TY - JOUR
T1 - Validation of a Human Papillomavirus (HPV) DNA cervical screening test that provides expanded HPV typing
AU - Demarco, Maria
AU - Carter-Pokras, Olivia
AU - Hyun, Noorie
AU - Castle, Philip E.
AU - He, Xin
AU - Dallal, Cher M.
AU - Chen, Jie
AU - Gage, Julia C.
AU - Befano, Brian
AU - Fetterman, Barbara
AU - Lorey, Thomas
AU - Poitras, Nancy
AU - Raine-Bennett, Tina R.
AU - Wentzensen, Nicolas
AU - Schiffman, Mark
N1 - Funding Information:
The field effort was a collaboration of the NCI and KPNC and was supported in part by the intramural program of the NCI. The NCI has received masked HPV and cytology test results at no cost from Roche Molecular Systems and BD Diagnostics for independent evaluations of these technologies. The statistical analysis was supported and led independently by the NCI. The manuscripts were composed and submitted without review by the diagnostics companies.
Funding Information:
The field effort was a collaboration of the NCI and KPNC and was supported in part by the intramural program of the NCI. The NCI has received masked HPV and cytology test results at no cost from Roche Molecular Systems and BD Diagnostics for independent evaluations of these technologies. The statistical analysis was supported and led independently by the NCI. The manuscripts were composed and submitted without review by the diagnostics companies. P.E.C. has received commercial HPV tests for research at reduced or no cost from Roche, Arbor Vita Corporation, and Cepheid.
PY - 2018/5
Y1 - 2018/5
N2 - 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 the FDA, by assessing (i) the association of Onclarity types/channels with precancer/cancer; (ii) HPV type/channel agreement between the results of Onclarity and cobas (Roche Molecular Systems, Pleasanton, CA), another FDA-approved test; and (iii) Onclarity typing for all types/channels compared to typing results from a research assay (linear array [LA]; Roche). 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. Hierarchical Onclarity channels showed a significant linear association with histological severity. Onclarity and cobas had excellent agreement on partial typing of HPV16, HPV18, and the other 12 types as a pool (sample-weighted kappa value of 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 groups of types identified by LA (kappa values from 0.80 for HPV39/68/35 to 0.97 for HPV16). Onclarity 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.
AB - 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 the FDA, by assessing (i) the association of Onclarity types/channels with precancer/cancer; (ii) HPV type/channel agreement between the results of Onclarity and cobas (Roche Molecular Systems, Pleasanton, CA), another FDA-approved test; and (iii) Onclarity typing for all types/channels compared to typing results from a research assay (linear array [LA]; Roche). 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. Hierarchical Onclarity channels showed a significant linear association with histological severity. Onclarity and cobas had excellent agreement on partial typing of HPV16, HPV18, and the other 12 types as a pool (sample-weighted kappa value of 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 groups of types identified by LA (kappa values from 0.80 for HPV39/68/35 to 0.97 for HPV16). Onclarity 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.
KW - Cervical screening
KW - Cobas
KW - Genotyping
KW - HPV DNA test
KW - Onclarity
KW - Typing
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U2 - 10.1128/JCM.01910-17
DO - 10.1128/JCM.01910-17
M3 - Article
C2 - 29491018
AN - SCOPUS:85046303465
SN - 0095-1137
VL - 56
JO - Journal of Clinical Microbiology
JF - Journal of Clinical Microbiology
IS - 5
M1 - e01910-17
ER -