ArticleMicrobiology spectrum2025
Comparative clinical performance of Alinity m HR HPV, cobas 4800 HPV, and cobas 6800 HPV for cervical cancer screening.
Article in Microbiology spectrum, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
2 citing papers in PubMed.
- Clinical relevance of partial HPV genotyping in cervical cancer screening.Scientific reports · 2026Article
- Peripheral immune cell profiles and tumor marker expression in high-risk HPV-infected cervical lesions: a comparative study.Frontiers in oncology · 2026Article
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
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.
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