1. Evaluation of TypeSeq, a Novel High-Throughput, Low-Cost, Next-Generation Sequencing-Based Assay for Detection of 51 Human Papillomavirus Genotypes.
- Author
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Wagner S, Roberson D, Boland J, Kreimer AR, Yeager M, Cullen M, Mirabello L, Dunn ST, Walker J, Zuna R, Porras C, Cortes B, Sampson J, Herrero R, Rodriguez AC, Quint W, Van Doorn LJ, Hildesheim A, Schiffman M, and Wentzensen N
- Subjects
- Adolescent, Adult, Aged, Aged, 80 and over, Costa Rica, Costs and Cost Analysis, Cross-Sectional Studies, Female, Genotyping Techniques economics, High-Throughput Nucleotide Sequencing economics, Humans, Middle Aged, Papillomaviridae genetics, Papillomavirus Infections prevention & control, Papillomavirus Infections virology, Papillomavirus Vaccines immunology, Uterine Cervical Neoplasms prevention & control, Uterine Cervical Neoplasms virology, Young Adult, Genotype, Genotyping Techniques methods, High-Throughput Nucleotide Sequencing methods, Papillomaviridae classification, Papillomaviridae isolation & purification, Papillomavirus Infections diagnosis, Uterine Cervical Neoplasms diagnosis
- Abstract
Background: Human papillomaviruses (HPV) cause over 500 000 cervical cancers each year, most of which occur in low-resource settings. Human papillomavirus genotyping is important to study natural history and vaccine efficacy. We evaluated TypeSeq, a novel, next-generation, sequencing-based assay that detects 51 HPV genotypes, in 2 large international epidemiologic studies., Methods: TypeSeq was evaluated in 2804 cervical specimens from the Study to Understand Cervical Cancer Endpoints and Early Determinants (SUCCEED) and in 2357 specimens from the Costa Rica Vaccine Trial (CVT). Positive agreement and risks of precancer for individual genotypes were calculated for TypeSeq in comparison to Linear Array (SUCCEED). In CVT, positive agreement and vaccine efficacy were calculated for TypeSeq and SPF10-LiPA., Results: We observed high overall and positive agreement for most genotypes between TypeSeq and Linear Array in SUCCEED and SPF10-LiPA in CVT. There was no significant difference in risk of precancer between TypeSeq and Linear Array in SUCCEED or in estimates of vaccine efficacy between TypeSeq and SPF10-LiPA in CVT., Conclusions: The agreement of TypeSeq with Linear Array and SPF10-LiPA, 2 well established standards for HPV genotyping, demonstrates its high accuracy. TypeSeq provides high-throughput, affordable HPV genotyping for world-wide studies of cervical precancer risk and of HPV vaccine efficacy., (© The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America.)
- Published
- 2019
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