The Allplex HPV HR Detection assay fulfils international guideline requirements for primary cervical screening on SurePath samples and qualifies as a second-generation HPV comparator test

Oštrbenk Valenčak, Anja (author), Pedersen, Helle (author), Poljak, Mario (author), Bonde, Jesper (author)

A key parameter for the continued success of cervical cancer screening is quality-controlled use of human papillomavirus (HPV) tests that are clinically validated according to international guidelines. The clinical accuracy for cervical screening of the Allplex HPV HR Detection (Allplex), which concurrently detects and distinguishes 12 high-risk HPV types (16,18,31,33,35,39,45,51,52,56,58,59) and HPV66 and HPV68 was assessed on SurePath samples by comparing its performance to the second-generation comparator BD Onclarity HPV assay (Onclarity). The absolute clinical sensitivity, assessed on 76 samples derived from a screening population with underlying CIN2+, of Allplex and Onclarity was 98.7 % (95 % CI, 92.9–100.0 %) and 100.0 % (95 % CI, 95.2–100.0 %), respectively, with relative sensitivity of Allplex of 0.99 (95 % CI; 0.96–1.01). The absolute clinical specificity, assessed on 801 consecutive clinician-collected cervical samples obtained from women 30 to 59 years old attending the routine Danish cervical screening program, for Allplex and Onclarity was 92.5 % (95 % CI, 90.4–94.2 %) and 92.5 % (95 % CI, 90.4–94.2 %), respectively, with relative specificity of Allplex of 1.00 (95 % CI; 0.99–1.01). With thresholds mandated by international guidelines of ≥90 % for relative clinical sensitivity (p = 0.001) and ≥98 % for relative clinical specificity (p = 0.0018), Allplex was non-inferior to Onclarity. Excellent intra- and inter-laboratory agreement of Allplex was observed, both overall (99.2 % and 99.6 %) and at the genotype level (range: 99.6–100.0 %). By fulfilling all guideline requirements for clinical sensitivity, specificity, and reproducibility, Allplex can be considered clinically validated for primary cervical screening using clinician-collected SurePath samples. With this study, Allplex also meets the criteria for a secondgeneration HPV comparator test.

• Language: English
• Keywords: Allplex HPV HR, cervical cancer, clinical validation, HPV-based primary cervical screening, human papillomaviruses, SurePath
• Work type: Article
• Typology: 1.01 - Original Scientific Article
• Organization: MF - Faculty of Medicine
• Publication status: Published
• Publication version: Version of Record
• Year: 2025
• Number of pages: 6 str.
• Numbering: Vol. 180, art. 105853
• PID: 20.500.12556/RUL-182616
• UDC: 618.1
• ISSN on article: 1873-5967
• DOI: 10.1016/j.jcv.2025.105853
• COBISS.SI-ID: 250554371
• Publication date in RUL: 19.05.2026

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, klinična validacija, primarni presejalni testi za maternični vrat na podlagi HPV, humani papiloma virusi