Godoy Luani R, El-Zein Mariam, Padalko Elizaveta, Verberckmoes Bo, Van Eenooghe Bodine, Vermandere Heleen, Dias Sónia, Gama Ana, Vega Crespo Bernardo, Neira Vivian Alejandra, Franco Eduardo L, Longatto-Filho Adhemar
Division of Cancer Epidemiology, McGill University, Montreal, Québec, Canada.
Molecular Oncology Research Center, Barretos Cancer Hospital, Barretos, São Paulo, Brazil.
J Clin Microbiol. 2025 Jul 9:e0020025. doi: 10.1128/jcm.00200-25.
Numerous molecular tests are available to detect human papillomavirus (HPV). We compared the analytical performance of cobas and Anyplex for detection of high-risk (HR) carcinogenic HPV genotypes, assessed the composition of HPV types (other than 16 and 18) that influenced cobas performance, and considered the impact of viral load on test performance. We used data from the Early Detection of Cervical Cancer in Hard-to-Reach Populations of Women Through Portable and Point-of-Care HPV Testing project, which involved collection (2019-2022) of cervicovaginal samples from 1,042 women aged 21-74 years in Belgium ( = 244), Portugal ( = 309), Brazil ( = 244), and Ecuador ( = 245). Samples were tested by cobas (provides individual results for HPV16 and HPV18 and a pooled result for 12 other HR-HPV types) and Anyplex (provides separate results for 14 HR-HPVs). We calculated HPV positivity by each test and compared performance between tests by calculating Cohen's kappa statistics. Based on 938 samples with complete data from both tests, positivity rates by cobas were 13.4%, 3.6%, 34.3%, and 45.3% for HPV16, HPV18, 12 pooled HR-HPVs, and any HR-HPV, respectively. Corresponding HPV positivity rates by Anyplex were 14.9%, 3.7%, 37.9%, and 50.0% for the same categories, respectively, with high concordance; kappa statistics were 0.90, 0.87, 0.82, and 0.85, respectively. Based on 355 samples that tested positive for at least 1 of the 12 pooled HR-HPVs, most types showed high agreement (80.9%-100.0%) between individual-Anyplex and pooled-cobas HPV results, except for HPV68 (61.3% agreement). Our findings suggest that the two commercial tests may have different performances, depending on the specific HPV types detected, emphasizing the need for continued research on conditions that may affect these tests, especially for less common or less studied HPV types.IMPORTANCEThis study compared two commercial tests-cobas and Anyplex-for detecting high-risk HPV types in women undergoing routine cervical cancer screening or referred for colposcopy. Both tests provide separate results for HPV16 and HPV18, but Anyplex also identifies the remaining 12 high-risk HPV types individually, while cobas groups them together. Overall, we found a high level of agreement between the two tests, supporting their use in clinical practice. However, differences in detecting certain HPV types, particularly those that are less common or less studied, emphasize the importance of choosing the right test. As more countries switch to HPV-based cervical cancer screening, using tests that provide detailed results could help improve risk assessment and optimize patient care.
有多种分子检测方法可用于检测人乳头瘤病毒（HPV）。我们比较了 cobas 和 Anyplex 在检测高危（HR）致癌性 HPV 基因型方面的分析性能，评估了影响 cobas 性能的 HPV 类型（16 和 18 型除外）的组成，并考虑了病毒载量对检测性能的影响。我们使用了通过便携式和即时护理 HPV 检测在难以触及的女性人群中早期检测宫颈癌项目的数据，该项目涉及在 2019 年至 2022 年期间从比利时（n = 244）、葡萄牙（n = 309）、巴西（n = 244）和厄瓜多尔（n = 245）的 1042 名年龄在 21 - 74 岁的女性中收集宫颈阴道样本。样本通过 cobas（提供 HPV16 和 HPV18 的单独结果以及其他 12 种 HR - HPV 类型的汇总结果）和 Anyplex（提供 14 种 HR - HPV 的单独结果）进行检测。我们计算了每种检测方法的 HPV 阳性率，并通过计算 Cohen's kappa 统计量来比较不同检测方法之间的性能。基于来自两种检测方法都有完整数据的 938 个样本，cobas 检测的 HPV16、HPV18、12 种汇总 HR - HPV 和任何 HR - HPV 的阳性率分别为 13.4%、3.6%、34.3%和 45.3%。Anyplex 检测相同类别对应的 HPV 阳性率分别为 14.9%、3.7%、37.9%和 50.0%，一致性较高；kappa 统计量分别为 0.90、0.87、0.82 和 0.85。基于 355 个至少对 12 种汇总 HR - HPV 中的 1 种检测呈阳性的样本，除了 HPV68（一致性为 61.3%）外，大多数类型在 Anyplex 单独检测和 cobas 汇总检测的 HPV 结果之间显示出高度一致性（80.9% - 100.0%）。我们的研究结果表明，这两种商业检测方法可能具有不同的性能，具体取决于所检测的特定 HPV 类型，强调需要继续研究可能影响这些检测的条件，特别是对于不太常见或研究较少的 HPV 类型。重要性本研究比较了两种商业检测方法——cobas 和 Anyplex——在对接受常规宫颈癌筛查或转诊进行阴道镜检查的女性中检测高危 HPV 类型的情况。两种检测方法都提供 HPV16 和 HPV18 的单独结果，但 Anyplex 还能分别识别其余 12 种高危 HPV 类型，而 cobas 将它们归为一组。总体而言我们发现两种检测方法之间的一致性较高，支持它们在临床实践中的应用。然而，在检测某些 HPV 类型方面存在差异，特别是那些不太常见或研究较少的类型，这强调了选择合适检测方法的重要性。随着越来越多的国家转向基于 HPV 的宫颈癌筛查，使用能提供详细结果的检测方法有助于改善风险评估并优化患者护理。
