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首页> 外文期刊>Journal of Clinical Microbiology >High-Risk Human Papillomavirus (hrHPV) E6/E7 mRNA Testing by PreTect HPV-Proofer for Detection of Cervical High-Grade Intraepithelial Neoplasia and Cancer among hrHPV DNA-Positive Women with Normal Cytology
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High-Risk Human Papillomavirus (hrHPV) E6/E7 mRNA Testing by PreTect HPV-Proofer for Detection of Cervical High-Grade Intraepithelial Neoplasia and Cancer among hrHPV DNA-Positive Women with Normal Cytology

机译：高风险人乳头瘤病毒（hrHPV）E6 / E7 mRNA测试通过PreTect HPV校对剂检测hrHPV DNA阳性且细胞学正常的女性宫颈高级别上皮内瘤变和癌症

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Our aim was to investigate whether high-risk HPV (hrHPV) mRNA detection by PreTect HPV-Proofer can be used to stratify hrHPV DNA-positive women of different cytology classes for risk of high-grade cervical intraepithelial neoplasia or worse (cervical precancer or cancer, i.e., cervical intraepithelial neoplasia grade 2 or higher [≥CIN2]). A total of 375 women participating in population-based screening, with a GP5+/6+-PCR hrHPV DNA-positive cervical scrape with normal cytology (n = 202), borderline or mild dyskaryosis (BMD) (n = 88), or moderate dyskaryosis or worse (>BMD) (n = 85), were enrolled. Cervical scrapes were additionally subjected to HPV16/18/31/33/45 E6/E7 mRNA analysis by PreTect HPV-Proofer (mRNA test). Referral and follow-up policies were based on cytology, hrHPV DNA, and mRNA testing. The primary study endpoint was the number of ≥CIN2 detected within 3 years of follow-up. The mRNA positivity increased with the severity of cytological abnormality, ranging from 32% (64/202) in hrHPV DNA-positive women with normal cytology to 47% (41/88) in BMD and 68% (58/85) in >BMD groups (P < 0.01). Women with ≥CIN2 were more likely to test positive by mRNA test (63%) than women without evidence of ≥CIN2 (32%; P < 0.01). A positive mRNA test result conferred an increased ≥CIN2 risk in hrHPV DNA-positive women with normal cytology, i.e., 0.55 (95% confidence interval [95% CI], 0.34 to 0.76) in mRNA-positive versus 0.20 (95% CI, 0.07 to 0.33) in mRNA-negative women. In hrHPV DNA-positive women with BMD or >BMD, the result of the mRNA test did not influence the ≥CIN2 risk. In conclusion, mRNA testing by PreTect HPV-Proofer might be of value to select hrHPV DNA-positive women with normal cytology in need of immediate referral for colposcopy.
机译：我们的目的是研究通过PreTect HPV-Proofer检测高危HPV（hrHPV）mRNA是否可用于对不同细胞学类型的hrHPV DNA阳性女性进行分层，以评估其是否患有高级别宫颈上皮内瘤变或更严重（宫颈癌或癌症）的风险即宫颈上皮内瘤变2级或更高[≥CIN2]。共有375名妇女参加了基于人群的筛查，其GP5 + / 6 + -PCR hrHPV DNA阳性宫颈刮擦细胞学检查正常（ n = 202），处于边缘性或轻度旋后病（BMD）（ n = 88），或中度旋律或更严重（> BMD）（ n = 85）。通过PreTect HPV-Proofer（mRNA测试）对宫颈小碎片进行HPV16 / 18/31/33/45 E6 / E7 mRNA分析。转诊和随访政策基于细胞学，hrHPV DNA和mRNA检测。主要研究终点为随访3年内检测到的≥CIN2数量。 mRNA阳性率随细胞学异常严重程度的增加而增加，范围从细胞学正常的hrHPV DNA阳性女性中占32％（64/202），到BMD中占47％（41/88），> BMD中占68％（58/85）。组（ P <0.01）。 CIN2≥的女性比无CIN2的女性（32％; P <0.01）更有可能通过mRNA检测呈阳性（63％）。如果细胞学检查正常的hrHPV DNA阳性女性的mRNA检测结果阳性，≥CIN2风险增加，即mRNA阳性的0.55（95％置信区间[95％CI]，0.34至0.76）与0.20（95％CI， 0.07至0.33）在mRNA阴性的女性中。在具有BMD或> BMD的hrHPV DNA阳性女性中，mRNA测试的结果不影响≥CIN2的风险。总之，通过PreTect HPV-Proofer进行mRNA检测对于选择细胞学正常，需要立即转诊进行阴道镜检查的hrHPV DNA阳性的女性可能是有价值的。

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