American journal of clinical pathology · 2014
Development and validation of a new HPV genotyping assay based on next-generation sequencing.
СтатьяПоддержка исследования: вне правительства СШАВалидационное исследованиеНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Yi Xin, Zou Jing, Xu Jiajia, Liu Tao, Liu Tengfei, Hua Sang, Xi Feng, Nie Xifang, Ye Lili, Luo Yufen, Xu Lin, Du Hui, Wu Ruifang, Yang Ling, Liu Ren, Yang Bin, Wang Jian, Belinson Jerome L
Аннотация
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.
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.
Предметные рубрики MeSH
AlphapapillomavirusCarcinoma, Squamous CellDNA, ViralEarly Detection of CancerFemaleGenotyping TechniquesHigh-Throughput Nucleotide SequencingHuman Papillomavirus DNA TestsHumansMultiplex Polymerase Chain ReactionPapillomavirus InfectionsROC CurveSensitivity and SpecificitySpecimen HandlingSpectrometry, Mass, Matrix-Assisted Laser Desorption-IonizationUterine Cervical NeoplasmsVaginal SmearsUterine Cervical Dysplasia