摘要
Background The management of atypical squamous cells of undetermined significance/low-grade squamous intraepithelial lesions （ASCUS/LSIL） is still controversial and it is advisable to make a triage for these two cytological abnormalities. P16INK4 （P16） has been shown to be a potential biomarker for predicting high-grade cervical intraepithelial neoplasia （CIN） and cervical cancer. The aim of the study was to determine the value of P16 expression by immunostaining method compared with high-risk human papillomavirus （HR-HPV） DNA test in the triage of ASCUS/LSIL women. Methods Totally 86 eligible residual liquid-based cytological specimens with ASCUS and 45 with LSIL were obtained. All specimens were submitted to HR-HPV DNA test （HC2） and P16 immunocytochemical staining simultaneously. And all women underwent colposcopy and biopsy after cytology. Results The positive rate of P16 staining was 32.6% in ASCUS and 42.2% in LSIL, which was significantly lower than that of HR-HPV test in both ASCUS （P〈0.05） and LSIL （P〈0.05）. Moreover, the positive rate of P16 staining was 12.7% in normal histology, 61.5% in CIN 1,87.0% in CIN 2-3, and 100.0% in cancer, in which P16 positive rate was significantly lower than HR-HPV positive rate in normal group. The sensitivity, specificity, positive predictive value （PPV）, negative predictive value （NPV） and accuracy of P16 staining for predicting CIN 2 or more were 87.5%, 68.6%, 38.9%, 96.0%, and 72.1%, respectively in the ASCUS; while 90.0%, 71.4%, 47.4%, 96.2% and 54.7%, respectively in the LSIL, in which the specificity and accuracy of P16 staining were significantly higher than those of HR-HPV test in both ASCUS and LSIL （P 〈0.05）. Conclusion P16 immunostaining had significantly higher specificity and accuracy than HR-HPV DNA test for predicting for high-grade CIN and cervical cancer in ASCUS and LSIL and can be used for the triage of women with ASCUS/LSIL cytological abnormality.
Background The management of atypical squamous cells of undetermined significance/low-grade squamous intraepithelial lesions （ASCUS/LSIL） is still controversial and it is advisable to make a triage for these two cytological abnormalities. P16INK4 （P16） has been shown to be a potential biomarker for predicting high-grade cervical intraepithelial neoplasia （CIN） and cervical cancer. The aim of the study was to determine the value of P16 expression by immunostaining method compared with high-risk human papillomavirus （HR-HPV） DNA test in the triage of ASCUS/LSIL women. Methods Totally 86 eligible residual liquid-based cytological specimens with ASCUS and 45 with LSIL were obtained. All specimens were submitted to HR-HPV DNA test （HC2） and P16 immunocytochemical staining simultaneously. And all women underwent colposcopy and biopsy after cytology. Results The positive rate of P16 staining was 32.6% in ASCUS and 42.2% in LSIL, which was significantly lower than that of HR-HPV test in both ASCUS （P〈0.05） and LSIL （P〈0.05）. Moreover, the positive rate of P16 staining was 12.7% in normal histology, 61.5% in CIN 1,87.0% in CIN 2-3, and 100.0% in cancer, in which P16 positive rate was significantly lower than HR-HPV positive rate in normal group. The sensitivity, specificity, positive predictive value （PPV）, negative predictive value （NPV） and accuracy of P16 staining for predicting CIN 2 or more were 87.5%, 68.6%, 38.9%, 96.0%, and 72.1%, respectively in the ASCUS; while 90.0%, 71.4%, 47.4%, 96.2% and 54.7%, respectively in the LSIL, in which the specificity and accuracy of P16 staining were significantly higher than those of HR-HPV test in both ASCUS and LSIL （P 〈0.05）. Conclusion P16 immunostaining had significantly higher specificity and accuracy than HR-HPV DNA test for predicting for high-grade CIN and cervical cancer in ASCUS and LSIL and can be used for the triage of women with ASCUS/LSIL cytological abnormality.
