Comparison of the clinical and analytical performance of Alinity m HR HPV and cobas 4800 HPV assays in a population-based screening setting

Oštrbenk Valenčak, Anja (author), Bertram, Alexander (author), Gröning, Arndt (author), Poljak, Mario (author)

Background: The recently launched Abbott Alinity m HR HPV (Alinity) assay separately identifies high-risk human papillomavirus (hrHPV) genotypes HPV16, HPV18, and HPV45, and reports 11 other genotypes as two aggregates. Methods: Clinical and analytical performance of Alinity was compared with the cobas 4800 HPV assay on 4,334 women aged 20–64 years attending routine, population-based organized cervical cancer screening during 2009/ 2010. After 36 months, they were invited to participate in the second screening round (2012–2014) and later followed-up through centralized national cervical cancer screening registry. Results: In women 30 and older, the clinical sensitivity for cervical intraepithelial neoplasia grade 2+ (CIN2+) was 100.0% (95% CI, 88.2–100.0%) for Alinity and 100.0% (95% CI, 88.2–100.0%) for cobas, and for CIN3+ 100.0% (95% CI, 78.9–100.0%) for both assays. The clinical specificity for ≤ CIN1 in women 30 and older was 92.4% (95% CI, 91.4–93.3%) and 92.9% (95% CI, 91.9–93.7%), respectively. The assays demonstrated excellent overall agreement for hrHPV detection (97.9%) and genotype-specific agreement for HPV16 (99.6%), HPV18 (99.8%), and other hrHPV (98.1%). Overall positive agreement and positive agreements for HPV16, HPV18, and other hrHPV genotypes were 84.3%, 89.1%, 73.2%, and 82.3%. Based on a 5-year CIN3+ risk, slightly more HPV-positive women would require referral to immediate colposcopy after testing with Alinity vs. cobas (4.1% vs. 3.8%; p = 0.470), but significantly fewer Alinity-tested women would need a 6- to 12-month follow-up visit compared with those tested with cobas (5.0% vs. 8.6%; p < 0.0001). Conclusions: Alinity and cobas have comparable clinical performance and showed excellent overall and genotypespecific agreement. The Alinity’s extended genotyping ability could help predict the 5-year CIN3+ risk and costsaving management of HPV-screen-positive women.

• Language: English
• Keywords: cervical cancer, human papillomavirus, screening, validation, alinity, cobas
• Work type: Article
• Typology: 1.01 - Original Scientific Article
• Organization: MF - Faculty of Medicine
• Publication status: Published
• Publication version: Version of Record
• Year: 2021
• Number of pages: 6 str.
• Numbering: Vol. 140, art. 104851
• PID: 20.500.12556/RUL-138708
• UDC: 618.1
• ISSN on article: 1873-5967
• DOI: 10.1016/j.jcv.2021.104851
• COBISS.SI-ID: 95845379
• Publication date in RUL: 10.08.2022

Record is a part of a journal

• Title: Journal of clinical virology
• Publisher: Elsevier
• ISSN: 1873-5967
• COBISS.SI-ID: 23214341

Licences

• License: CC BY 4.0, Creative Commons Attribution 4.0 International
• Link: http://creativecommons.org/licenses/by/4.0/
• Description: This is the standard Creative Commons license that gives others maximum freedom to do what they want with the work as long as they credit the author.

Secondary language

• Language: Slovenian
• Keywords: rak materničnega vratu, humani papiloma virus, presejanje