Defining Optimal Triage Strategies for hrHPV Screen-Positive Women-An Evaluation of HPV 16/18 Genotyping, Cytology, and p16/Ki-67 Cytoimmunochemistry.

Several options for the triage of high-risk HPV screen-positive (hrHPV) women were assessed. This study incorporated CIN2 cases and controls, all of whom tested hrHPV and whose results of liquid-based cytology (LBC), HPV16/18 genotyping, and p16/Ki67 cytoimmunochemistry were available. Sensitivity and specificity for the CIN2 of these triage tests were evaluated. Absolute sensitivities of HPV 16/18 typing, LBC, and p16/Ki-67 cytoimmunochemistry for CIN2 detection were 61.7%, 68.3%, and 85.0% for women with hrHPV clinician-taken samples. Respective specificities were 70.5%, 89.1%, and 76.7%. The absolute accuracy of the triage tests was similar for women with a hrHPV self-sample. P16/Ki-67 cyto-immunochemistry was significantly more sensitive than LBC although significantly less specific. All three single-test triage options, if positive, exceed the threshold of 20% risk at which colposcopy would be indicated. However, none of them conferred a post-test probability of CIN2 <2%; which would permit routine recall. P16/Ki-67 cytoimmunochemistry on HPV16/18 negative women had a post-test probability of CIN2 of 1.7% and 0.6% if also LBC negative. This is one of the few studies to directly compare the performance of triage strategies of hrHPV women, in isolation and combinations. It is the only study assessing triage strategies in women who test hrHPV in self-taken vaginal samples. A combined triage option that incorporated HPV 16/18 typing prior to p16/ki-67 cytoimmunochemistry in HPV 16/18-negative women yielded a post-test probability of CIN2 of >20%, whereas women who tested negative had a probability of CIN2 of <2%. .