Evaluation the triage performance of p16/Ki-67 dual staining for HR-HPV positive women / 中华预防医学杂志

Objective@#This study aimed to evaluate the clinical performance of p16/Ki-67 dual staining for triage high risk HPV (HR-HPV) infected women.@*Method@#Target objects were women who infected HR-HPV and received colposcopy examination between April and December of 2016 at the Second Affiliated Hospital of Zhengzhou University. Gynecologists collected the cervical exfoliated cells from eligible women for p16/Ki-67 dual staining, LBC testing and HPV DNA testing. Histology diagnosis were used as gold standard. Sensitivities, specificities, positive predictive values (PPVs), negative predictive values (NPVs) of p16/Ki-67 dual staining, LBC testing and HPV16/18 testing for triage of HR-HPV positive population were calculated and compared.@*Results@#A total of 295 HR-HPV infected women were selected, and the mean age was (44.29±11.48) years old. Positive rates of p16/Ki-67 dual staining, HPV16/18 testing and LBC testing were 70.17% (207), 56.95% (168) and 85.76% (253), respectively. When CIN2+as the endpoint, among the three triage methods, sensitivity of p16/Ki-67 dual staining was 90.00% (95%CI: 85.06%-93.43%), higher than the value of HPV 16/18 testing, but lower than the value of LBC testing. Specificity, PPV and NPV of p16/Ki-67 dual staining were the highest [71.58% (95%CI: 61.81%-79.67%), 86.96% (95%CI:81.69%-90.88%) and 77.27% (95%CI: 67.49%-84.78%)]. When detection for CIN3+, sensitivity of p16/Ki-67 dual staining was 92.90% (95%CI: 87.74%-95.99%), lower than the value of LBC testing, but higher than the value of HPV16/18 testing. Specificity of p16/Ki-67 dual staining was 55.00% (95%CI: 46.74%-63.00%), lower than the value of HPV16/18 testing, but higher than the value of LBC testing. PPV of p16/Ki-67 dual staining was 69.57% (95%CI: 62.99%-75.43%), lower than the value of HPV 16/18 testing, but higher than the value of LBC testing. NPV of p16/Ki-67 dual staining was 87.50% (95%CI: 78.99%-92.87%), higher than value of HPV 16/18 testing, but lower than the value of LBC testing.@*Conclusion@#p16/Ki-67 dual staining has better clinical effects than HPV 16/18 testing and LBC testing for triage women with HR-HPV infection.

Evaluation the triage performance of p16/Ki-67 dual staining for HR-HPV positive women / 中华预防医学杂志

This study aimed to evaluate the clinical performance of p16/Ki-67 dual staining for triage high risk HPV (HR-HPV) infected women. Target objects were women who infected HR-HPV and received colposcopy examination between April and December of 2016 at the Second Affiliated Hospital of Zhengzhou University. Gynecologists collected the cervical exfoliated cells from eligible women for p16/Ki-67 dual staining, LBC testing and HPV DNA testing. Histology diagnosis were used as gold standard. Sensitivities, specificities, positive predictive values (PPVs), negative predictive values (NPVs) of p16/Ki-67 dual staining, LBC testing and HPV16/18 testing for triage of HR-HPV positive population were calculated and compared. A total of 295 HR-HPV infected women were selected, and the mean age was (44.29±11.48) years old. Positive rates of p16/Ki-67 dual staining, HPV16/18 testing and LBC testing were 70.17% (207), 56.95% (168) and 85.76% (253), respectively. When CIN2+as the endpoint, among the three triage methods, sensitivity of p16/Ki-67 dual staining was 90.00% (95: 85.06%-93.43%), higher than the value of HPV 16/18 testing, but lower than the value of LBC testing. Specificity, PPV and NPV of p16/Ki-67 dual staining were the highest [71.58% (95: 61.81%-79.67%), 86.96% (95:81.69%-90.88%) and 77.27% (95: 67.49%-84.78%)]. When detection for CIN3+, sensitivity of p16/Ki-67 dual staining was 92.90% (95: 87.74%-95.99%), lower than the value of LBC testing, but higher than the value of HPV16/18 testing. Specificity of p16/Ki-67 dual staining was 55.00% (95: 46.74%-63.00%), lower than the value of HPV16/18 testing, but higher than the value of LBC testing. PPV of p16/Ki-67 dual staining was 69.57% (95: 62.99%-75.43%), lower than the value of HPV 16/18 testing, but higher than the value of LBC testing. NPV of p16/Ki-67 dual staining was 87.50% (95: 78.99%-92.87%), higher than value of HPV 16/18 testing, but lower than the value of LBC testing. p16/Ki-67 dual staining has better clinical effects than HPV 16/18 testing and LBC testing for triage women with HR-HPV infection.

Study of predictive value for detection of high-grade cervical intraepithelial neoplasia by p16/Ki-67 dual-stained liquid-based cytology / 临床与实验病理学杂志

Purpose To study of predictive value for detection of high-grade cervical intraepithelial neoplasia (CIN2 +) by p16/Ki-67 dual-stained liquid-based cytology.Methods Random collection of 123 women including 103 samples of atypical squamous cell of undetermined significance (ASC-US) and above with results of high-risk human papillomavirus (HR-HPV)testing and cervical biopsy,20 samples of negative for intraepithelial lesion or malignancy (NILM) by using immunocytochemical p16/Ki-67 dual-stained and the morphology assessment.Results In normal control group,the expression of p16/Ki-67 dual-stained in squamous epithelial cells were negative.Sensitivity of p16/Ki-67 dual-staind cytology for biopsy-confirmed CIN2 + was 66.67％ (ASC-US),91.67％ (LSIL) and 92.86％ (HSIL),specificity rates were 95.92％ (ASC-US),95.00％ (LSIL) and 0 (HSIL),positive predictive value were 50.00％ (ASC-US),91.67％ (LSIL) and 92.86％ (HSIL),negative predictive value were 97.92％ (ASC-US),95.00％(LSIL) and 0 (HSIL),respectively.Condusion p16/Ki-67 dual-stained cytology are improved obviously the predictive value for detection of CIN2 +,p16/Ki-67 dual-stained cytology may efficiently complement HPV-based screening programs to prevent cervical cancer.