HPV-based cervical cancer screening requires triage markers to decide who should be referred to colposcopy. One candidate triage marker is detection of p16- or p16/Ki-67-stained cells (dual stain) in cytology. p16 and the dual stain have been evaluated for triage of ASC-US and LSIL cytology, for primary screening, and more recently for triage of HPV-positive and HPV-positive/cytology-negative women. A study at Kaiser Permanente Northern California (KPNC) showed that the dual stain assay can be implemented after limited training with high reproducibility. Furthermore, automated evaluation approaches are currently being developed. A prospective evaluation of p16 in an Italian cervical cancer screening trial showed that p16 is a viable option for triage of HPV-positive women, possibly allowing extending follow-up intervals of p16-negative women. Similarly, in an evaluation of the dual stain among women undergoing HPV-cytology co-testing at KPNC, dual stain-positive women had a risk of precancer higher than the colposcopy referral threshold while the risk among dual stain-negatives was below the threshold for a 1-year repeat test. Similar results were observed for HPV-positive/cytology-negative women in the same population. These findings suggest that the dual stain could be an effective triage strategy for HPV-positive and HPV-positive/cytology-negative women.
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