OBJECTIVE: This study aimed to evaluate the role of high risk HPV DNA testing in identifying Chinese younger women with abnormal cytology at risk of harboring cervical intraepithelial neoplasia at grade 2 (CIN2) or worse so as to popularize an effective triage strategy for younger women. METHODS: A total of 246 younger women aged 25 - 36 years old with abnormal cytology were recruited in our study. All were assessed by liquid-based cytology, high-risk HPV DNA test, and colposcopy with directed biopsy and endocervical curettage as necessary. Residual specimens from liquid-based cytology were subjected to real-time PCR testing to identify the presence of 10 high-risk HPV types that are prevalent in China. RESULTS: Among the 246 abnormal cytology samples, 97 (39.4%) were found to be positive for high risk HPV. A clear association was observed between cytological findings and the proportion of patients with positive high risk HPV DNA: namely 29.8% HPV positivity in the ASCUS group; 43.5% in LSIL group; and 90.0% in HSIL group (p<0.01). Overall, high risk HPV test achieved a high specificity (79.8%) and PPV (86.5%) for an endpoint of CIN2+, and higher sensitivity (91.3%) and NPV (98.7%) for an endpoint of CIN3+. For younger women with ASCUS+ cytology, high risk HPV test achieved a higher NPV for CIN2+ and CIN3+ (96.0%, 99.0%). For LISL+ cytology, high risk HPV testing had a high sensitivity with LSIL (90.0%) and HSIL (100%), but there was also a corresponding decrease in specificity. CONCLUSIONS: The results indicate that high risk HPV DNA testing is highly sensitive and moderately specific for CIN grade 2 or worse in women younger than 36 years. LBC primary testing followed by high risk HPV DNA triage improved sensitivity and the false-positive rate for cervical cancer screening and are suitable for developed regions in China.
OBJECTIVE: This study aimed to evaluate the role of high risk HPV DNA testing in identifying Chinese younger women with abnormal cytology at risk of harboring cervical intraepithelial neoplasia at grade 2 (CIN2) or worse so as to popularize an effective triage strategy for younger women. METHODS: A total of 246 younger women aged 25 - 36 years old with abnormal cytology were recruited in our study. All were assessed by liquid-based cytology, high-risk HPV DNA test, and colposcopy with directed biopsy and endocervical curettage as necessary. Residual specimens from liquid-based cytology were subjected to real-time PCR testing to identify the presence of 10 high-risk HPV types that are prevalent in China. RESULTS: Among the 246 abnormal cytology samples, 97 (39.4%) were found to be positive for high risk HPV. A clear association was observed between cytological findings and the proportion of patients with positive high risk HPV DNA: namely 29.8% HPV positivity in the ASCUS group; 43.5% in LSIL group; and 90.0% in HSIL group (p<0.01). Overall, high risk HPV test achieved a high specificity (79.8%) and PPV (86.5%) for an endpoint of CIN2+, and higher sensitivity (91.3%) and NPV (98.7%) for an endpoint of CIN3+. For younger women with ASCUS+ cytology, high risk HPV test achieved a higher NPV for CIN2+ and CIN3+ (96.0%, 99.0%). For LISL+ cytology, high risk HPV testing had a high sensitivity with LSIL (90.0%) and HSIL (100%), but there was also a corresponding decrease in specificity. CONCLUSIONS: The results indicate that high risk HPV DNA testing is highly sensitive and moderately specific for CIN grade 2 or worse in women younger than 36 years. LBC primary testing followed by high risk HPV DNA triage improved sensitivity and the false-positive rate for cervical cancer screening and are suitable for developed regions in China.