HR-HPV Multi-site Opportunistic Screening in Liaoning, China
HR-HPV Multi-site Opportunistic Screening in Liaoning, China
It is universally accepted that the persistent infection of high-risk human
 papillomavirus(HR-HPV) is the cause of cervical intraepithelial neoplasias and cancer. Some
 researches indicate that the virus load may relate the extent of the disease. The objective
 of the study is to detect the virus load of 14 types HR-HPV among the participants, using a
 new HPV DNA hybrid capture technology,sequentially find the diagnostic significance of virus
 load of HPV.
Cervical cancer is the most common malignancy in women, the persistent infection of high-risk
 human papillomavirus(HR-HPV) is the definite cause,especially the infection of human
 papillomavirus 16/human papillomavirus 18(HPV16/HPV18). Some researches indicate the virus
 load may relate the extent of the disease, but the sample capacity is not enough to receive a
 conclusive conclusion. And a specific quantity or a range of virus load which closely relates
 to cervical intraepithelial neoplasia 2(CIN2) or worse is not studied. The aim of the study
 is to prove the association between the virus load and development of cervical
 intraepithelial neoplasias by detecting 14 types HR-HPV, and find the specific quantitative
 value or the range to assist physician to diagnose.

 A detect reagent named Dalton hybrid 3(DH3) is used in the study, the mechanism of which is
 HPV DNA hybrid capture technology, the experimental process include seven steps,
 denaturation, hybridization, the formation of DNA-RNA heterozygote, capture, detect, rinse
 panel, read data.

 Study design: The organizations of the study contain ten hospitals in Liaoning province in
 China,patients accord with inclusion criteria(N=10000) sign informed consent and fill out a
 information form. Gynecologist collect cervical cell with sampling instrument. Detecting the
 virus load of HPV16/HPV18 and other 12 types HR-HPV, the positive result is cut-off
 ≥1.0pg/ml, HPV16/HPV18(+) need colposcopy. The abnormal result of colposcopy requires biopsy,
 the participant who has abnormal result of biopsy need operative treatment. Follow-up
 observation of all participants lasting 5 years are required.
Inclusion Criteria:

 The patients who are voluntary to accept screening with sexual life

 Exclusion Criteria:

 uterectomy, cancer, other serious illness, physical examination(pregnant women are not
 exclusive)