Division of High-Consequence Pathogens and Pathology, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.
Division of High-Consequence Pathogens and Pathology, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.
J Mol Diagn. 2023 Apr;25(4):211-216. doi: 10.1016/j.jmoldx.2022.12.006. Epub 2023 Jan 21.
Prophylactic human papillomavirus (HPV) vaccines are recommended for prevention of HPV-associated cancers. Type-specific detection of HPV in formalin-fixed, paraffin-embedded (FFPE) tissues retrieved from diagnostic pathology laboratories is important in monitoring the impact of HPV vaccines. However, few typing assays have been validated for testing FFPE samples. Results of the Novaplex II HPV28 Detection (Novaplex) assay were compared with those from the reference assay (Linear Array with reflex Line Probe Assay) on 708 FFPE samples from cervical lesions. Novaplex showed high type-specific concordance with the reference method for HPV16/18, 9 types targeted by the Gardasil 9 vaccine, 14 high-risk types, and 21 types covered by comparison assays. The rate of inadequate samples was low in both approaches (reference, 3.4%; Novaplex, 1.7%). The proportion of discrepant types was less than 3.5% and positive concordance was greater than 75.0%. Furthermore, the type-specific positive agreement (92.0% to 98.0%), negative agreement (96.0% to 99.0%), and accuracy (97.0% to 99.0%) was high. Cohen's κ ranged from 0.86 to 0.89, indicating excellent agreement between Novaplex and reference assays. The results show that Novaplex is a suitable method for detection of HPV in FFPE tissues.
预防性人乳头瘤病毒（HPV）疫苗推荐用于预防 HPV 相关癌症。在监测 HPV 疫苗的影响方面，从诊断病理学实验室获取的福尔马林固定、石蜡包埋（FFPE）组织中 HPV 的型特异性检测非常重要。然而，用于检测 FFPE 样本的 HPV 分型检测方法很少得到验证。在 708 例来自宫颈病变的 FFPE 样本中，比较了 Novaplex II HPV28 检测（Novaplex）试剂盒与参考方法（线性阵列与反射线探针杂交试验）的结果。Novaplex 与参考方法对 HPV16/18、Gardasil 9 疫苗针对的 9 种类型、14 种高危型和比较检测涵盖的 21 种类型的 HPV 具有高度的型特异性一致性。两种方法的样本不足率均较低（参考方法为 3.4%；Novaplex 为 1.7%）。不一致类型的比例小于 3.5%，阳性符合率大于 75.0%。此外，HPV 型特异性阳性符合率（92.0%至 98.0%）、阴性符合率（96.0%至 99.0%）和准确性（97.0%至 99.0%）均较高。Cohen's κ 范围为 0.86 至 0.89，表明 Novaplex 与参考方法之间具有极好的一致性。结果表明，Novaplex 是一种适用于检测 FFPE 组织中 HPV 的方法。
