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

Background: Several options for the triage of high-risk HPV screen-positive (hrHPV(+)) women were assessed. Methods: 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. Results: 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 cytoimmunochemistry was significantly more sensitive than LBC although significantly less specific. Conclusions: 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. (C) 2017 AACR.