Abstract
Conclusions: Sensitivity for CIN3+ of p16/Ki-67 from SurePath medium in women with HPV positive LSIL is sufficient that immediate colposcopy is not required for women who are p16/Ki67 negative. Compared to current guidelines for LSIL cytology, p16/ Ki-67 triage could reduce immediate referral to colposcopy by 35%. Unlike p16 alone, which requires morphologic assessment of p16positive cells, p16/Ki-67 evaluation is based on staining alone and may be fully automated. Further studies are required to evaluate p16/Ki-67 for triage of HPV-positive women with NILM and ASC-US. If a negative predictive value of similar magnitude is observed for these women, a substantial and welcome decrement in the total number of colposcopies required will be possible without significant loss of sensitivity for the screening program.
Published Version
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