Tricore Reference Laboratory, Albuquerque, New Mexico, USA.
Becton, Dickinson and Company, BD Life Sciences-Integrated Diagnostic Solutions, Sparks, Maryland, USA.
J Clin Microbiol. 2020 Dec 17;59(1). doi: 10.1128/JCM.02048-20.
The objective of this study was to determine the result reproducibility and performance of the BD Onclarity human papillomavirus (HPV) assay (Onclarity) on the BD Viper LT platform using both contrived and clinical specimens. Reproducibility was assessed in BD SurePath liquid-based cytology (LBC) medium (SurePath) using contrived panels (HPV genotype 16 [HPV16] positive, HPV18 positive, or HPV45 positive) or clinical specimens (HPV16, -18, -31, -33/58, -45, or -52 positive or HPV negative). In addition, specimens from 3,879 individuals from the Onclarity trial were aliquoted prior to or following cytology processing and tested for HPV. Finally, specimens were collected using either the Cervex-Brush or Cytobrush (or Cytobrush/spatula) for comparison of HPV results. Contrived specimens showed >95% concordance with the expected results, and pooled clinical specimens had standard deviations and coefficients of variation ranging from 0.87 to 1.86 and 2.9% to 5.6%, respectively. For precytology and postcytology aliquot analyses, specimens showed >98.0% overall agreement and mean differences in cycle threshold ( ) scores for HPV ranging from -0.07 to 0.31. Positivity rates were close between the Cervex-Brush and Cytobrush/spatula for all age groups tested. Onclarity results are reproducible and reliable, regardless of sample collection before or after cytology aliquoting. Onclarity performs well regardless of the method of specimen collection (Cervex-Brush or Cytobrush/spatula) for cervical cancer screening.
本研究旨在确定 BD Onclarity 人乳头瘤病毒（HPV）检测（Onclarity）在 BD Viper LT 平台上使用人工和临床标本的结果重现性和性能。使用人工面板（HPV16 阳性、HPV18 阳性或 HPV45 阳性）或临床标本（HPV16、-18、-31、-33/58、-45 或-52 阳性或 HPV 阴性）在 BD SurePath 液基细胞学（LBC）介质（SurePath）中评估重现性。此外，在 Onclarity 试验中，从 3879 个人的标本中在细胞学处理之前或之后进行等分，并进行 HPV 检测。最后，使用 Cervex-Brush 或 Cytobrush（或 Cytobrush/刮刀）收集标本，以比较 HPV 结果。人工标本与预期结果的一致性>95%，混合临床标本的标准偏差和变异系数分别为 0.87-1.86 和 2.9%-5.6%。对于前细胞学和后细胞学等分分析，标本总体一致性>98.0%，HPV 循环阈值（）评分的平均差异为-0.07-0.31。在所有测试的年龄组中，Cervex-Brush 和 Cytobrush/刮刀之间的阳性率都很接近。无论在细胞学等分之前还是之后收集样本，Onclarity 的结果都是可重现和可靠的。无论用于宫颈癌筛查的标本采集方法（Cervex-Brush 或 Cytobrush/刮刀）如何，Onclarity 的性能都很好。
