A positive HPV test with positive p16/Ki‐67 double staining in self‐sampled vaginal material is an accurate tool to detect women at risk for cervical cancer

Abstract

Background The development of efficient strategies for managing high‐risk human papillomavirus (HR‐HPV)–positive women is a major challenge when human papillomavirus–based primary screening is being performed. The objectives of this study were to evaluate the comparative effectiveness of HR‐HPV testing based on self‐collection (SC) and HR‐HPV testing based on collection by a health professional (HP) and to assess the potential usefulness of HR‐HPV testing combined with testing with the biomarkers p16/Ki‐67, α‐mannosidase, and superoxide dismutase 2 (SOD2). Methods This was a cross‐sectional study of 232 women admitted for colposcopy because of an abnormal Papanicolaou smear. The collected material underwent liquid‐based cytology, HR‐HPV detection, and immunocytochemical testing (p16/Ki‐67, α‐mannosidase, and SOD2). The gold standard was the histopathological result; the positive reference was CIN2+. Results The overall accuracy of HR‐HPV testing was 76.6%; the results for the SC group (78.1%) and the HP group (75.2%) were similar. The positive predictive values (HP, 76.5%; SC, 80.0%), the negative predictive values (HP, 66.7%; SC, 64.3%), the positive likelihood values (HP, 1.35; SC, 1.36), and the negative likelihood values (HP, 0.21; SC, 0.19) were also similar. p16/Ki‐67 showed higher sensitivity than the other 2 biomarkers: 78.1% versus 45.8% for α‐mannosidase and 44.5% for SOD2. The specificities of the biomarkers were equivalent: 71.4% for p16/Ki‐67, 77.8% for α‐mannosidase, and 71.2% for SOD2. In the HP group, accuracy also leaned more heavily toward the final score (using α‐mannosidase and SOD2) without statistical significance (80.8% vs 77.9%). The contrast with the SC group yielded the same level of accuracy. Conclusions SC, when associated with testing with biomarkers, is as accurate as collection by HPs in the detection of women at risk for cervical cancer.

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

“…Recent advancements in cervical cancer screening have increased the efficacy of the p16/Ki-67 dual-staining technique, particularly for triaging human papillomavirus (HPV)positive women [64,65]. A growing body of research indicates that this dual-staining method outperforms traditional cytology in several key aspects, notably sensitivity and negative predictive value (NPV), albeit with a trade-off in specificity [14,56].…”

p16/Ki67 dual stain triage versus cytology in primary human papillomavirus‐based cervical cancer screening with limited genotyping

“…The Polish Interim cervical cancer screening guidelines have recommended a wider p16/Ki67 usage during the SARS‐CoV‐2 pandemic 4 . Recently, it has also been studied for use in self‐sampling, 23 which may open up new possibilities in the management of abnormal screening test results in non‐responders in cervical cancer systems of prevention.…”