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 (avtor), Bertram, Alexander (avtor), Gröning, Arndt (avtor), Poljak, Mario (avtor)

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.

• Jezik: Angleški jezik
• Ključne besede: cervical cancer, human papillomavirus, screening, validation, alinity, cobas
• Vrsta gradiva: Članek v reviji
• Tipologija: 1.01 - Izvirni znanstveni članek
• Organizacija: MF - Medicinska fakulteta
• Status publikacije: Objavljeno
• Različica publikacije: Objavljena publikacija
• Leto izida: 2021
• Št. strani: 6 str.
• Številčenje: Vol. 140, art. 104851
• PID: 20.500.12556/RUL-138708
• UDK: 618.1
• ISSN pri članku: 1873-5967
• DOI: 10.1016/j.jcv.2021.104851
• COBISS.SI-ID: 95845379
• Datum objave v RUL: 10.08.2022

Gradivo je del revije

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

Licence

• Licenca: CC BY 4.0, Creative Commons Priznanje avtorstva 4.0 Mednarodna
• Povezava: http://creativecommons.org/licenses/by/4.0/deed.sl
• Opis: To je standardna licenca Creative Commons, ki daje uporabnikom največ možnosti za nadaljnjo uporabo dela, pri čemer morajo navesti avtorja.

Sekundarni jezik

• Jezik: Slovenski jezik
• Ključne besede: rak materničnega vratu, humani papiloma virus, presejanje