysis, concordance rates with real-time PCR and HC2 were 94.2% and 84.2%. In NDBA cases, fragment analysis and real-time PCR showed identical results in 77.0% and HC2 revealed 27.6% of concordance with fragment analysis. Optimal cut-offCTvalue was different for HPV types. NDBA results in real-time PCR should be regarded as equivocal, not negative. The adjustment of cut-offCTvalue for HPV types will be helpful for the appropriate result interpretation.
authors.affiliation: Department of Laboratory Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul 03080, Republic of Korea.
authors.forename: Taek Soo
authors.initials: TS
authors.lastname: Kim
authors.affiliation: Department of Laboratory Medicine, Seoul National University Bundang Hospital, 82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do 13620, Republic of Korea.
authors.forename: Mi Suk
authors.initials: MS
authors.lastname: Lim
authors.affiliation: Department of Laboratory Medicine, Seoul National University Bundang Hospital, 82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do 13620, Republic of Korea.
authors.forename: Yun Ji
authors.identifier: 0000-0001-9163-5017
authors.initials: YJ
authors.lastname: Hong
authors.affiliation: Department of Laboratory Medicine, Seoul National University Bundang Hospital, 82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do 13620, Republic of Korea.
authors.forename: Sang Mee
authors.initials: SM
authors.lastname: Hwang
authors.affiliation: Department of Laboratory Medicine, Seoul National University Bundang Hospital, 82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do 13620, Republic of Korea; Department of Laboratory Medicine, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul 03080, Republic of Korea.
authors.forename: Kyoung Un
authors.identifier: 0000-0002-2402-7633
authors.initials: KU
authors.lastname: Park
authors.affiliation: Department of Laboratory Medicine, Seoul National University Bundang Hospital, 82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do 13620, Republic of Korea; Department of Laboratory Medicine, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul 03080, Republic of Korea.
authors.forename: Junghan
authors.initials: J
authors.lastname: Song
authors.affiliation: Department of Laboratory Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul 03080, Republic of Korea; Department of Laboratory Medicine, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul 03080, Republic of Korea.
authors.forename: Eui-Chong
authors.initials: EC
authors.lastname: Kim
mesh_terms: D000328:Adult; D004279:DNA, Viral / Q000145:classification / Q000235:genetics* / Q000302:isolation & purification; D005260:Female; D005838:Genotype; D006801:Humans; D025202:Molecular Diagnostic Techniques; D065006:Papanicolaou Test; D027383:Papillomaviridae / Q000145:classification / Q000235:genetics* / Q000302:isolation & purification / Q000472:pathogenicity; D030361:Papillomavirus Infections / Q000175:diagnosis / Q000235:genetics* / Q000473:pathology / Q000821:virology; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000235:genetics* / Q000821:virology
chemical_list: D004279:DNA, Viral