ABSTRACT
Objective:To investigate the screening values of immunocytochemical P16/Ki-67 double staining, P16 INK4α single staining and high-risk human papillomavirus (HR-HPV) testing for high-grade cervical lesions. Methods:The clinical data of 622 patients who underwent cervical thin-layer liquid-based cytology (TCT) and HR-HPV testing in General Hospital of Taiyuan Iron and Steel (Group) Co., Ltd. from March 2019 to July 2021 were retrospectively analyzed. The remaining cytological specimens were detected by P16/Ki-67 double staining and P16 INK4α single staining. Among them, 334 patients with TCT results suggesting atypical squamous cell of undetermined significance (ASCUS) and above and HPV-positive underwent colposcopy pathological biopsy. Using pathological results as reference, the positive predictive value, sensitivity, specificity and accuracy of P16/Ki-67 double staining, P16 INK4α single staining and HR-HPV testing for screening of high-grade squamous intraepithelial neoplasia (HSIL) and cervical cancer were compared. Results:Taking the results of histopathology as references, combined with the results of TCT, 31 of 622 patients were HSIL, of which 22 (71.0%) were positive for P16/Ki-67 double staining, 23 (74.2%) were positive for P16 INK4α single staining, and 25 (80.6%) were positive for HR-HPV testing; 4 cases were cervical cancer, and the positive rates of the three detection methods were all 100.0% (4/4). Among 622 patients, the positive rates of P16/Ki-67 double staining, P16 INK4α single staining and HR-HPV testing for screening of HSIL and cervical cancer were 13.99% (87/622), 25.40% (158/622) and 21.38% (133/622); the positive predictive values were 29.89%, 17.09% and 21.08%; the accuracies were 91.19%, 78.94% and 83.28%; the specificities were 89.77%, 77.98% and 82.46%; the sensitivities were 74.29%, 77.14% and 82.86%. The positive rate, positive predictive value, specificity and accuracy of P16/Ki-67 double staining were higher than those of P16 INK4α single staining and HR-HPV testing, and the differences were statistically significant ( z values were -5.062 and -3.418, 2.328 and 2.450, 5.436 and 3.570, 6.043 and 4.161, all P < 0.05); the sensitivity of HR-HPV testing was higher than that of P16/Ki-67 double staining and P16 INK4α single staining, but the differences were not statistically significant ( z values were -0.890 and 1.017, both P > 0.05). Conclusions:HR-HPV testing is more suitable for primary cervical lesion screening; P16/Ki-67 double staining can be used as a potential combined cell screening tool or an effective triage tool; P16 INK4α single staining has certain limitations.
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Objective:To explore the detection capability of p16/Ki-67 double staining technique in women with various abnormal thinprep cytologic test (TCT) results and its diagnostic value for cervical intraepithelial neoplasia Ⅱ+ grade (CIN2+).Methods:A total of 225 women with abnormal TCT results, i.e. the atypical squamous cells of undetermined significance(ASC-US), in the Tianjin Central Hospital of Gynecology Obstetrics, Nankai University Affiliated Maternity Hospital from December 2018 to December 2019 were enrolled. p16/Ki-67 double staining were detected and compared with the high risk human papillomavirus (HR-HPV) and pathological results.Results:The positive rates of p16/Ki-67 double staining increased with cytologic and pathologic categories. For diagnosis of CIN2+, p16/Ki-67double staining (90.1%) was less sensitive than HR-HPV testing (98.2%)( P<0.05), but the specificity of p16/Ki-67 double staining (58.8%) was significantly higher than HR-HPV(21.6%) ( P<0.001). Conclusions:Compared with HR-HPV, p16/Ki-67 double staining has better effect on diagnosing CIN2+. p16/Ki-67 double staining can be considered as triaging method for management of ASC-US and LSIL patients, significantly reduce the colposcopy referral rate (nearly 50%), which has high clinical application value.
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Objective To investigate the diagnostic value of DNA ploidy analysis combined with immunocytochemistry p16/ki-67 double staining in cervical high grade squamous intraepithelial neoplasia(HSIL) and cervical squamous cell carcinoma(SCC).Methods A total of 73 cases of cytological tests were randomly collected.Among them,53 cases were small DNA ploidy abnormal cells and 20 cases were DNA ploidy negative.The p16/Ki-67 results were detected by immunocytochemistry double staining.With the pathological results as the golden standard,the diagnostic values of DNA ploidy analysis and DNA ploidy analysis combined with p16/Ki-67 double staining in HSIL + was contrastively analyzed by pathologic results.Results Among 20 samples of DNA ploidy negative,the p16/Ki-67 double staining results all were negative.The positive predictive value of DNA ploidy analysis for HSIL + was 34.62％.The sensitivity of DNA ploidy analysis combined with p16/Ki-67 double staining for HSIL + was 84.62％,and its specificity was 92.31％,the positive predictive value was 78.57％ and the negative predictive value was 94.74％,which were significantly higher than those of DNA ploidy analysis(P＜0.05).Conclusion p16/Ki-67 double staining can significantly im prove the prediction value of HSIL.The DNA ploidy analysis combined with p16/Ki-67 double staining is an effective method for predicting HSIL +,which is suitable for the implementation in the areas with lack of medical resources.