Abstract
It is urgent to develop an accurate approach to improve the predictive performance of hrHPV-based screening. The aim is to evaluate the performance of p16/Ki-67 and p16/MCM2 staining to triage high-risk human papillomavirus- (hrHPV-) positive women. Cervical specimens were collected from eligible women and tested for hrHPV genotyping, cytology, p16/Ki-67, and p16/MCM2 staining at baseline. Women were invited to participate in follow-up screening by cytology and hrHPV testing at 24 months. Positive women received colposcopy and biopsies. Histopathological diagnoses were the gold standard. 485 women came back for the follow-up screening. The positive rate of p16/Ki-67 was 20.2% and of p16/MCM2 was 27.2%. The positive rates of p16/Ki-67 ( P < 0.001) and p16/MCM2 (P=0.021) were increased by the severity of histopathology findings. Among hrHPV-positive women, the sensitivity, specificity, PPV, and NPV for p16/Ki-67 were 90.9%, 67.0%, 16.5%, and 99.0%, and for p16/MCM2 were 81.8%, 43.1%, 9.4%, and 97.1%. The sensitivity of cytology for triaging hrHPV-positive women were lower than p16/Ki-67 (P=0.012) and p16/MCM2 (P=0.065). The cocktail staining did not add sensitivity to p16/Ki-67 or p16/MCM2 staining alone (P > 0.05), however, cutting down the specificity of p16/Ki-67 staining alone with statistical significance (67.0% vs. 40.2%, P < 0.001). The risk of CIN2+ within 24 months for hrHPV-positive but triaging negative women at baseline was 0.5 (0.1–2.7), 0.7 (0.1–4.1), and 2.4 (1.1–5.0) for p16/Ki-67, p16/MCM2, and cytology, respectively. As an objective and accurate immunocytochemical staining, the p16/Ki-67 and p16/MCM2 dual staining performed better than cytology to triage positive hrHPV. On condition that high-quality cytology is unavailable, immunocytochemical staining by p16/Ki-67 or p16/MCM2 is an option for triaging hrHPV-positive women. The combination of p16/Ki-67 and p16/MCM2 could not improve the accuracy in detecting CIN2+.
Highlights
Cervical cancer is one of the most common gynecological cancers worldwide
Prospective data are necessary to evaluate the protection among the Chinese population. is study was conducted to evaluate the performance of a cocktail immunocytochemical staining by p16/Ki-67 and/or p16/Minichromosomal maintenance protein 2 (MCM2) for detecting high-grade cervical intraepithelial neoplasia (CIN) among hrHPVpositive women
Since the unsatisfactory specificity for High-risk human papillomavirus (hrHPV) testing as primary screening and the difficulty to build a qualified cytology screening system, developing objective testing for triaging is required. e presented data imply that the p16/Ki-67 and p16/MCM2 staining are promising to triage high-risk human papillomavirus- (hrHPV-)positive women with high sensitivity and low risk for negative women [16]
Summary
The Performance of Immunocytochemistry Staining as Triaging Tests for High-Risk HPV-Positive Women: A 24-Month Prospective Study. Received 19 February 2020; Revised 27 April 2020; Accepted 12 May 2020; Published 26 May 2020
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