The BD Onclarity HPV Assay on Samples Collected in SurePath Medium Meets the International Guidelines for Human Papillomavirus Test Requirements for Cervical Screening.
This study describes a validation of the BD Onclarity HPV (Onclarity) assay using the international guidelines for HPV test requirements for cervical cancer screening of women 30 years old and older using Danish SurePath screening samples. The clinical specificity (0.90, 95% confidence interval [CI] = 0.88 to 0.91) and sensitivity (0.97, 95% CI = 0.87 to 1.0) of the Onclarity assay were shown to be not inferior to the reference assay (specificity, 0.90 [95% CI = 0.88 to 0.92]; sensitivity, 0.98 [95% CI = 0.91 to 1.0]). The intralaboratory reproducibility of Onclarity was 97%, with a lower confidence bound of 96% (kappa value, 0.93). The interlaboratory agreement was 97%, with a lower confidence bound of 95% (kappa value, 0.92). The BD Onclarity HPV assay fulfills all the international guidelines for a new HPV test to be used in primarily screening. This is the first clinical validation of a new HPV assay using SurePath screening samples, and thus the Onclarity HPV assay is the first HPV assay to hold an international validation for both SurePath and ThinPrep.
Department of Pathology, Copenhagen University Hospital, Hvidovre, Denmark ditte.ejegod@regionh.dk.
Ditte
D
Ejegod
Division of Laboratory Medicine, European Institute of Oncology, Milan, Italy.
Fabio
F
Bottari
Department of Pathology, Copenhagen University Hospital, Hvidovre, Denmark.
Helle
H
Pedersen
Division of Laboratory Medicine, European Institute of Oncology, Milan, Italy.
Maria Teresa
MT
Sandri
Department of Pathology, Copenhagen University Hospital, Hvidovre, Denmark Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark.
Jesper
J
Bonde
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003718:Denmark; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D027383:Papillomaviridae / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000379:methods*