Study On HPV Type Distribution/Smoking And Cervical Cancer And Validation Of A New Screening Method

ObjectivesTo evaluate the status of HPV DNA infection in exfoliated cell, serum antibody levels of HPV6\11\16\18and HPV type distribution in cervical intraepithelial neoplasia from a cross sectional study include5sites in China. The second objective is to access the association between smoking/passive smoking and human papillomavirus (HPV) infection/CIN2+in Chinese women. And to validate the reliability of careHPVTM as a cervical cancer and precancerous lesions screening method in the low resource setting, provide scientific evidence for cervical cancer prevention.Materials and methods1. Use the data of a cross sectional and population-base study, a total of4,215sexually active women were included. Low and high risk HPV types from cervical exfoliated cells were tested with hc2, and some samples were genotyping with Linear Array. CIN1+specimens were genotyping with INNO LiPA form paraffin block. HPV16,18,6and11serum antibodies were detected using a Luminex-based, competitive immunoassay.2. Data were collected from15cross-sectional population-based studies conducted by CICAMS and its national or international collaborators in8provinces, which including15areas during1999to2008. Evaluate the association between smoking/passive smoking and HPV infection/CIN2+.3. Compared three cervical cancer screening methods:careHPVTM, Hybrid Capture2High-Risk HPV DNA Test (hc2) and HPV PCR by evaluating the sensitivity and specificity for detecting high-grade cervical intraepithelial neoplasis (≥CIN2) among459women in Xiangyuan county of Shanxi province, to validate the reliability of careHPVTM.Results1. The average age was37.5±9.7years of women in this study. (1) A total of4,206women with HPV DNA status in exfoliated cell and serum antibody results were included. HPV16prevalence in exfoliated cell peaked in women aged30-34years (4.2%) and45-49years (3.8%), while HPV18prevalence peaked at ages40-44years (1.3%). Most women were dually DNA and serum antibody negative:HPV16(92.2%),18(97.2%), HPV16and18(90.2%), HPV6(92.0%), HPV11(96.6%), HPV6and11(89.9%) and HPV16,18,6and11(82.5%).(2)183cases were diagnosis as CIN2+,162(88.5) typable lesions,153(94.4%) were HPV positive. HPV16was the most prevalent type in lesions in both urban and rural settings. Combined, HPV16and18were attributable to65.9%and75.0%of HPV positive CIN2and CIN3lesions, respectively. In addition, HPV31,33,52and58were prevalent in CIN1+lesions. Though prevalent, HPV31always occurred as a co-infection with another HPV types.3. Smoking rates was2.6%in Chinese women, and passive smoking rate was73.3%. We found no evidence to indicate that smoking is a risk factor for HPV infection (OR=1.06,95%CI:0.87～1.29) and CIN2+(OR=1.33,95%CI:0.83～2.13). Passive smoking was associated with HPV infection (OR=1.15,95%CI:1.02～1.29), but was not associated with CIN2+(OR=0.83,95%CI:0.62～1.13).4. Kappa value and the agreement rate were0.815(P<0.0001), and92.6%(95%CI:89.8%-94.7%), respectively between careHPVTM and hc2; and Kappa value and the agreement rate were0.765(P<0.0001) and90.3%(95%CI:87.3%-92.8%), respectively between careHPVTM and PCR fluorescence detection kit for human papillomavirus.Conclusions and suggestions1. We found in the study of4215women:(1)The HPV infection in cervical exfoliated cells of HPV16and HPV18reached peak at30-34age group, after that, althouth it decrese, but basicall the same as30-34. Before the age of30, there was a high risk to infection HPV16and HPV18. Future national HPV vaccination programs in China should target younger women before30year old. And the HPV prophylactic vaccine will provide a good effection, because the HPV infection rate in exfoliated cell and serum antibody was low.(2) Our study findings suggest that a prophylactic vaccine against HPV16and18is expected to substantially reduce the burden of cervical lesions and cancer in China. In addition, other HPV types, such as33,52, and58play an important role in cervical disease in China, we could consider the introduction to these HPV types in the second-generation vaccine development process.2. The rate of smoking is low in Chinese women, rate of passive smoking is high. Passive smoking is a risk factor of HPV infection.4. careHPVTM is highly consistent with hc2and HPV PCR, which have been approved by State Food and Drug Administration (SFDA).