Section of Infectious Disease, Louisiana State University Health Sciences Center, New Orleans, LA, USA.
Becton, Dickinson and Company, BD Life Sciences-Integrated Diagnostic Solutions, Sparks, MD, USA.
Expert Rev Mol Diagn. 2021 Mar;21(3):333-342. doi: 10.1080/14737159.2021.1894132. Epub 2021 Apr 14.
: Here we compare the performance of the high-throughput BD COR System (COR) to the Viper LT System (Viper) using the BD Onclarity HPV assay.: Remnant clinical specimens, contrived specimens in SurePath (BD) and PreservCyt (Hologic) media, and prospective clinical specimens in BD Cervical Brush Diluent (CBD) were tested. Outcomes included intra-laboratory agreement of Onclarity results on COR and inter-system agreement between COR and Viper.: Onclarity reproducibility on COR resulted in standard deviation and correlation of variation of Ct values ranging from 0.14 to 1.98 and 0.49% to 2.15%, respectively, for contrived specimens, and 0.9-3.08 and 2.89-9.21%, respectively, for clinical specimens. In the COR and Viper clinical agreement study, OPA for Onclarity ranged from 97.1%-98.9%, depending on the collection media type. PPA values for pooled, HPV(+) specimens at low positive (C), and moderate positive (3XC) target concentrations were ≥95.0% and 100%, respectively; PPA values associated with HPV 16, 18, 31, 45, 33/58, 52, 35/39/68, 51, and 56/59/66, individually, ranged from 93.8%-100%.: Onclarity performance on COR is equivalent to Viper, and is accurate and reproducible for detection of all high-risk HPV genotypes, with a throughput of 330 results from a single 8-hour shift.
我们使用 BD Onclarity HPV 检测试剂比较了高通量 BD COR 系统（COR）和 Viper LT 系统（Viper）的性能。我们检测了剩余的临床标本、SurePath（BD）和 PreservCyt（Hologic）介质中的模拟标本，以及 BD Cervical Brush Diluent（CBD）中的前瞻性临床标本。结果包括 COR 上 Onclarity 结果的实验室内一致性以及 COR 和 Viper 之间的系统间一致性。Onclarity 在 COR 上的重复性导致 Ct 值的变异标准差和相关性分别在模拟标本中从 0.14 到 1.98 和 0.49% 到 2.15%，在临床标本中分别从 0.9 到 3.08 和 2.89% 到 9.21%。在 COR 和 Viper 的临床一致性研究中，Onclarity 的 OPA 范围为 97.1%-98.9%，取决于收集介质的类型。在低阳性（C）和中度阳性（3XC）靶浓度下，HPV(+) 标本的 PPA 值均≥95.0%和 100%；与 HPV 16、18、31、45、33/58、52、35/39/68、51 和 56/59/66 分别相关的 PPA 值范围从 93.8%-100%。Onclarity 在 COR 上的性能与 Viper 相当，可准确且可重复地检测所有高危 HPV 基因型，单个 8 小时班次的通量为 330 个结果。
