Cervical cancer ranks as the fourth most common cancer worldwide in women, and it is the eighth most frequent cancer in Chinese population. High risk (HR) human papillomavirus (HPV) is one of the major causes of cervical carcinoma. More than 99% of cervical cancer cases are related to HPV genital infection, which 69.1% of invasive cervical cancer in Chinese population are attributed to HPV HR-subtype 16 or 18. Cervical cancer screening coverage in female population of aged 30-59 years is only 20.9%. This low coverage attributes to the risk of cervical cancer development upon persistent HPV infections. In this study, we therefore investigate the reliability of vaginal specimen collection by self-sampling device (Qvintip, Aprovix) in Chinese population.
Women aged 30±7.3 years (mean±SD, n=281) attending local health clinic between March 2017 and June 2017 were enrolled in this study. Vaginal specimens were obtained by self-sampling device Qvintip with instructions provided. The specimens were subjected to DNA extraction followed by HR HPV DNA screening using commercial Real Time qPCR test kit.
Among the 281 self-sampling devices collected, observable vaginal fluid was observed in 99.3% of the Qvintips (279/281). β-globin and another housekeeping gene were used as endogenous controls for the presence of DNA. The positive rate for internal control was 98.6% (277/281). The overall infection rate of HR-HPV was 10.8%.
The self sampling device had good acceptability with easy process of specimen collection. The drying and short-term storage (2 weeks) of vaginal fluid on Qvintips did not hinder the reconstitution of specimens for analyses. This provides the possibility of self-sample taking at home which could be suitable for remote area population and enable clinical screenings in laboratories later on. Hence, the value of self-sampling at home should be further investigated.
Community based self sampling was a reliable way for vaginal fluid collection for HPV DNA screening. Implementations of HPV self sampling using Qvintip for the responder population as a primary screening tool is highly achievable.