Papilloplex HR-HPV test has non-inferior clinical performance for detection of human papillomavirus infection: assessment using the VALGENT framework. Issue 3 (15th November 2021)

• Record Type: Journal Article
• Authors: Bhatia, Ramya; Alcaniz Boada, Elia; Bonde, Jesper Hansen; Quint, Wim G V; Xu, Lan; Ejegod, Ditte Moller; Cuschieri, Kate; Arbyn, Marc
• Is Part Of: Journal of clinical pathology. Volume 76:Issue 3(2023)
• Page Start: 172
• Page End: 176
• Publication Date: 2021-11-15
• Subjects: HPV -- papillomavirus Infections -- polymerase chain reaction -- diagnostic screening programs; Pathology -- Periodicals; Pathology, Molecular -- Periodicals; 616.0705
• DOI: 10.1136/jclinpath-2021-207864
• Languages: English
• ISSNs: 0021-9746

Abstract

Abstract : Aim: The Papilloplex high-risk human papillomavirus (hrHPV) test (Genefirst, Oxford, UK) is a single tube real-time HPV test which provides multiplex detection and separate identification of 14 hrHPV types. Here, we present the clinical validation of the test in SurePath samples in comparison to a clinically validated reference test, the GP5+/6+Enzyme ImmunoAssay (GP5+/6+EIA) using the VALGENT (VALidation of HPV GENotyping Tests) framework. Methods: Clinical performance was assessed using 998 unselected, cervical screening samples enriched with 297 cytologically abnormal specimens (100 atypical squamous cells of unspecified significance, 100 low-grade squamous intraepithelial lesions, 97 high-grade squamous intraepithelial lesions). Cases were defined as women diagnosed with histologically confirmed cervical intraepithelial neoplasia two or more (≥CIN2, N=119) and controls defined as women with two subsequent negative cytology results (N=834). Results: The Papilloplex HR-HPV test has non-inferior sensitivity for detection of cervical precancer (p=0.0001 for ≥CIN2 and p=0.0005 for ≥CIN3) and non-inferior specificity, compared with GP5+/6+EIA (pni=0.0167)). The assay also showed excellent or good agreement for overall hrHPV and nearly all individual HPV types as compared with GP5+/6+EIA/Luminex. Conclusion: The Papilloplex HR-HPV applied on cervical specimens stored in SurePath medium fulfils the international clinical accuracy criteria for use in cervical cancer screening.