| ObjectivesEvaluate the role of HPV16 and HPV 18 genotying and the cervical sample collection medium used for HPV DNA testingin the cervical cancer screening. Promote the implementation of the HPV DNA testing in large scale cervical cancer screening programs in less-developed areas and provide the evidence for the cervical cancer prevention strategy in China.Materials and MethodsFistly, Women from the cervical cancer screening cohort of Xinmi in Henan province were followed up in May 2014. At the baseline, cobas was performed on cytology samples, at the same timeclinician-collected and self-collected specimens were detected by HC2 and careHPV. cobas was performed on the cytological samples from the women atthe follow-up. Evaluate the agreement between cobas and other four tests and compare the cobas with HC2 and careHPV for detecting the cervical intraepithelial neoplasia grade 2 or worse (CIN2+). Investigate the role of the persistent infection of high risk HPV (HR-HPV), HPV 16, HPV16/18 for predicting the cervical precancer. At the same time, we evaluate the role of HPV 16/18 genotyping in the triage of women with ASC-US and LSILthrough a population-based cross-sectional study.Secondly, cervical exfoliated cells specimens were collected and stored in different storage medium in a population-based cross-sectional study. careHPV and HC2 were performed to detect HR-HPV. We evaluate the agreement betweent careHPV and HC2 for detecting HPV in different storage medium. A hospital-based experimental stuty was performed. Women with an abnormal Pap or a HPV-positive result were recruited for participation at colposcopic examination. Enrolled womenhad twocervical specimens collected with a cyto-brush or swab prior to the colposcopic evaluation. In random order these specimens were placed in PreservCyt mediumandin a tube for dry storage. Specimens were randomly assigned to be stored at ambient, uncontrolled temperatures for fixed times:2 days,7 days,14 days, and 28 days, cobas was used to detect HPV DNA. Evaluate the agreement between cytology and swab sample and validity for detecting cervical precancer by cobas.Results1. Sensitivity and Specificity by cobas, HC2 on clinician- and self- collected sample (HC2-C, HC2-S), careHPV on clinician- and self collected sample (careHPV-C, careHPV-S)for detecting CIN2+were94.4% and 63.1%,94.4% and 63.9%,91.7% and 51.9%,94.4% and 65.5%, and 80.6% and 61.5%, respectively. For the women with negative biopsy results, the relative risk (RR) of women with HR-HPV, HPV 16, HPV 16/18 detected by cobas over to women with negative HR-HPV results at the baseline for developing CIN2+were 9.00 (95%CI:1.91-42.35), 22.47 (95%CI:4.52-111.78), and 19.02 (95%CI:3.80-95.12), respectively. The RR of HR-HPV positive women over to HR-HPV negative women detected by HC2-C and careHPV-Cat the baseline for developing CIN2+ were 9.71 (95%CI: 2.05-45.88),4.07 (95%CI:1.18-14.01), respectively. The RR of women who were persistent infection with HR-HPV, HPV16, and HPV16/18 over to women who were HR-HPV negative at the baseline for developing CIN2+ were 24.14 (95%CI: 4.57-127.49),58.01 (95%CI:10.93-307.95), and 47.68 (95%CI:8.88-256.17), respectively.The sensitivity and specificity for detecting CIN2+by HPV 16/18 were 81.8%(95%CI:52.3%-94.9%) and 90.9%(95%CI:87.2%-93.6%) in the women with ASC-US and 66.7%(95%CI:35.4%-87.9%) and 83.8%(95%CI: 73.3%-90.7%) in the women with LSIL.2. The overall agreement rates and Kappa (κ) values of careHPV vs HC2 (STM), careHPV vs HC2 (TCM), and HC2 (STM) vs HC2 (TCM) were 95.8%(κ=0.82), 96.7%(κ=0.86), and 97.2%(κ=0.88), respectively. The sensitivity and specificity by careHPV, HC2 (STM) and HC2 (TCM) for detecting CIN2+ were 70.0% and 87.5%,100.0% and 87.9%, and 90.0% and 87.4%, respectively. The overall agreement rate of HR-HPV, HPV16, HPV18, and other HR-HPV between cytology and swab samples detected by cobas were 93.8%(κ=0.87),97.8% (κ=0.94),99.4%(κ=0.94), and 93.2%(κ=0.86), respectively. The sensitivity and specificity for detecting CIN2+ by the cytology and swab sample detected by cobas were 89.9% and 53.2%, and 91.9% and 52.2%, respectively. The sensitivity and specificity for detecting CIN3+ by the cytology and swab sample were detected by cobas 92.9% and 48.6%, and 93.5% and 47.0%, respectively.Conclusions1. There are good agreement rates between cobas and HC2-C, careHPV-C for detecting CIN2+. Women infected HPV 16/18 have a definitely higher risk for developing CIN2+. The persistent infection of HPV16/18plays a key role for developing CIN2+. HPV 16 and HPV 18 genotyping play an important role for the triage of HR-HPV positive women in the cervical cancer screening.2. There is a good agreement between careHPV and HC2 using different sample collection medium. There is an excellent agreement between cytology and swab sample detected by cobas, even stratified by storage time. Swab collected sample storage can last up to one month without loss of sensitivity and specificity and is simple, inexpensive, and portable, which make cobas HPV testing accessible for cervical cancer screening in low-resource settings. |
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