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- Title
Development and Validation of a New HPV Genotyping Assay Based on Next-Generation Sequencing.
- Authors
Xin Yi; Jing Zou; Jiajia Xu; Tao Liu; Tengfei Liu; Sang Hua; Feng Xi; Xifang Nie; Lili Ye; Yufen Luo; Lin Xu; Hui Du; Ruifang Wu; Ling Yang; Ren Liu; Bin Yang; Jian Wang; Belinson, Jerome L.
- Abstract
Objectives: We developed a new human papillomavirus (HPV) genotyping assay based on multiplex polymerase chain reaction and next-generation sequencing (NGS) methods for large-scale cervical cancer screening. Methods: We first trained the assay on 1,170 self-collected samples, balancing the cutoff points for high-risk types. Then using 4,262 separate self-collected specimens, we compared concordance, sensitivity, and specificity for cervical intraepithelial neoplasia type 2 (CIN2) or higher and CIN type 3 (CIN3) or higher of the HPV sequencing assay with that of Hybrid Capture 2 (HC2) direct samples and matrix-assisted laser desorption/ionization time-of-flight mass spectrometry assay self-samples. Results: All assays had a good agreement. The sensitivity for CIN2 or higher and CIN3 or higher of the self-sampling specimens tested with the sequencing assay run on both MiSeq and Ion Torrent Personal Genome Machine sequencer was similar to that of direct-sampling specimens tested with HC2 (P > .05), but the specificity of the sequencing assay for CIN2 or higher and CIN3 or higher was significantly higher than that of HC2 (P < .01). Conclusions: This population-based study has demonstrated the applicability of a new NGS high-risk HPV assay for primary cervical cancer screening based on self-collection.
- Subjects
POLYMERASE chain reaction; CERVICAL cancer diagnosis; CERVICAL intraepithelial neoplasia; NUCLEOTIDE sequence
- Publication
American Journal of Clinical Pathology, 2014, Vol 141, Issue 6, p796
- ISSN
0002-9173
- Publication type
Article
- DOI
10.1309/AJCP9P2KJSXEKCJB