Ejegod Ditte, Bottari Fabio, Pedersen Helle, Sandri Maria Teresa, Bonde Jesper
Department of Pathology, Copenhagen University Hospital, Hvidovre, Denmark
Division of Laboratory Medicine, European Institute of Oncology, Milan, Italy.
J Clin Microbiol. 2016 Sep;54(9):2267-72. doi: 10.1128/JCM.00508-16. Epub 2016 Jun 15.
This study describes a validation of the BD Onclarity HPV (Onclarity) assay using the international guidelines for HPV test requirements for cervical cancer screening of women 30 years old and older using Danish SurePath screening samples. The clinical specificity (0.90, 95% confidence interval [CI] = 0.88 to 0.91) and sensitivity (0.97, 95% CI = 0.87 to 1.0) of the Onclarity assay were shown to be not inferior to the reference assay (specificity, 0.90 [95% CI = 0.88 to 0.92]; sensitivity, 0.98 [95% CI = 0.91 to 1.0]). The intralaboratory reproducibility of Onclarity was 97%, with a lower confidence bound of 96% (kappa value, 0.93). The interlaboratory agreement was 97%, with a lower confidence bound of 95% (kappa value, 0.92). The BD Onclarity HPV assay fulfills all the international guidelines for a new HPV test to be used in primarily screening. This is the first clinical validation of a new HPV assay using SurePath screening samples, and thus the Onclarity HPV assay is the first HPV assay to hold an international validation for both SurePath and ThinPrep.
本研究描述了使用丹麦SurePath筛查样本，依据国际指南对30岁及以上女性宫颈癌筛查的HPV检测要求，对BD Onclarity HPV（Onclarity）检测法进行的验证。结果显示，Onclarity检测法的临床特异性（0.90，95%置信区间[CI]=0.88至0.91）和敏感性（0.97，95%CI=0.87至1.0）不低于参考检测法（特异性为0.90[95%CI=0.88至0.92]；敏感性为0.98[95%CI=0.91至1.0]）。Onclarity检测法的实验室内重复性为97%，置信下限为96%（kappa值为0.93）。实验室间一致性为97%，置信下限为95%（kappa值为0.92）。BD Onclarity HPV检测法符合用于初次筛查的新型HPV检测的所有国际指南。这是首次使用SurePath筛查样本对新型HPV检测法进行临床验证，因此Onclarity HPV检测法是首个同时获得SurePath和ThinPrep国际验证的HPV检测法。
