Allplex HPV HR Detection assay fulfils all clinical performance and reproducibility validation requirements for primary cervical cancer screening
Open accessAbstract
Human papillomavirus (HPV)-based screening offers better protection against cervical cancer compared to cytology, but HPV screening assays must adhere to validation requirements of the international guidelines to ensure optimal performance. Allplex HPV HR Detection (Allplex) assay, launched in the late 2022, is a fully automated real-time PCR-based assay utilizing innovative technology that enables quantification and concurrent distinction of 14 high-risk HPV genotypes (HPV16,18,31,33,35,39,45,51,52,56,58,59,66 and 68). We assessed the validity of the Allplex for cervical cancer screening purposes, via comparison to a clinically validated comparator assay (Hybrid Capture 2; HC2), and through assessment of intra-laboratory reproducibility and inter-laboratory agreement. A clinical validation panel comprised of 973 residual ThinPrep samples was obtained from women aged 30-64 years participating in the organized Slovenian screening program, of these 863 were from women undergoing their regular screening visit after a previous negative screen test while 110 were from women with underlying cervical intraepithelial neoplasia grade 2 or worse (CIN2+) lesions. The Allplex's relative clinical sensitivity for detection of CIN2+ and CIN3+ were 1.01 (95%CI;0.98-1.04) and 0.98 (95%CI;0.95-1.02), compared to that of HC2. At recommended thresholds of ≥98% and ≥90%, the Allplex's clinical sensitivity and specificity (p=0.0004 and p=0.02, respectively) were non-inferior to HC2. High intra-laboratory reproducibility and inter-laboratory agreement, both overall (98.1% and 97.9%, respectively) and at genotype level (>98.7%) was observed. In addition, analytical genotype-specific performance of Allplex was compared to that of its predecessor Anyplex HPV HR; high overall agreement was observed (96.3%; kappa value 0.88), with some variations in performance. In conclusion, Allplex met all validation criteria described in the international guidelines on sensitivity, specificity and laboratory reproducibility and can be considered clinically validated for primary cervical cancer screening.
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Oštrbenk Valenčak A. et al. reported a statistically significant difference in overall genotype detection (p < 0.0001) and for three specific genotypes: HPV31, HPV51, and HPV68 - in favor of the Anyplex II HPV HR assay, with p-values of 0.002, 0.02, and 0.008, respectively (using the clinically validated Ct cut-offs).
“In contrast, Oštrbenk Valenčak A. et al. reported a statistically significant difference in overall genotype detection (p < 0.0001) and for three specific genotypes: HPV31, HPV51, and HPV68 - in favor of the Anyplex™ II HPV HR assay, with p-values of 0.002, 0.02, and 0.008, respectively (using the clinically validated Ct cut-offs) [20].”
From Comparative evaluation of Allplex HPV28 and Anyplex II HPV28 assays for high-risk HPV genotyping in cervical samples (2025) · cites this paper as [20]
A study by Oštrbenk Valenčak A. et al. reported a high overall agreement between the Allplex HPV HR and Anyplex II HPV HR assays (96.3% concordance, K = 0.88).
“In another study conducted by Oštrbenk Valenčak A. et al., a high overall agreement was reported between the Allplex™ HPV HR and the Anyplex™ II HPV HR assays (96.3% concordance, K = 0.88).”
From Comparative evaluation of Allplex HPV28 and Anyplex II HPV28 assays for high-risk HPV genotyping in cervical samples (2025) · cites this paper as [20]
The study by Oštrbenk Valenčak A. et al. concluded that the Allplex HPV HR assay meets all validation criteria outlined in the international guidelines for HPV testing in primary cervical cancer screening for women aged 30 years and older.
“This finding aligns with the study performed by Oštrbenk Valenčak A. et al., which concluded that the Allplex™ HPV HR assay meets all validation criteria outlined in the international guidelines for HPV testing in primary cervical cancer screening for women aged 30 years and older [20].”
From Comparative evaluation of Allplex HPV28 and Anyplex II HPV28 assays for high-risk HPV genotyping in cervical samples (2025) · cites this paper as [20]
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- Authors
- Oštrbenk Valenčak, A., Cuschieri, K., Connor, L., Zore, A., Smrkolj, Š., & Poljak, M.
- Affiliations
- Edinburgh Royal Infirmary (GB)
- University of Ljubljana (SI)
- Corresponding author
- Poljak, Mario
- Venue
- Journal of Clinical Virology
- Publisher
- Elsevier BV
- Published
- 2024-02
- Volume
- 170
- Pages
- 105638
- ISSN
- 1386-6532 (ISSN-L)
- OpenAlex
- W4390483142
- Cited by
- 20
- References
- 23
- Citations by year
- 2026: 7 · 2025: 9 · 2024: 4
- FWCI
- 6.15
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Journal of Clinical Virology (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- DiRROS repository (University of Maribor) (submittedVersion, cc-by-nc)
- dCOBISS.SI Digital Repository (submittedVersion, cc-by-nc-nd)
- Funders
- European Commission (847845)
- Javna Agencija za Raziskovalno Dejavnost RS (P3‐00083, 847845)
- Topics
- Health Sciences › Medicine › Epidemiology › Cervical Cancer and HPV Research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Women's cancer prevention and management
- Life Sciences › Immunology and Microbiology › Microbiology › Reproductive tract infections research
- Keywords
- HPV-based cervical cancer screening, high-risk HPV genotypes, Hybrid Capture 2, clinical validation, sensitivity and specificity, interlaboratory agreement, cervical intraepithelial neoplasia, real-time PCR
- MeSH terms
- Uterine Cervical Dysplasia, Uterine Cervical Neoplasms, Female, Genotype, Humans, Sensitivity and Specificity, Reproducibility of Results, Papillomaviridae, Papillomavirus Infections, Early Detection of Cancer
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