As cervical cancer screening shifts from cytology to human papillomavirus (HPV) testing, a major question is the clinical value of identifying individual HPV types. We aimed to validate Onclarity™ (Becton Dickinson Diagnostics, Sparks MD), a nine-channel HPV test recently approved by FDA, by assessing: 1) the association of Onclarity type/channels with precancer/cancer; 2) HPV type/channel agreement between Onclarity and cobas™ (Roche Molecular Systems, Pleasanton CA), another FDA-approved test; and 3) Onclarity typing for all types/channels compared to typing results from a research assay (Linear Array™, LA, Roche).Methods.We compared Onclarity to histopathology, cobas, and LA. We tested a stratified random sample (n=9,701) of discarded routine clinical specimens that had tested positive by Hybrid Capture 2 (HC2, Qiagen, Germantown MD). A subset had already been tested by cobas and LA (n=1,965). Cervical histopathology was ascertained from electronic health records.Results.Hierarchical Onclarity channels showed a significant linear association with histologic severity. Onclarity and cobas had excellent agreement on partial typing of HPV16, HPV18, and the other twelve types as a pool (sample-weighted kappa: 0.83); cobas was slightly more sensitive for HPV18 and slightly less sensitive for the pooled high-risk types. Typing by Onclarity showed excellent agreement with types and group of types identified by LA (kappas from 0.80 for HPV39/68/35 to 0.97 for HPV16).DiscussionOnclarity typing results corresponded well to histopathology and to an already-validated HPV DNA test, and could provide additional clinical typing if such discrimination is determined to be clinically desirable.
Validation of an HPV DNA cervical screening test that provides expanded HPV typing