Abstract: OBJECTIVE: To investigate the value of P16/Ki-67 double staining combined with DNA ploidy analysis in the atypical squamous cells of undetermined significance (ASCUS) shunt. METHODS: The valid cytological samples from 115 patients diagnosed as ASCUS in Changning Maternity and Child Healthcare Hospital of Shanghai,from December 2016 to August 2018,were collected from LCT test. P16/Ki-67 double staining and DNA ploidy analysis were tested at the same time. The gold standard was the pathological biopsy results of colposcopy. RESULTS: Pathological examination showed that there were 45 cases of cervical intraepithelial neoplasia 2 or above (CIN2+),including 20 cases of CIN2,23 cases of CIN3 and 2 cases of squamous cell carcinoma. Among the 115 patients,the sensitivity,specificity and diagnostic coincidence rate of CIN2+ by P16/Ki-67 double staining were 77.8%,77.1% and 77.4%,respectively;the sensitivity,specificity and diagnostic coincidence rate of CIN2+ by DNA ploidy analysis were 71.1%,34.3%,48.7%,respectively,and the P16/Ki-67 double staining test results were negative in the DNA ploidy negative cell samples. DNA ploidy analysis combined with P16/Ki-67 double staining detection found that the sensitivity, specificity, and diagnostic coincidence rate of CIN2+ were 92.9%,71.4%,86.3%,respectively,of which the diagnostic coincidence rate was significantly higher than that of DNA ploidy analysis alone (P < 0.05). CONCLUSION: P16/Ki-67 double staining has higher sensitivity and specificity than DNA ploidy analysis for CIN2+. In addition,combination of the two methods effectively improved the accuracy for the shunt diagnosis of ASCUS.

Key words: P16/Ki-67 double staining, DNA ploidy analysis, atypical squamous cells of undetermined significance, diagnostic value