Molecular HPV testing is routinely used for cervical disease management and HPV testing as a primary screen with reflex to cytology, HPV 16/18 genotyping or other triage method is becoming increasingly accepted as the optimal modality for cervical screening. There are a number of different molecular methods used to detect HPV and it is critical that any new HPV test undergoes robust technical evaluation and clinical validation before being used routinely for cervical disease management. With this in mind, an international panel of experts on cervical cancer screening proposed a standardized non-inferiority metric to adjudicate whether an HPV test conformed to acceptable standards of clinical performance.

Citation: Ejegod DM, Serrano I, Cuschieri KS, Nussbaumer WA, Vaughan LM, et al. (2013) Clinical Validation of the BD Onclarity™ HPV Assay Using a Non- Inferiority Test. J Med Microb Diagn S3:003.

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