BD Onclarity™ HPV检测法对SurePath样本中CIN2+病变检测的临床和分析性能
Clinical and analytical performance of the BD Onclarity™ HPV assay for detection of CIN2+ lesions on SurePath samples.
作者信息
Ejegod Ditte Møller, Junge Jette, Franzmann Maria, Kirschner Benny, Bottari Fabio, Sideri Mario, Sandri Maria-Teresa, Bonde Jesper
机构信息
Copenhagen University Hospital, Department of Pathology, Hvidovre, Denmark.
Copenhagen University Hospital, Department of Gynecology, Hvidovre, Denmark.
出版信息
Papillomavirus Res. 2016 Dec;2:31-37. doi: 10.1016/j.pvr.2016.01.003. Epub 2016 Mar 2.
BACKGROUND
The novel BD Onclarity HPV assay (Onclarity) on the BD Viper™ LT system (BD Diagnostics, Sparks, MD), detects E6/E7 DNA from 13 high-risk HPV genotypes and HPV66. We compared the analytical and clinical performance of the Onclarity Assay to that of Hybrid Capture 2 and LINEAR ARRAY using adjudicated histological outcomes from Danish women referred for colposcopy.
METHODS
276 women from Copenhagen, Denmark were referred for colposcopy with abnormal cytology and/or a positive HPV test. Two samples for HPV analysis were taken in BD SurePath™ and in the BD cervical brush diluent (CBD) media. ClinicalTrial gov. identifier: NCT01671462, Ethical Approval: H-4-2012-070.
RESULTS
Histology was normal in 84 (31%) women, 70 (26%) had CIN1, 47 (17%) CIN2, and 68 (25%) had CIN3. The Onclarity assay detected 67 out of 68 (99%) ≥CIN3 and 113/115 (98%) ≥CIN2. The specificities for <CIN2 were 21%, 17%, and 22%, for HC2, Onclarity and LA, respectively.
CONCLUSION
Overall, the Onclarity HPV assay performed well on SurePath LBC and CBD media, with clinical sensitivity and specificity matching those of HC2 and LA.
背景
BD Viper™ LT系统（BD诊断公司，美国马里兰州斯帕克斯）上的新型BD Onclarity HPV检测法（Onclarity）可检测13种高危型人乳头瘤病毒（HPV）基因型和HPV66的E6/E7 DNA。我们使用丹麦接受阴道镜检查的女性的经判定的组织学结果，比较了Onclarity检测法与杂交捕获2代检测法（HC2）和线性阵列检测法（LA）的分析性能和临床性能。
方法
来自丹麦哥本哈根的276名女性因细胞学异常和/或HPV检测呈阳性而接受阴道镜检查。在BD SurePath™和BD宫颈刷稀释液（CBD）培养基中采集两份用于HPV分析的样本。临床试验注册号：NCT01671462，伦理批准号：H-4-2012-070。
结果
84名（31%）女性组织学正常，70名（26%）患有CIN1，47名（17%）患有CIN2，68名（25%）患有CIN3。Onclarity检测法在68例（99%）≥CIN3病例中检测出67例，在115例（98%）≥CIN2病例中检测出113例。对于<CIN2，HC2、Onclarity和LA的特异性分别为21%、17%和22%。
结论
总体而言，Onclarity HPV检测法在SurePath液基薄层制片（LBC）和CBD培养基上表现良好，临床敏感性和特异性与HC2和LA相当。
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