Huang Shihai, Gentil Luciana Girotto, Schmidt Colleen, Cullum Richard, Zhang Yan, Nelson Kevin, Lucic Danijela, Abravaya Klara
Molecular Diagnostics of Abbott, Des Plaines, Illinois, USA.
Abbott Laboratories de Chile Ltda., Santiago, Chile.
Microbiol Spectr. 2025 Sep 2;13(9):e0058925. doi: 10.1128/spectrum.00589-25. Epub 2025 Aug 6.
Primary high-risk human papillomavirus (HPV) testing is recommended for cervical cancer screening due to its sensitivity and high negative predictive value. Most of the cervical cancers are caused by HPV16 and HPV18, and their presence has been used to guide patient management. Here, we compared the clinical performance of the Alinity m HR HPV, cobas 4800 HPV, and cobas 6800 HPV assays in the context of cervical cancer screening. Clinical sensitivity and specificity were evaluated with 125 ≥CIN3 (cervical intraepithelial neoplasia grade 3) cases and 244 controls (≤CIN1). The genotype agreements between the assays were also evaluated for the case and control groups. The clinical sensitivities were 96.0% for Alinity m and cobas 6800 assays, and 95.2% for cobas 4800 assay. The clinical specificities observed were 67.6%, 68.0%, and 68.4% for Alinity m, cobas 6800, and cobas 4800 assays, respectively. Overall, the three HPV assays demonstrated similar clinical performance. In the ≥CIN3 group, genotype-specific positive agreement was ≥98.4% between Alinity m and cobas 4800 assays, and ≥85.7% between cobas 6800 and cobas 4800 assays. In the ≤CIN1 group, overall positive agreement among the three assays was ≥94.8%. This study showed similar clinical sensitivity and specificity for Alinity m HR HPV, cobas 4800 HPV, and cobas 6800 HPV assays. Alinity m was more specific in detecting HPV16 and HPV18, which could reduce unnecessary immediate referrals of women to colposcopy.IMPORTANCEThis study provides evidence that the Alinity m HR human papillomavirus (HPV) assay has similar clinical performance in comparison with the cobas 4800 HPV and cobas 6800 HPV, two widely used tests. Validation of HPV assays in a clinical setting is crucial to ensure that they can provide a balanced sensitivity and specificity for detecting high-grade cervical intraepithelial neoplasia, potentially improving patient management by enabling proper follow-up or treatment and avoiding unnecessary procedures.
由于其敏感性和高阴性预测价值，原发性高危型人乳头瘤病毒（HPV）检测被推荐用于宫颈癌筛查。大多数宫颈癌由HPV16和HPV18引起，它们的存在已被用于指导患者管理。在此，我们比较了Alinity m HR HPV检测、cobas 4800 HPV检测和cobas 6800 HPV检测在宫颈癌筛查中的临床性能。对125例≥CIN3（宫颈上皮内瘤变3级）病例和244例对照（≤CIN1）进行了临床敏感性和特异性评估。还评估了病例组和对照组中各检测方法之间的基因型一致性。Alinity m检测和cobas 6800检测的临床敏感性为96.0%，cobas 4800检测的临床敏感性为95.2%。观察到的Alinity m检测、cobas 6800检测和cobas 4800检测的临床特异性分别为67.6%、68.0%和68.4%。总体而言，这三种HPV检测方法表现出相似的临床性能。在≥CIN3组中，Alinity m检测和cobas 4800检测之间的基因型特异性阳性一致性≥98.4%，cobas 6800检测和cobas 4800检测之间的≥85.7%。在≤CIN1组中，三种检测方法之间的总体阳性一致性≥94.8%。本研究表明，Alinity m HR HPV检测、cobas 4800 HPV检测和cobas 6800 HPV检测具有相似的临床敏感性和特异性。Alinity m在检测HPV16和HPV18方面更具特异性，这可以减少不必要地立即将女性转诊至阴道镜检查。重要性本研究提供了证据，表明Alinity m HR人乳头瘤病毒（HPV）检测与两种广泛使用的检测方法cobas 4800 HPV检测和cobas 6800 HPV检测相比，具有相似的临床性能。在临床环境中对HPV检测进行验证至关重要，以确保它们在检测高级别宫颈上皮内瘤变时能够提供平衡的敏感性和特异性，通过实现适当的随访或治疗并避免不必要的程序，可能改善患者管理。
