Min-Jung Kwon1, Kyoung Ho Roh2, Hyosoon Park1, Hee-Yeon Woo3. 1. Department of Laboratory Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea. 2. Seegene Institute of Life Sciences, Seoul, South Korea. 3. Department of Laboratory Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea. Electronic address: drwhy@hanmail.net.
Abstract
BACKGROUND: Human papillomavirus (HPV) testing is an important part of cervical cancer screening and management of women with abnormal cytology results. The Hybrid Capture 2 (HC2) has been recommended for use as a reference test. OBJECTIVE: To evaluate a new real-time PCR assay (Anyplex II HPV28) for detecting high risk (HR) HPV and to compare it to the HC2. In addition, we compared the genotyping results of the Anyplex II HPV28 to those of sequencing analysis. STUDY DESIGN: A total of 1114 cervical swab specimens were consecutively obtained from a single healthcare center. We submitted all specimens for HPV detection with Anyplex II HPV28 and HC2, then analyzed the discordant results using multiplex PCR followed by direct sequencing. RESULTS: HC2 detected 72 (6.5%) cases with HR HPV, while Anyplex II HPV28 identified 138 (12.4%) cases. The overall agreement rate was 91.4% (1018/1114) of cases. Discordant results between these two assays were observed in 96 cases; 15 were positive only by HC2, and 81 were positive only by Anyplex II HPV28. Sequencing analyses performed in 80 cases of discordant results revealed 11 false-positive, and 67 false-negative results using HC2 tests and two false-positive results using Anyplex II HPV28. CONCLUSIONS: The Anyplex II HPV28 assay is analytically more sensitive in the detection of the 13 HR types represented by the HC2 assay and exhibited a higher concordance with comprehensive genotyping based on the sequencing analysis, and it could be used as a laboratory testing method for identifying HPV genotypes.
BACKGROUND:Human papillomavirus (HPV) testing is an important part of cervical cancer screening and management of women with abnormal cytology results. The Hybrid Capture 2 (HC2) has been recommended for use as a reference test. OBJECTIVE: To evaluate a new real-time PCR assay (Anyplex II HPV28) for detecting high risk (HR) HPV and to compare it to the HC2. In addition, we compared the genotyping results of the Anyplex II HPV28 to those of sequencing analysis. STUDY DESIGN: A total of 1114 cervical swab specimens were consecutively obtained from a single healthcare center. We submitted all specimens for HPV detection with Anyplex II HPV28 and HC2, then analyzed the discordant results using multiplex PCR followed by direct sequencing. RESULTS: HC2 detected 72 (6.5%) cases with HR HPV, while Anyplex II HPV28 identified 138 (12.4%) cases. The overall agreement rate was 91.4% (1018/1114) of cases. Discordant results between these two assays were observed in 96 cases; 15 were positive only by HC2, and 81 were positive only by Anyplex II HPV28. Sequencing analyses performed in 80 cases of discordant results revealed 11 false-positive, and 67 false-negative results using HC2 tests and two false-positive results using Anyplex II HPV28. CONCLUSIONS: The Anyplex II HPV28 assay is analytically more sensitive in the detection of the 13 HR types represented by the HC2 assay and exhibited a higher concordance with comprehensive genotyping based on the sequencing analysis, and it could be used as a laboratory testing method for identifying HPV genotypes.
Authors: A M Cornall; M Poljak; S M Garland; S Phillips; J H Tan; D A Machalek; M A Quinn; S N Tabrizi Journal: Eur J Clin Microbiol Infect Dis Date: 2016-11-08 Impact factor: 3.267
Authors: Jeong Eun Lee; Yong-Moon Lee; In-Ock Seong; Min-Woong Kang; Choong Sik Lee; Kyung-Hee Kim Journal: Osong Public Health Res Perspect Date: 2016-10-21
Authors: Taekmin Kwon; Kyung Hyun Moon; Sung-Hak Yang; Min Cheol Roh; Sang Hoon Lee; Je Won Kim; In Kyu Kim; Kyoung Ho Roh; Sungchan Park Journal: J Korean Med Sci Date: 2016-02-04 Impact factor: 2.153