Comparative clinical performance of Alinity m HR HPV, cobas 4800 HPV, and cobas 6800 HPV for cervical cancer screening

• Published in: Microbiology Spectrum
• Main Authors: Shihai Huang, Luciana Girotto Gentil, Colleen Schmidt, Richard Cullum, Yan Zhang, Kevin Nelson, Danijela Lucic, Klara Abravaya
• Format: Article
• Language: English
• Published: American Society for Microbiology 2025-09-01
• Subjects: cervical cancer; HPV test; primary screening; HPV genotyping
• Online Access: https://journals.asm.org/doi/10.1128/spectrum.00589-25

ABSTRACT 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.