Evaluation of p16/Ki‐67 dual‐stain as triage test for high‐risk HPV‐positive women: A hospital‐based cross‐sectional study

Abstract

BACKGROUND: Most human papillomavirus (HPV)-positive women recover from infections and do not develop cervical intraepithelial neoplasia (CIN) and cervical cancer. Additional triage approaches are needed to reduce unnecessary colposcopy referrals. The aim of this study is to determine the high-risk HPV prevalence in a hospital-based population and to evaluate the performance of p16/Ki-67 dual-stain test for the triage of high-risk HPV-positive women to detect precursor lesions and cervical cancer compared with the ThinPrep cytologic test (TCT). METHODS: In a hospital-based population, 100,801 women were provided with a primary HPV DNA test and only women with high-risk HPV infections were triaged using TCT and p16/Ki-67 dual-stain test. CIN2 or worse (≥CIN2) or CIN3 or worse (≥CIN3) were defined as the clinical end points. RESULTS: The p16/ Ki-67 dual-stain indicated a statistically significant higher sensitivity (82.8% vs. 66.7%%), specificity (51.6% vs. 44.4%), positive predictive value (33.2% vs. 25.8%), negative predictive value (91.2% vs. 82.1%), and accuracy (58.6% vs. 49.4%) compared with TCT examination within ≥CIN2 cases. Similar patterns were observed for the ≥CIN3 end point. CONCLUSIONS: Our study demonstrated that p16/Ki-67 dual-stain test could achieve better performance compared with TCT examination for ≥CIN2 or ≥ CIN3 detection, representing a promising approach as a specific and efficient triage strategy for high-risk HPV-positive women.

Comprehensive evaluation of vaginal intraepithelial neoplasia development after hysterectomy: insights into diagnosis and treatment strategies

“…Previous studies have shown that p16/Ki-67 double staining has a sensitivity of 91.6% and specificity of 95.0% in detecting VAINII + [ 35 ]. Boonlikit et al found that compared to cytology screening, p16/Ki-67 double staining can be an effective triage strategy for HR-HPV-positive women [ 36 ].…”

Enhancing Cervical Cancer Screening: Review of p16/Ki-67 Dual Staining as a Promising Triage Strategy

“…Elevated Ki-67 levels in cervical cells suggest a higher rate of cell turnover, which is a characteristic of both dysplastic and neoplastic processes. Therefore, Ki-67 staining is often used in conjunction with other histopathological and cytological evaluations to assess the severity of cervical lesions [57,58]. In cervical cancer screening and management, Ki-67 can serve as an adjunct marker to improve the accuracy of cytological diagnosis.…”

“…Dual staining for p16 and Ki-67 is particularly useful in cervical cancer screening because these two proteins are mutually exclusive in normal cells [56,61,62]. Therefore, their co-expression serves as a specific marker for HPV-mediated oncogenic transformation and indicates a higher risk of cervical cancer [58,63]. This method helps differentiate between transient, harmless HPV infections and persistent infections with a higher potential to progress to high-grade pre-cancer or invasive carcinoma.…”